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The effectiveness of a Chinese midwives’ antenatal clinic service on childbirth outcomes for primipare: A randomised controlled trial
International Journal of Nursing Studies 50 (2013) 1689–1697
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The effectiveness of a Chinese midwives’ antenatal clinic service on childbirth outcomes for primipare: A randomised controlled trial§ Chunyi Gu a,*, Xiaodan Wu a, Yan Ding a, Xinli Zhu b, Zheng Zhang c a b c
Nursing Department, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China Obstetric Out-patient Clinics, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China Labour Unit, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 14 October 2012 Received in revised form 26 April 2013 Accepted 1 May 2013
Background: Antenatal care is an important component of maternity care. In many parts of the world, midwives are the primary caregivers for childbearing women, providing a high level of continuity of care during a normal pregnancy. While in China, obstetricians are the primary providers of antenatal care for all childbearing women; and midwives only provide intrapartum care to labouring women. Today midwifery as a profession in China has been marginalised. Pregnant women usually lack individualised continuity of care from midwives during the perinatal period. There have been few randomised controlled trials of midwifery care practice in mainland China. Objective: (1) To develop and implement a model of Chinese midwives’ antenatal clinic service and (2) to explore its effect on childbirth outcomes, psychological state and satisfaction, for primiparae. Design and methods: Two-group randomised controlled trial. One hundred and ten pregnant women were assessed for eligibility and invited to participate in either the intervention group (midwives’ antenatal clinic service) or the control group (routine antenatal care) in the Obstetrics and Gynaecology Hospital of Fudan University from September 2011 to December 2011. Baseline data were collected, and then women were randomised to individual midwives’ antenatal clinic care (intervention group) or regular antenatal clinic service by obstetricians and obstetric nurse (control group). The research hypothesis was that compared with regular obstetrician-led antenatal care, the midwives’ antenatal clinic service would decrease the caesarean section rate, produce more favourable birth outcomes and women’s greater satisfaction with care. Data were collected by retrospective review of case records and self-report questionnaires. The sample size of 110 was calculated to identify a decrease in caesarean birth from 70% to 40%. Birth outcomes, satisfaction and anxiety score in the two groups were compared. Setting: The midwives’ antenatal clinic in the Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China. Participants: 55 women, attending the midwives’ antenatal clinic (the intervention group) and 55 women, entering the control group. Results: Women in the intervention group were more likely than women in the control group to have a vaginal birth (35 [66.04%] versus 23 [43.40%]; 95% CI for difference 3.69– 41.60). Women in the intervention group had a higher perinatal satisfaction but lower
Keywords: Antenatal clinic Caesarean section Maternal satisfaction Midwife Model of care
§
Trial registration number: ChiCTR-TRC-13003098. * Corresponding author. Tel.: +86 15821932583. E-mail address: [email protected] (C. Gu).
0020-7489/$ – see front matter ß 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijnurstu.2013.05.001
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anxiety score than those in the control group. No differences were seen in neonatal Apgar score and in the amount of bleeding 2 h post partum. Conclusion and implications for practice: The midwives’ antenatal clinic can decrease the rate of caesarean section and enhance women’s satisfaction with midwifery care. Further research needs to be conducted to implement this model of care more widely. We will attempt to make midwifery care a true choice for Chinese women. ß 2013 Elsevier Ltd. All rights reserved.
What is already known about the topic? Much evidence in developed countries and regions supports midwife-managed programmes of antenatal care for low-risk pregnant women. Continuity of midwifery care during pregnancy may lead to reduced caesarean sections and improved maternal psychosocial outcomes. Chinese pregnant women have their antenatal care and checkups by obstetricians and obstetric nurses. Midwives’ antenatal clinic service is rarely implemented and evaluated. What this paper adds This paper demonstrates that the Chinese midwives’ antenatal clinic service decreases the caesarean section rate and increases the vaginal birth rate for primiparaous women. This paper finds that the midwives’ antenatal clinic service enhances women’s satisfaction with midwifery care, which is clinically efficacious. 1. Background Internationally the midwifery care philosophy lies in encouraging natural birth and advocating the midwife-led model of care (Cooke et al., 2004; Bick, 2009; Spiby and Munro, 2009), based on the premise that pregnancy and birth are normal physiological life events. A series of midwife-managed programmes of care have been widely implemented in many developed countries and regions (Turnbull et al., 1996, 2009; Fereday et al., 2009; Wedin et al., 2010), consisting of pregnancy check-ups, care, and parent education. Concurrently, antenatal care is an important component of maternity care. In many parts of the world, midwives are the primary caregivers for childbearing women, providing a high level of continuity of care during a normal pregnancy (Koblinsky et al., 2006; Hildingsson & Radestad, 2005). While in China, maternity health care is an obstetricianled model (Gu et al., 2011). Chinese obstetricians are the primary providers of antenatal care for all childbearing women (Gu et al., 2011), following the more expensive approach of providing such services (Segovia, 1998). Midwives have a long history in China. They used to endure a sustained attack from the male literati and later from the medical profession during dynastic China (Harris et al., 2009). Today Chinese midwifery as a profession has been marginalised (Cheung, 2009). Midwifery care was regarded as unprofitable and disposable, as it was perceived historically as a lower class occupation. Pregnant
women usually lack individualised continuity of care from midwives during the perinatal period. Midwifery education in China was removed from higher education institutions to secondary vocational education in 1952 with sovietisation of education (Xu et al., 2000). Since then it has consisted of two to three years midwifery education in colleges following nine years compulsory education. Four or five years’ bachelors programmes were revived in 1983 (Cheung et al., 2011). Today almost no instances of a university degree for Chinese midwifery have been found, but midwives gain higher university qualifications in nursing (Harris et al., 2009). According to Cheung et al. (2009), the only midwives employed are those who work in labour and delivery rooms in hospitals, most of whom are nurses learning on the job and through an apprenticeship system. An obstetrician (not necessarily the one who provides antenatal care) is present for the birth; midwives provide intrapartum care; and obstetric nurses provide postnatal care. Usually a Chinese midwife provides one-to-one continuous care during labour. The model of one-to-one continuity of care in China commences from the onset of labour until 2 h post partum (Gu et al., 2011), while internationally continuity of midwifery care is implemented by midwives throughout the entire pregnancy, labour, birth and postpartum period (Homer et al., 2002). The marginalisation of Chinese midwifery as a profession has not proved to be the modernisation of maternity care in terms of personal choice, quality of service and professional diversity (Cheung, 2009). There is a consensus now for normal childbirth and the return of the midwifery. A series of reformed midwifery training courses and educational programmes have been carried out in secondary health schools and in colleges and universities, thus providing good opportunities for Chinese clinical midwives to receive higher midwifery continuing education (Gu, 2009; Cheung et al., 2011). A major university hospital in Beijing has commenced a co-operative programme with a New Zealand midwifery provider to further explore and develop midwifery education in China (www.midwifery.com.cn). Meanwhile, there is great concern about the growing proportion of women giving birth by caesarean section in China. As the proportion of caesarean deliveries continues to rise, the number of vaginal deliveries is becoming a less common proportion of total births in China, although midwives retain authority over normal birth in some settings (Harris et al., 2009). In some urban hospitals, caesarean section rates reached 100% (Cheung et al., 2006). Pregnant women’s reluctant attitude towards natural birth, doctor recommendations, maternal request, older
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pregnant women as well as women with co-morbid illnesses and/or fertility problems are regarded as important factors behind the high caesarean section rates (Hou, 2010; Walker et al., 2007; Gunnervik et al., 2010). However, many studies have shown evidence that caregiver support and continuity of midwifery care during pregnancy may lead to reduced caesarean section rates and improved maternal psychosocial outcomes (Harvey et al., 1996; Homer et al., 2001; Hodnett et al., 2010). Adequate prenatal and delivery care are vital components of successful maternal health care provision (Kozhimannil et al., 2009). Midwives’ antenatal care has been well accepted (Wedin et al., 2010) and women favour the provision of education/preparation for birth (Deverill et al., 2010). Maier (2013) noted that women felt a stronger sense of emotional support, reassurance and more in control in midwives’ antenatal care. However, pregnant women in China attend antenatal clinics and have most care and checkups by obstetricians and obstetric nurses. They usually have to spend a long time travelling to the clinic and waiting, spending little time (only few minutes) with the obstetrician due to time constraints. No time is routinely devoted to communication with women for health education. There is great need for personalised information as the time available for women to ask questions at the routine antenatal clinic was inadequate. Hence, the Midwives’ Antenatal Clinic Service project was implemented in this context. It was an extension of the continuity of care in our previous study (Gu et al., 2011) in which there was a lack of midwives’ contact with women in pregnancy, due to the maternity care model in China and lack of midwifery resources. 2. Methods 2.1. Aim The aim of this study was to develop and implement a model of Chinese midwives’ antenatal clinic service; and to compare midwives’ antenatal clinic service and routine obstetrician-led antenatal care in terms of childbirth outcomes, psychological state and women’s satisfaction. Our study was designed to address the hypothesis that compared with routine obstetrician-led antenatal care, the midwives’ antenatal clinic service would result in a lower caesarean section rate, similar (or more favourable) childbirth outcomes, greater satisfaction with care and improved continuity of care and carer.
midwives’ clinic team in consultation with obstetricians) (Fig. 1). At the antenatal clinic, potentially suitable women were seen by a midwife who assessed eligibility as part of the standard history taking. Eligible women were then referred to a member of the research team, who gave a full explanation and provided written information about the study. Women who agreed to participate were asked to give written consent before allocation to a study group. Women in both groups were told that they would have the chance of continuity of midwifery care in labour. Nonconsenting women were referred as usual through the antenatal clinic. A randomisation series was computer-generated in order to allocate participants equally between the two groups. And a simple randomisation scheme was independently prepared by a clerical assistant who was not involved in determining eligibility, providing care, or assessing outcome. Random number 0–4 was allocated into the control group while number 5–9 into the intervention group. The list of random numbers and group allocation were kept concealed in sealed opaque envelopes. Following informed consent, women were randomly allocated to one of the two groups. The group allocation was not revealed until the woman’s details were recorded by the clerical assistant. 2.3. Setting This study was carried out in Fudan University Obstetrics and Gynaecology Hospital, Shanghai, China. The hospital is a specialised teaching hospital in China. There are 21 wards with 777 beds in the hospital including departments of gynaecology, obstetrics, family planning, traditional Chinese medicine combined with western medicine and neonatology. The hospital is comprised of two districts (south and north) and the number of births in each district is about 6000 per year, respectively. Our study was only implemented in the north district of the hospital.
2.2. Design and participants Between September 2011 and December 2011, primiparous women booking for care at antenatal clinics were eligible for the trial if they met the following inclusion criteria: (1) Mandarin-speaking: able to speak, read and write in Chinese; (2) 29–30 weeks gestation at recruitment; (3) low risk at recruitment in absence of medical or obstetrical complications; (4) singleton pregnancy. The exclusion criteria were (1) planned, elective caesarean section; and (2) considered to be at increased medical or obstetric risk (based on criteria developed by the
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Fig. 1. Flow diagram of clinical trial for two study groups.
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In the busy antenatal clinics, due to time constraints, each woman usually has only several minutes to talk with the doctor. Care during labour and birth is mainly provided by obstetricians and midwives. And usually obstetric nurses provide postpartum care to them. The caesarean section rate in the hospital was about 70% from 2009 to 2010. 2.4. Sample size Initial power calculations were based on the caesarean section rate (Homer et al., 2001). Caesarean section is an important clinical outcome that is easy to measure, and has significant physical and emotional implications for women. According to Chen & Chen (2011), the midwives’ antenatal clinic could reduce the caesarean-section rate by 30%. As the caesarean section rate in 2009 in the hospital was 70%, it was hypothesised that the midwives’ antenatal clinic care model would decrease the rate from 70% to 40%. At a significance level of 5% with 80% power, we needed 46 women in each group. Allowing for 20% loss to follow up, 55 women in each group were required, and a total sample size of women was 110. 2.5. Ethical considerations and access Ethical approval was obtained from the Ethics Committee of the Obstetrics and Gynaecology Hospital, Fudan University. Access to undertake the study was given by the head of the obstetric clinic from which the participants were to be recruited. All potential participants were given an information sheet explaining the purpose of the study. They were informed that they had the right to decline to participate and that if they agreed to participate they could subsequently withdraw from the study at any time. All those agreeing to participate were asked to sign a form agreeing to take part. 2.6. Intervention group 2.6.1. Description of midwives’ antenatal clinic service (Table 1) The midwives’ antenatal clinic service was provided by a group of 10 midwives who had been trained to join the midwife clinic. These midwives were in charge of antenatal care procedures for women who had been allocated to the intervention group. Each time the woman attended the obstetrician’s antenatal clinic at the out-patient department, she would also be booked to meet the midwife. Meanwhile, the woman’s husband was encouraged to join the midwives’ clinic as well. Then the midwife would take the time to listen to the women, and for the women and their partners to ask questions in regards to information and support. The midwife usually focussed on antenatal checkups, consultation, making birth plans, parent education, and collaborated with obstetricians and other health professionals as necessary. The midwife would be on call for the woman’s labour and birth except in designated circumstances such as annual leave; sick leave; having already worked more than 16 h in a 24-h period; and having more than one woman in labour. Care would then be provided by an associate midwife. Each woman had a
chance of having continuous one-to-one care from the onset of labour to 2 h post partum. When the woman’s cervix was 2 cm dilated, with contractions occurring 5 to 6 min apart, we described it as the onset of labour. 2.6.2. Recruitment of midwives Ten full-time midwives were required to conduct the intervention. To be eligible, the midwives should have had at least 10-years’ clinical midwifery experience, delivered over 120 babies every year, and should be excellent in communication and midwifery skills. 2.6.3. Training of midwives in the intervention group Midwives in the intervention group were offered a oneday training session by the research team. The training focussed on the research components of the trial and personal skills for each meeting with the woman and her partner. 2.7. Control group 2.7.1. Description of the routine antenatal care Women allocated to the control group were given the routine obstetrician-led antenatal care. These women would line up for some time to register at the hospital clinics; and then they would go to see the obstetrician for consultation, whom might be a different person each time. When women came into the hospital for labour and birth, they would be cared for by whichever midwives and obstetricians were rostered for duty. After the woman’s cervix was dilated 2 cm, each of them also had a chance of receiving one-to-one continuity of care by a duty midwife from the onset of labour to 2 h post partum. 2.8. Outcome measures Childbirth outcomes, women’s psychological state and satisfaction were assessed in this study. Complications were defined as diagnosed by the obstetrician. Clinical data were collected through a retrospective review of medical records by the research team who were not involved in providing care. They examined the maternity case record and the midwifery kardex (used for admissions, antenatal, intrapartum, and postnatal care). Women in the control group had no identifying mark on their records, and clinical staff were unaware whether a particular woman was in the study group or in the control group. We decided not to identify control women because of concern that the identification of the control group would prompt clinical staff to treat these women differently (i.e., the Hawthorne effect). The coders in the research team could not be prevented from knowing the treatment allocation, because the content of the notes implicitly or explicitly revealed the model of care. Regular training sessions were held for coders to attain and keep up acceptable inter-rater agreement. A review of records from each coder was independently examined by one of the investigators (ZXl) to identify and address discrepancies in data collection.
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Table 1 Information details between the intervention group and the control group. Groups Intervention group (midwives’ antenatal clinic service)
Receiving antenatal obstetric care
Similarities 16–24 weeks 24–28 weeks 28–34 weeks 35–40 weeks >40 weeks
Control group (routine obstetrician-led clinic)
Antenatal Antenatal Antenatal Antenatal Antenatal
checkups checkups checkups checkups checkups
every every every every every
4 weeks 3 weeks 2 weeks week 3 days
Receiving continuity of midwifery care in labour Gestation weeks
Differences
29–30 weeks
Establishment of relationships between the midwife and the woman. Face to face talk. Taking medical history. Inquiries about birth intentions. Explaining the advantages of vaginal birth. Making birth plans: request for the birth environment; choices for labour analgesia; the best time for breast feeding. Records and files of above information. Introduction to the environment of labour and delivery room in the form of pictures and presentations. Identification of labour onset. How to handle rupture of membranes. Birth preparation of body and mind. Introduction to coping methods of three labour stages through videos and presentations. Explaining procedures of epidural analgesia. Demonstrations and instructions of Lamaze method; and watching videos. Explanations of one-to-one care service and the importance of fathers’ involvement in pregnancy and labour. Instructions on puerperal care including psychological care, observations of uterine contractions and lochia, breast feeding and neonatal care, et al. Physical examination: abdominal palpation and evaluation of foetal size. Receiving one-to-one continuous care during labour and birth by the same/associate midwife
32 weeks
34–35 weeks
36 weeks
37 weeks 38–40 weeks
Onset of labour
To measure women’s psychological state on admission to groups and to the labour and delivery room (LDR), the Chinese version State-Trait Anxiety Inventory (C-STAI), adapted from the Spielberger State-Trait Inventory (STAI) (Spielberger, 1983), was used. Items 1–20 were State Anxiety Inventory (C-STAI-S) and Items 21–40 were Trait Anxiety Inventory (C-STAI-T). The C-STAI-S inventory adopted in this study used a 4-point Likert scale (Likert, 1932) for each item, with correlation coefficient of testretest scores at 0.88. Each item had a 4-level standard: (1) absolutely none; (2) some; (3) medium; and (4) very obvious. All of the 106 women completed the C-STAI-S inventory on admission to groups. Forty-nine women in the intervention group and 46 women in the control group completed the inventory on admission to LDR. Therefore, the women’s valid response rates at intake and on admission to LDR were 100% and 89.6%, respectively. To measure women’s satisfaction with care, one selfreport questionnaire was developed on the basis of unstructured interviews with women and clinical staff in the hospital, and then extensively tested with women. A pool of items was also developed. The questionnaire was
Watching pregnancy and birth related videos during antenatal periods.
Receiving one-to-one continuous care during labour and birth by a duty midwife
validated by a modified Q-sort methodology which focussed on understanding subjective phenomena from the perspective of the individual (Dennis, 1986). It was administered 42 days post partum when women paid return visits to hospital, which examined their satisfaction with antenatal, intrapartum and postnatal care. A 5-point Likert response format (Likert, 1932) ranging from strongly dissatisfied (point 1) to strongly satisfied (point 5) was used for describing the satisfaction degree in antenatal checkups and care process. A zero-to-ten line was used to describe satisfaction with childbirth experiences in antenatal, intrapartum and postpartum care by placing a cross along the line, 0 was the worst and 10 the best. The questionnaire response rate was 83.2%. 2.9. Statistical analysis We estimated that we could recruit about 110 women during the study period. With this sample size the study would have adequate power to detect significant differences in outcome measures such as caesarean section, vaginal birth, amount of vaginal bleeding post partum,
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Table 2 Baseline characteristics of participants. Characteristics
Values
All, N = 106 (%)
Intervention group, n = 53 (%)
Control group, n = 53 (%)
Women’s age, years Gradiva, number Weight, kg Height, cm
Mean SD Mean SD Mean SD Mean SD
29.01 2.55 1.33 0.69 60.95 16.40 162.45 4.70
28.74 2.42 1.40 0.72 60.03 13.77 162.30 4.64
29.28 2.68 1.26 0.66 61.88 18.76 162.60 4.79
Education level High school or below College Bachelor Master or above
11 29 50 16
(10.37%) (27.36%) (47.17%) (15.09%)
5 (9.40%) 16 (30.19%) 25 (47.17%) 7 (13.21%)
6 (11.32%) 13 (24.53%) 25 (47.17%) 9 (16.98%)
Vocation Company employee Technician Liberal profession Unemployed Foetal biparietal diameter
37 (34.91%) 38 (35.85%) 12 (11.32%) 19 (17.92%) 84.02 2.98
18 (33.96%) 20 (37.74%) 7 (13.21%) 8 (15.09%) 84.06 3.18
19 (35.85%) 18 (33.96%) 5 (9.43%) 11 (20.75%) 84.02 2.80
Mean SD
neonatal Apgar score, women’s psychological state and satisfaction with care. Analyses were carried out by intention to treat (ITT). Data were entered onto computer and statistical analyses were conducted using the Statistical Package for Social Science (SPSS), Version 16.0. Categorical data were analysed by x2 tests. 95% confidence intervals (95% CI) were calculated. And 95% CI that do not bracket zero indicate a statistically significant difference. Mean values were compared by two-sample t tests. P values of less than 0.05 were taken to be statistically significant. All differences were presented as the value for midwives’ antenatal clinic service minus that for obstetrician-led care. 3. Results 3.1. Characteristics of the participants Fig. 1 shows the flow of participants through the trial. Of the 110 eligible women who consented to take part in the study, 55 women were assigned routine obstetricianled care and 55 midwives’ antenatal clinic care. Two women in each group chose to give birth in other hospitals and they were lost to follow up. Three women in the intervention group and two women in the control group withdrew immediately from the study. But the delivery modes of these women were still followed up through chart review, eventually resulting in 53 participants in each group. Two women who withdrew from each group had caesarean sections and one in the intervention group had a vaginal birth. The baseline characteristics of women were similar in the two groups (Table 2). There were no differences between the two groups in women’s age, parity, education level, socioeconomic status and foetal biparietal diameter at 32 weeks gestation. In the intervention group, 47 women had their husband with them at the midwives’ antenatal clinic. And each time the woman met the midwife, her husband would also attend the clinic. All of the women in both groups received continuity of midwifery care in labour.
3.2. Childbirth outcome measures Women in the midwives’ antenatal clinic service group were less likely to have a caesarean birth compared with women in obstetrician-led care group (18 [33.96%] versus 30 [56.60%]; 95% CI for difference 41.60 to 3.69) (Table 3). We found no differences between the two groups in the neonatal Apgar scores and the amount of bleeding 2 h post partum (Table 3). 3.3. Maternal psychological state and satisfaction The mean S-AI scores at intake were 36.15 8.29 in the intervention group, and 37.75 9.39 in the control group, making no significant differences between the two groups (P > 0.05; 95% CI 5.02 to 1.81). Women’s mean S-AI scores when they were on admission to LDR were 38.73 10.10 in the intervention group and 46.09 8.96 in the control group, respectively, giving significant differences between the two groups (P < 0.001; 95% CI 11.25 to 3.45) (Table 4). Table 4 also shows that women in the intervention group expressed greater satisfaction with perinatal experiences (95% CI 0.65–1.40; P < 0.001) and greater satisfaction with antenatal clinic care (P < 0.05) than women in the routine care group. 4. Discussion This study was a pioneering trial evaluating the effectiveness of midwives’ antenatal clinic service model in China. And it was delivered in an obstetrician-led setting, which inevitably affects practice and therefore the findings. The fact that provision of similar service within other settings may yield different results should be borne in mind when the findings are applied elsewhere. A limitation of the study was the absence of midwifery care in the first two trimesters of pregnancy. Midwifery care was only provided in the last trimester of pregnancy (after 28 weeks gestation). This was due to lack of more midwifery resources. However, this study expanded Chinese midwives’ former working scope and it was an extension of our previous study in which midwives were
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Table 3 Maternal and infant outcomes.
Number (%) with mode of delivery Caesarean section Vaginal birth Mean (SD) blood loss 2 h post partum Neonatal Apgar score, n (%) 8–10 at 1 min 8–10 at 5 min a
Intervention group (n = 53)
Control group (n = 53)
Difference (95% CI)
P value
18 (33.96%) 35 (66.04%) 179.34 (34.92)
30 (56.60%) 23 (43.40%) 188.21 (60.92)
22.64% ( 41.60 to 3.69) 22.64% (3.69–41.60) 8.87 ( 27.99 to 10.26)
0.019a
50 (94.34%) 53 (100%)
51 (96.23%) 52 (98.11%)
1.89% ( 39.05 to 35.28) 1.89% ( 36.01 to 39.78)
0.921 0.922
0.360
x2 test.
only confined to the labour and delivery unit. Another limitation of our study was the absence and difficulty of blinding. Our study examined the efficacy of midwives’ antenatal clinic service, women’s psychological state and satisfaction with such care model. While the sample size was small, the results suggested that this is a beneficial model of antenatal care that has the potential to be implemented and evaluated more widely in China. Differences between midwifery and other models of care often include variations in philosophy, focus, relationship between the care provider and the pregnant woman (Sandall et al., 2009), and in the goals and objectives of care (Rooks, 1999). The midwives’ antenatal clinic service in this study just upheld the philosophy that pregnancy and birth are normal physiological life events; emphasised midwives’ continuity of care during the antenatal period, and focussed on the woman-midwife relationship, the provision of consistent advice and information, which was rarely mentioned elsewhere in China but had been extensively used in developed countries (Johnson et al., 2003; Cooke et al., 2004; Sandall et al., 2009). We found in our study that compared with routine obstetrician-led antenatal care, the midwives’ antenatal clinic service resulted in a reduced caesarean section rate, increased vaginal birth rate, and greater satisfaction with care, which was in keeping with findings from the studies of Homer et al. (2001), Johnson et al. (2005), Kuo et al. (2010), Williams et al. (2010) and McLachlan et al. (2012). The original hypothesis was therefore supported. However, differences in caesarean section rates have not been found in some trials of midwifery care (Hatem et al., 2008; Waldenstrom and Turnbull, 1998), which is in contrast to our primary finding. It is uncertain what component of the
midwives’ clinic care model in our study caused the reduction of the caesarean section rate. But the two trials of 2314 and 1089 women, respectively, also demonstrated significant differences (Homer et al., 2001; McLachlan et al., 2012). Meanwhile, our study showed that the caesarean section rate was 33.96% in the intervention group and 56.60% in the control group. As the general hospital caesarean section rate in 2009 was 70%, it can be seen that the rates in both groups were reduced to different degrees. In addition, 50% women who received continuity of labour care in our previous study (Gu et al., 2011) had caesarean sections, which was similar to those in the control group in our present study. The fact that women in the obstetricianled antenatal care group received continuity of labour care might possibly explain the reason why these women’s caesarean section rate was reduced from 70% to 56.60%. Therefore, it can be inferred that midwives’ involvement in antenatal clinic and continuity of labour care is of crucial importance in the process of providing midwifery care. The greatest differences between the two groups were in antenatal and intrapartum care. Women in the intervention group always had a named midwife who aimed to provide the majority of care in the late trimester and during labour, whereas women in the routine care group received care from several different people including obstetricians and nurses. Homer et al. (2002) also noted that women who had a known midwife during labour had a significantly higher sense of ‘control’ and a more positive birth experience compared with women who reported an unknown midwife. According to Devane et al. (2007), encouragement, assistance and advice were essential elements in providing midwifery care. Midwives in our study had just made full
Table 4 Maternal anxiety level and satisfaction with maternity care. Intervention group (n = 53) Mean (SD) scores of C-STAI-S On admission to groups (53/53)a 36.15 (8.29) On admission to LDR (49/46)a 38.73 (10.10) Satisfaction with perinatal care experience (scores), (44/40)a Mean (SD) 9.00 (0.75) Satisfaction with antenatal clinic care service (44/40)a, n (%) Strongly satisfied/satisfied 31 (70.5%) Not sure 12 (27.3%) Strong-dissatisfied/dissatisfied 1 (2.3%) a b
Control group (n = 53) 37.75 (9.39) 46.09 (8.96) 7.98 (0.95) 15 (37.5%) 20 (50.0%) 5 (12.5%)
Difference (95% CI) 1.6 ( 5.02 to 1.81) 7.35 ( 11.25 to 3.45)
P value 0.353 0.000
1.02 (0.65–1.40)
0.000
x2 = 10.06
0.007b
Numbers in parentheses indicate number for whom this information was available (intervention group/control group). x2 test.
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use of these key points and developed a close rapport with the woman since the late trimester of pregnancy. With the aim of facilitating more choice, continuity and control for women, midwives in the intervention group were in partnership with the woman, responsible for assessment of her care needs, making individualised care plans for her, and also gaining interaction with the woman, which might be the reason why more women in the intervention group chose to give birth vaginally than those in the control group. Concurrently, for variables for which we set out to test equivalence (e.g., amount of vaginal bleeding and neonatal Apgar score), we found no statistically significant differences, which indicated that the midwives’ antenatal clinic service model did not adversely affect these variables, or further investigations are still required due to the smaller sample size in our study. As Hildingsson and Radestad (2005) have pointed out, psychosocial aspects of care, information and caregiver support are factors associated with antenatal satisfaction; while inappropriate time allocated to antenatal check-ups and lack of support from midwives are identified as sources of dissatisfaction. We found in our study that women receiving the midwives’ antenatal clinic service reported greater satisfaction with antenatal care and their perinatal experiences than those receiving routine care. Similar to other studies of midwifery care (Hodnett, 2001; Shields et al., 1998), women were more highly satisfied in relationships with midwives, information transfer, choices and decisions, and more pleased with midwives’ providing antenatal and intrapartum care (Villar et al., 2001). However, we acknowledge that the response rate of our satisfaction questionnaire was only 83.2%, which was also a weakness in our study. On the one hand, midwives’ professional instruction in the intervention group could help women be well prepared for labour and birth, and get command of breathing techniques and other coping methods. On the other hand, the midwife and the woman always had plenty of topics to discuss and consulting time each time they met. The woman could keep in contact with the midwife to receive individualised continuity of care during the perinatal period, thus creating a more relaxed atmosphere. This is in agreement with Page et al. (2000)’s statement that continuity of care and carer are important determinants of a positive childbirth experience. The women in the intervention group were always in good partnership with their midwife. They felt that their expectations with care had been fulfilled and had positively responded to the partnership midwifery practice, which is supported by Johnson et al.’s (2003) study. Additionally, we found in this study that women’s S-AI scores between the two groups had no significant differences at intake. However, women in the routine care group had much higher S-AI scores than those in the intervention group when admitted to LDR, which indicated that the midwives’ antenatal clinic service could lower maternal anxiety to some degree, while women in the routine obstetrician-led care group became more anxious with the increase in their gestational age. As Cheung et al. (2007) noted in their study, there was a significant
negative relationship between maternal anxiety and feelings of control during labour. Gibbins and Thomson (2001) also pointed out that maternal feelings of control during labour might help in decreasing the level of anxiety during pregnancy. Support from midwives was one of the effective methods to reduce the level of maternal anxiety (Halldorsdottir and Karlsdottir, 1996). In our study, expectant fathers were encouraged to attend the midwives’ antenatal clinic and give the woman adequate and effective support, thus helping the woman gain positive experiences during the perinatal period, which is supported by other studies (Hildingsson and Radestad, 2005; Sercekus and Mete, 2010). Consequently, the creation of a trusting relationship between the midwife, the woman and her partner is particularly important to improve the pregnancy and childbirth experiences. We consider this as the premise to successfully implement our new model of midwifery care.
5. Conclusion and implications for practice A new Chinese midwives’ antenatal clinic care model was implemented in this study, using a randomised controlled trial design to explore its effect on childbirth outcomes, psychological state and satisfaction, for primiparae. We conclude that the midwives’ antenatal clinic service is clinically efficacious, which has decreased the rate of caesarean section and enhanced Chinese women’s satisfaction with midwifery care. Accordingly, we consider this model as a new approach for Chinese midwives to provide continuity of care for pregnant and labouring women, and to expand midwives’ working scopes and job roles. Only in this way can the Chinese midwives keep up with the international trends and developments in midwifery. And we will attempt to make midwifery care a true choice for Chinese women. However, midwives’ competences and their education levels still need to be developed and evaluated if we implement this model of care more widely in China. Variables such as the rates of antenatal hospitalisation, episiotomy, intrapartum analgesia and breastfeeding, need to be further explored. Our future efforts will be focussed on the midwives’ involvement in the entire perinatal period by acquiring more midwifery resources. Conflict of interest: None declared. Funding: The Nursing School of Fudan University Fund supported the research and governed the progress and review of this study (No. FNF201004). Ethical approval: Ethical approval was obtained from the Obstetrics and Gynaecology Hospital Ethics Committee of Fudan University (OGHEC[2010]28). Acknowledgements This study was supported by the Nursing School of Fudan University, Shanghai, China. The authors would like to thank the women who participated in our study and pay tribute to the midwife trainers and hospitals for supporting this project. We would also like to express our thanks to all
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International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns
The effectiveness of a Chinese midwives’ antenatal clinic service on childbirth outcomes for primipare: A randomised controlled trial§ Chunyi Gu a,*, Xiaodan Wu a, Yan Ding a, Xinli Zhu b, Zheng Zhang c a b c
Nursing Department, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China Obstetric Out-patient Clinics, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China Labour Unit, Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 14 October 2012 Received in revised form 26 April 2013 Accepted 1 May 2013
Background: Antenatal care is an important component of maternity care. In many parts of the world, midwives are the primary caregivers for childbearing women, providing a high level of continuity of care during a normal pregnancy. While in China, obstetricians are the primary providers of antenatal care for all childbearing women; and midwives only provide intrapartum care to labouring women. Today midwifery as a profession in China has been marginalised. Pregnant women usually lack individualised continuity of care from midwives during the perinatal period. There have been few randomised controlled trials of midwifery care practice in mainland China. Objective: (1) To develop and implement a model of Chinese midwives’ antenatal clinic service and (2) to explore its effect on childbirth outcomes, psychological state and satisfaction, for primiparae. Design and methods: Two-group randomised controlled trial. One hundred and ten pregnant women were assessed for eligibility and invited to participate in either the intervention group (midwives’ antenatal clinic service) or the control group (routine antenatal care) in the Obstetrics and Gynaecology Hospital of Fudan University from September 2011 to December 2011. Baseline data were collected, and then women were randomised to individual midwives’ antenatal clinic care (intervention group) or regular antenatal clinic service by obstetricians and obstetric nurse (control group). The research hypothesis was that compared with regular obstetrician-led antenatal care, the midwives’ antenatal clinic service would decrease the caesarean section rate, produce more favourable birth outcomes and women’s greater satisfaction with care. Data were collected by retrospective review of case records and self-report questionnaires. The sample size of 110 was calculated to identify a decrease in caesarean birth from 70% to 40%. Birth outcomes, satisfaction and anxiety score in the two groups were compared. Setting: The midwives’ antenatal clinic in the Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China. Participants: 55 women, attending the midwives’ antenatal clinic (the intervention group) and 55 women, entering the control group. Results: Women in the intervention group were more likely than women in the control group to have a vaginal birth (35 [66.04%] versus 23 [43.40%]; 95% CI for difference 3.69– 41.60). Women in the intervention group had a higher perinatal satisfaction but lower
Keywords: Antenatal clinic Caesarean section Maternal satisfaction Midwife Model of care
§
Trial registration number: ChiCTR-TRC-13003098. * Corresponding author. Tel.: +86 15821932583. E-mail address: [email protected] (C. Gu).
0020-7489/$ – see front matter ß 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijnurstu.2013.05.001
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anxiety score than those in the control group. No differences were seen in neonatal Apgar score and in the amount of bleeding 2 h post partum. Conclusion and implications for practice: The midwives’ antenatal clinic can decrease the rate of caesarean section and enhance women’s satisfaction with midwifery care. Further research needs to be conducted to implement this model of care more widely. We will attempt to make midwifery care a true choice for Chinese women. ß 2013 Elsevier Ltd. All rights reserved.
What is already known about the topic? Much evidence in developed countries and regions supports midwife-managed programmes of antenatal care for low-risk pregnant women. Continuity of midwifery care during pregnancy may lead to reduced caesarean sections and improved maternal psychosocial outcomes. Chinese pregnant women have their antenatal care and checkups by obstetricians and obstetric nurses. Midwives’ antenatal clinic service is rarely implemented and evaluated. What this paper adds This paper demonstrates that the Chinese midwives’ antenatal clinic service decreases the caesarean section rate and increases the vaginal birth rate for primiparaous women. This paper finds that the midwives’ antenatal clinic service enhances women’s satisfaction with midwifery care, which is clinically efficacious. 1. Background Internationally the midwifery care philosophy lies in encouraging natural birth and advocating the midwife-led model of care (Cooke et al., 2004; Bick, 2009; Spiby and Munro, 2009), based on the premise that pregnancy and birth are normal physiological life events. A series of midwife-managed programmes of care have been widely implemented in many developed countries and regions (Turnbull et al., 1996, 2009; Fereday et al., 2009; Wedin et al., 2010), consisting of pregnancy check-ups, care, and parent education. Concurrently, antenatal care is an important component of maternity care. In many parts of the world, midwives are the primary caregivers for childbearing women, providing a high level of continuity of care during a normal pregnancy (Koblinsky et al., 2006; Hildingsson & Radestad, 2005). While in China, maternity health care is an obstetricianled model (Gu et al., 2011). Chinese obstetricians are the primary providers of antenatal care for all childbearing women (Gu et al., 2011), following the more expensive approach of providing such services (Segovia, 1998). Midwives have a long history in China. They used to endure a sustained attack from the male literati and later from the medical profession during dynastic China (Harris et al., 2009). Today Chinese midwifery as a profession has been marginalised (Cheung, 2009). Midwifery care was regarded as unprofitable and disposable, as it was perceived historically as a lower class occupation. Pregnant
women usually lack individualised continuity of care from midwives during the perinatal period. Midwifery education in China was removed from higher education institutions to secondary vocational education in 1952 with sovietisation of education (Xu et al., 2000). Since then it has consisted of two to three years midwifery education in colleges following nine years compulsory education. Four or five years’ bachelors programmes were revived in 1983 (Cheung et al., 2011). Today almost no instances of a university degree for Chinese midwifery have been found, but midwives gain higher university qualifications in nursing (Harris et al., 2009). According to Cheung et al. (2009), the only midwives employed are those who work in labour and delivery rooms in hospitals, most of whom are nurses learning on the job and through an apprenticeship system. An obstetrician (not necessarily the one who provides antenatal care) is present for the birth; midwives provide intrapartum care; and obstetric nurses provide postnatal care. Usually a Chinese midwife provides one-to-one continuous care during labour. The model of one-to-one continuity of care in China commences from the onset of labour until 2 h post partum (Gu et al., 2011), while internationally continuity of midwifery care is implemented by midwives throughout the entire pregnancy, labour, birth and postpartum period (Homer et al., 2002). The marginalisation of Chinese midwifery as a profession has not proved to be the modernisation of maternity care in terms of personal choice, quality of service and professional diversity (Cheung, 2009). There is a consensus now for normal childbirth and the return of the midwifery. A series of reformed midwifery training courses and educational programmes have been carried out in secondary health schools and in colleges and universities, thus providing good opportunities for Chinese clinical midwives to receive higher midwifery continuing education (Gu, 2009; Cheung et al., 2011). A major university hospital in Beijing has commenced a co-operative programme with a New Zealand midwifery provider to further explore and develop midwifery education in China (www.midwifery.com.cn). Meanwhile, there is great concern about the growing proportion of women giving birth by caesarean section in China. As the proportion of caesarean deliveries continues to rise, the number of vaginal deliveries is becoming a less common proportion of total births in China, although midwives retain authority over normal birth in some settings (Harris et al., 2009). In some urban hospitals, caesarean section rates reached 100% (Cheung et al., 2006). Pregnant women’s reluctant attitude towards natural birth, doctor recommendations, maternal request, older
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pregnant women as well as women with co-morbid illnesses and/or fertility problems are regarded as important factors behind the high caesarean section rates (Hou, 2010; Walker et al., 2007; Gunnervik et al., 2010). However, many studies have shown evidence that caregiver support and continuity of midwifery care during pregnancy may lead to reduced caesarean section rates and improved maternal psychosocial outcomes (Harvey et al., 1996; Homer et al., 2001; Hodnett et al., 2010). Adequate prenatal and delivery care are vital components of successful maternal health care provision (Kozhimannil et al., 2009). Midwives’ antenatal care has been well accepted (Wedin et al., 2010) and women favour the provision of education/preparation for birth (Deverill et al., 2010). Maier (2013) noted that women felt a stronger sense of emotional support, reassurance and more in control in midwives’ antenatal care. However, pregnant women in China attend antenatal clinics and have most care and checkups by obstetricians and obstetric nurses. They usually have to spend a long time travelling to the clinic and waiting, spending little time (only few minutes) with the obstetrician due to time constraints. No time is routinely devoted to communication with women for health education. There is great need for personalised information as the time available for women to ask questions at the routine antenatal clinic was inadequate. Hence, the Midwives’ Antenatal Clinic Service project was implemented in this context. It was an extension of the continuity of care in our previous study (Gu et al., 2011) in which there was a lack of midwives’ contact with women in pregnancy, due to the maternity care model in China and lack of midwifery resources. 2. Methods 2.1. Aim The aim of this study was to develop and implement a model of Chinese midwives’ antenatal clinic service; and to compare midwives’ antenatal clinic service and routine obstetrician-led antenatal care in terms of childbirth outcomes, psychological state and women’s satisfaction. Our study was designed to address the hypothesis that compared with routine obstetrician-led antenatal care, the midwives’ antenatal clinic service would result in a lower caesarean section rate, similar (or more favourable) childbirth outcomes, greater satisfaction with care and improved continuity of care and carer.
midwives’ clinic team in consultation with obstetricians) (Fig. 1). At the antenatal clinic, potentially suitable women were seen by a midwife who assessed eligibility as part of the standard history taking. Eligible women were then referred to a member of the research team, who gave a full explanation and provided written information about the study. Women who agreed to participate were asked to give written consent before allocation to a study group. Women in both groups were told that they would have the chance of continuity of midwifery care in labour. Nonconsenting women were referred as usual through the antenatal clinic. A randomisation series was computer-generated in order to allocate participants equally between the two groups. And a simple randomisation scheme was independently prepared by a clerical assistant who was not involved in determining eligibility, providing care, or assessing outcome. Random number 0–4 was allocated into the control group while number 5–9 into the intervention group. The list of random numbers and group allocation were kept concealed in sealed opaque envelopes. Following informed consent, women were randomly allocated to one of the two groups. The group allocation was not revealed until the woman’s details were recorded by the clerical assistant. 2.3. Setting This study was carried out in Fudan University Obstetrics and Gynaecology Hospital, Shanghai, China. The hospital is a specialised teaching hospital in China. There are 21 wards with 777 beds in the hospital including departments of gynaecology, obstetrics, family planning, traditional Chinese medicine combined with western medicine and neonatology. The hospital is comprised of two districts (south and north) and the number of births in each district is about 6000 per year, respectively. Our study was only implemented in the north district of the hospital.
2.2. Design and participants Between September 2011 and December 2011, primiparous women booking for care at antenatal clinics were eligible for the trial if they met the following inclusion criteria: (1) Mandarin-speaking: able to speak, read and write in Chinese; (2) 29–30 weeks gestation at recruitment; (3) low risk at recruitment in absence of medical or obstetrical complications; (4) singleton pregnancy. The exclusion criteria were (1) planned, elective caesarean section; and (2) considered to be at increased medical or obstetric risk (based on criteria developed by the
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Fig. 1. Flow diagram of clinical trial for two study groups.
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In the busy antenatal clinics, due to time constraints, each woman usually has only several minutes to talk with the doctor. Care during labour and birth is mainly provided by obstetricians and midwives. And usually obstetric nurses provide postpartum care to them. The caesarean section rate in the hospital was about 70% from 2009 to 2010. 2.4. Sample size Initial power calculations were based on the caesarean section rate (Homer et al., 2001). Caesarean section is an important clinical outcome that is easy to measure, and has significant physical and emotional implications for women. According to Chen & Chen (2011), the midwives’ antenatal clinic could reduce the caesarean-section rate by 30%. As the caesarean section rate in 2009 in the hospital was 70%, it was hypothesised that the midwives’ antenatal clinic care model would decrease the rate from 70% to 40%. At a significance level of 5% with 80% power, we needed 46 women in each group. Allowing for 20% loss to follow up, 55 women in each group were required, and a total sample size of women was 110. 2.5. Ethical considerations and access Ethical approval was obtained from the Ethics Committee of the Obstetrics and Gynaecology Hospital, Fudan University. Access to undertake the study was given by the head of the obstetric clinic from which the participants were to be recruited. All potential participants were given an information sheet explaining the purpose of the study. They were informed that they had the right to decline to participate and that if they agreed to participate they could subsequently withdraw from the study at any time. All those agreeing to participate were asked to sign a form agreeing to take part. 2.6. Intervention group 2.6.1. Description of midwives’ antenatal clinic service (Table 1) The midwives’ antenatal clinic service was provided by a group of 10 midwives who had been trained to join the midwife clinic. These midwives were in charge of antenatal care procedures for women who had been allocated to the intervention group. Each time the woman attended the obstetrician’s antenatal clinic at the out-patient department, she would also be booked to meet the midwife. Meanwhile, the woman’s husband was encouraged to join the midwives’ clinic as well. Then the midwife would take the time to listen to the women, and for the women and their partners to ask questions in regards to information and support. The midwife usually focussed on antenatal checkups, consultation, making birth plans, parent education, and collaborated with obstetricians and other health professionals as necessary. The midwife would be on call for the woman’s labour and birth except in designated circumstances such as annual leave; sick leave; having already worked more than 16 h in a 24-h period; and having more than one woman in labour. Care would then be provided by an associate midwife. Each woman had a
chance of having continuous one-to-one care from the onset of labour to 2 h post partum. When the woman’s cervix was 2 cm dilated, with contractions occurring 5 to 6 min apart, we described it as the onset of labour. 2.6.2. Recruitment of midwives Ten full-time midwives were required to conduct the intervention. To be eligible, the midwives should have had at least 10-years’ clinical midwifery experience, delivered over 120 babies every year, and should be excellent in communication and midwifery skills. 2.6.3. Training of midwives in the intervention group Midwives in the intervention group were offered a oneday training session by the research team. The training focussed on the research components of the trial and personal skills for each meeting with the woman and her partner. 2.7. Control group 2.7.1. Description of the routine antenatal care Women allocated to the control group were given the routine obstetrician-led antenatal care. These women would line up for some time to register at the hospital clinics; and then they would go to see the obstetrician for consultation, whom might be a different person each time. When women came into the hospital for labour and birth, they would be cared for by whichever midwives and obstetricians were rostered for duty. After the woman’s cervix was dilated 2 cm, each of them also had a chance of receiving one-to-one continuity of care by a duty midwife from the onset of labour to 2 h post partum. 2.8. Outcome measures Childbirth outcomes, women’s psychological state and satisfaction were assessed in this study. Complications were defined as diagnosed by the obstetrician. Clinical data were collected through a retrospective review of medical records by the research team who were not involved in providing care. They examined the maternity case record and the midwifery kardex (used for admissions, antenatal, intrapartum, and postnatal care). Women in the control group had no identifying mark on their records, and clinical staff were unaware whether a particular woman was in the study group or in the control group. We decided not to identify control women because of concern that the identification of the control group would prompt clinical staff to treat these women differently (i.e., the Hawthorne effect). The coders in the research team could not be prevented from knowing the treatment allocation, because the content of the notes implicitly or explicitly revealed the model of care. Regular training sessions were held for coders to attain and keep up acceptable inter-rater agreement. A review of records from each coder was independently examined by one of the investigators (ZXl) to identify and address discrepancies in data collection.
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Table 1 Information details between the intervention group and the control group. Groups Intervention group (midwives’ antenatal clinic service)
Receiving antenatal obstetric care
Similarities 16–24 weeks 24–28 weeks 28–34 weeks 35–40 weeks >40 weeks
Control group (routine obstetrician-led clinic)
Antenatal Antenatal Antenatal Antenatal Antenatal
checkups checkups checkups checkups checkups
every every every every every
4 weeks 3 weeks 2 weeks week 3 days
Receiving continuity of midwifery care in labour Gestation weeks
Differences
29–30 weeks
Establishment of relationships between the midwife and the woman. Face to face talk. Taking medical history. Inquiries about birth intentions. Explaining the advantages of vaginal birth. Making birth plans: request for the birth environment; choices for labour analgesia; the best time for breast feeding. Records and files of above information. Introduction to the environment of labour and delivery room in the form of pictures and presentations. Identification of labour onset. How to handle rupture of membranes. Birth preparation of body and mind. Introduction to coping methods of three labour stages through videos and presentations. Explaining procedures of epidural analgesia. Demonstrations and instructions of Lamaze method; and watching videos. Explanations of one-to-one care service and the importance of fathers’ involvement in pregnancy and labour. Instructions on puerperal care including psychological care, observations of uterine contractions and lochia, breast feeding and neonatal care, et al. Physical examination: abdominal palpation and evaluation of foetal size. Receiving one-to-one continuous care during labour and birth by the same/associate midwife
32 weeks
34–35 weeks
36 weeks
37 weeks 38–40 weeks
Onset of labour
To measure women’s psychological state on admission to groups and to the labour and delivery room (LDR), the Chinese version State-Trait Anxiety Inventory (C-STAI), adapted from the Spielberger State-Trait Inventory (STAI) (Spielberger, 1983), was used. Items 1–20 were State Anxiety Inventory (C-STAI-S) and Items 21–40 were Trait Anxiety Inventory (C-STAI-T). The C-STAI-S inventory adopted in this study used a 4-point Likert scale (Likert, 1932) for each item, with correlation coefficient of testretest scores at 0.88. Each item had a 4-level standard: (1) absolutely none; (2) some; (3) medium; and (4) very obvious. All of the 106 women completed the C-STAI-S inventory on admission to groups. Forty-nine women in the intervention group and 46 women in the control group completed the inventory on admission to LDR. Therefore, the women’s valid response rates at intake and on admission to LDR were 100% and 89.6%, respectively. To measure women’s satisfaction with care, one selfreport questionnaire was developed on the basis of unstructured interviews with women and clinical staff in the hospital, and then extensively tested with women. A pool of items was also developed. The questionnaire was
Watching pregnancy and birth related videos during antenatal periods.
Receiving one-to-one continuous care during labour and birth by a duty midwife
validated by a modified Q-sort methodology which focussed on understanding subjective phenomena from the perspective of the individual (Dennis, 1986). It was administered 42 days post partum when women paid return visits to hospital, which examined their satisfaction with antenatal, intrapartum and postnatal care. A 5-point Likert response format (Likert, 1932) ranging from strongly dissatisfied (point 1) to strongly satisfied (point 5) was used for describing the satisfaction degree in antenatal checkups and care process. A zero-to-ten line was used to describe satisfaction with childbirth experiences in antenatal, intrapartum and postpartum care by placing a cross along the line, 0 was the worst and 10 the best. The questionnaire response rate was 83.2%. 2.9. Statistical analysis We estimated that we could recruit about 110 women during the study period. With this sample size the study would have adequate power to detect significant differences in outcome measures such as caesarean section, vaginal birth, amount of vaginal bleeding post partum,
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Table 2 Baseline characteristics of participants. Characteristics
Values
All, N = 106 (%)
Intervention group, n = 53 (%)
Control group, n = 53 (%)
Women’s age, years Gradiva, number Weight, kg Height, cm
Mean SD Mean SD Mean SD Mean SD
29.01 2.55 1.33 0.69 60.95 16.40 162.45 4.70
28.74 2.42 1.40 0.72 60.03 13.77 162.30 4.64
29.28 2.68 1.26 0.66 61.88 18.76 162.60 4.79
Education level High school or below College Bachelor Master or above
11 29 50 16
(10.37%) (27.36%) (47.17%) (15.09%)
5 (9.40%) 16 (30.19%) 25 (47.17%) 7 (13.21%)
6 (11.32%) 13 (24.53%) 25 (47.17%) 9 (16.98%)
Vocation Company employee Technician Liberal profession Unemployed Foetal biparietal diameter
37 (34.91%) 38 (35.85%) 12 (11.32%) 19 (17.92%) 84.02 2.98
18 (33.96%) 20 (37.74%) 7 (13.21%) 8 (15.09%) 84.06 3.18
19 (35.85%) 18 (33.96%) 5 (9.43%) 11 (20.75%) 84.02 2.80
Mean SD
neonatal Apgar score, women’s psychological state and satisfaction with care. Analyses were carried out by intention to treat (ITT). Data were entered onto computer and statistical analyses were conducted using the Statistical Package for Social Science (SPSS), Version 16.0. Categorical data were analysed by x2 tests. 95% confidence intervals (95% CI) were calculated. And 95% CI that do not bracket zero indicate a statistically significant difference. Mean values were compared by two-sample t tests. P values of less than 0.05 were taken to be statistically significant. All differences were presented as the value for midwives’ antenatal clinic service minus that for obstetrician-led care. 3. Results 3.1. Characteristics of the participants Fig. 1 shows the flow of participants through the trial. Of the 110 eligible women who consented to take part in the study, 55 women were assigned routine obstetricianled care and 55 midwives’ antenatal clinic care. Two women in each group chose to give birth in other hospitals and they were lost to follow up. Three women in the intervention group and two women in the control group withdrew immediately from the study. But the delivery modes of these women were still followed up through chart review, eventually resulting in 53 participants in each group. Two women who withdrew from each group had caesarean sections and one in the intervention group had a vaginal birth. The baseline characteristics of women were similar in the two groups (Table 2). There were no differences between the two groups in women’s age, parity, education level, socioeconomic status and foetal biparietal diameter at 32 weeks gestation. In the intervention group, 47 women had their husband with them at the midwives’ antenatal clinic. And each time the woman met the midwife, her husband would also attend the clinic. All of the women in both groups received continuity of midwifery care in labour.
3.2. Childbirth outcome measures Women in the midwives’ antenatal clinic service group were less likely to have a caesarean birth compared with women in obstetrician-led care group (18 [33.96%] versus 30 [56.60%]; 95% CI for difference 41.60 to 3.69) (Table 3). We found no differences between the two groups in the neonatal Apgar scores and the amount of bleeding 2 h post partum (Table 3). 3.3. Maternal psychological state and satisfaction The mean S-AI scores at intake were 36.15 8.29 in the intervention group, and 37.75 9.39 in the control group, making no significant differences between the two groups (P > 0.05; 95% CI 5.02 to 1.81). Women’s mean S-AI scores when they were on admission to LDR were 38.73 10.10 in the intervention group and 46.09 8.96 in the control group, respectively, giving significant differences between the two groups (P < 0.001; 95% CI 11.25 to 3.45) (Table 4). Table 4 also shows that women in the intervention group expressed greater satisfaction with perinatal experiences (95% CI 0.65–1.40; P < 0.001) and greater satisfaction with antenatal clinic care (P < 0.05) than women in the routine care group. 4. Discussion This study was a pioneering trial evaluating the effectiveness of midwives’ antenatal clinic service model in China. And it was delivered in an obstetrician-led setting, which inevitably affects practice and therefore the findings. The fact that provision of similar service within other settings may yield different results should be borne in mind when the findings are applied elsewhere. A limitation of the study was the absence of midwifery care in the first two trimesters of pregnancy. Midwifery care was only provided in the last trimester of pregnancy (after 28 weeks gestation). This was due to lack of more midwifery resources. However, this study expanded Chinese midwives’ former working scope and it was an extension of our previous study in which midwives were
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Table 3 Maternal and infant outcomes.
Number (%) with mode of delivery Caesarean section Vaginal birth Mean (SD) blood loss 2 h post partum Neonatal Apgar score, n (%) 8–10 at 1 min 8–10 at 5 min a
Intervention group (n = 53)
Control group (n = 53)
Difference (95% CI)
P value
18 (33.96%) 35 (66.04%) 179.34 (34.92)
30 (56.60%) 23 (43.40%) 188.21 (60.92)
22.64% ( 41.60 to 3.69) 22.64% (3.69–41.60) 8.87 ( 27.99 to 10.26)
0.019a
50 (94.34%) 53 (100%)
51 (96.23%) 52 (98.11%)
1.89% ( 39.05 to 35.28) 1.89% ( 36.01 to 39.78)
0.921 0.922
0.360
x2 test.
only confined to the labour and delivery unit. Another limitation of our study was the absence and difficulty of blinding. Our study examined the efficacy of midwives’ antenatal clinic service, women’s psychological state and satisfaction with such care model. While the sample size was small, the results suggested that this is a beneficial model of antenatal care that has the potential to be implemented and evaluated more widely in China. Differences between midwifery and other models of care often include variations in philosophy, focus, relationship between the care provider and the pregnant woman (Sandall et al., 2009), and in the goals and objectives of care (Rooks, 1999). The midwives’ antenatal clinic service in this study just upheld the philosophy that pregnancy and birth are normal physiological life events; emphasised midwives’ continuity of care during the antenatal period, and focussed on the woman-midwife relationship, the provision of consistent advice and information, which was rarely mentioned elsewhere in China but had been extensively used in developed countries (Johnson et al., 2003; Cooke et al., 2004; Sandall et al., 2009). We found in our study that compared with routine obstetrician-led antenatal care, the midwives’ antenatal clinic service resulted in a reduced caesarean section rate, increased vaginal birth rate, and greater satisfaction with care, which was in keeping with findings from the studies of Homer et al. (2001), Johnson et al. (2005), Kuo et al. (2010), Williams et al. (2010) and McLachlan et al. (2012). The original hypothesis was therefore supported. However, differences in caesarean section rates have not been found in some trials of midwifery care (Hatem et al., 2008; Waldenstrom and Turnbull, 1998), which is in contrast to our primary finding. It is uncertain what component of the
midwives’ clinic care model in our study caused the reduction of the caesarean section rate. But the two trials of 2314 and 1089 women, respectively, also demonstrated significant differences (Homer et al., 2001; McLachlan et al., 2012). Meanwhile, our study showed that the caesarean section rate was 33.96% in the intervention group and 56.60% in the control group. As the general hospital caesarean section rate in 2009 was 70%, it can be seen that the rates in both groups were reduced to different degrees. In addition, 50% women who received continuity of labour care in our previous study (Gu et al., 2011) had caesarean sections, which was similar to those in the control group in our present study. The fact that women in the obstetricianled antenatal care group received continuity of labour care might possibly explain the reason why these women’s caesarean section rate was reduced from 70% to 56.60%. Therefore, it can be inferred that midwives’ involvement in antenatal clinic and continuity of labour care is of crucial importance in the process of providing midwifery care. The greatest differences between the two groups were in antenatal and intrapartum care. Women in the intervention group always had a named midwife who aimed to provide the majority of care in the late trimester and during labour, whereas women in the routine care group received care from several different people including obstetricians and nurses. Homer et al. (2002) also noted that women who had a known midwife during labour had a significantly higher sense of ‘control’ and a more positive birth experience compared with women who reported an unknown midwife. According to Devane et al. (2007), encouragement, assistance and advice were essential elements in providing midwifery care. Midwives in our study had just made full
Table 4 Maternal anxiety level and satisfaction with maternity care. Intervention group (n = 53) Mean (SD) scores of C-STAI-S On admission to groups (53/53)a 36.15 (8.29) On admission to LDR (49/46)a 38.73 (10.10) Satisfaction with perinatal care experience (scores), (44/40)a Mean (SD) 9.00 (0.75) Satisfaction with antenatal clinic care service (44/40)a, n (%) Strongly satisfied/satisfied 31 (70.5%) Not sure 12 (27.3%) Strong-dissatisfied/dissatisfied 1 (2.3%) a b
Control group (n = 53) 37.75 (9.39) 46.09 (8.96) 7.98 (0.95) 15 (37.5%) 20 (50.0%) 5 (12.5%)
Difference (95% CI) 1.6 ( 5.02 to 1.81) 7.35 ( 11.25 to 3.45)
P value 0.353 0.000
1.02 (0.65–1.40)
0.000
x2 = 10.06
0.007b
Numbers in parentheses indicate number for whom this information was available (intervention group/control group). x2 test.
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use of these key points and developed a close rapport with the woman since the late trimester of pregnancy. With the aim of facilitating more choice, continuity and control for women, midwives in the intervention group were in partnership with the woman, responsible for assessment of her care needs, making individualised care plans for her, and also gaining interaction with the woman, which might be the reason why more women in the intervention group chose to give birth vaginally than those in the control group. Concurrently, for variables for which we set out to test equivalence (e.g., amount of vaginal bleeding and neonatal Apgar score), we found no statistically significant differences, which indicated that the midwives’ antenatal clinic service model did not adversely affect these variables, or further investigations are still required due to the smaller sample size in our study. As Hildingsson and Radestad (2005) have pointed out, psychosocial aspects of care, information and caregiver support are factors associated with antenatal satisfaction; while inappropriate time allocated to antenatal check-ups and lack of support from midwives are identified as sources of dissatisfaction. We found in our study that women receiving the midwives’ antenatal clinic service reported greater satisfaction with antenatal care and their perinatal experiences than those receiving routine care. Similar to other studies of midwifery care (Hodnett, 2001; Shields et al., 1998), women were more highly satisfied in relationships with midwives, information transfer, choices and decisions, and more pleased with midwives’ providing antenatal and intrapartum care (Villar et al., 2001). However, we acknowledge that the response rate of our satisfaction questionnaire was only 83.2%, which was also a weakness in our study. On the one hand, midwives’ professional instruction in the intervention group could help women be well prepared for labour and birth, and get command of breathing techniques and other coping methods. On the other hand, the midwife and the woman always had plenty of topics to discuss and consulting time each time they met. The woman could keep in contact with the midwife to receive individualised continuity of care during the perinatal period, thus creating a more relaxed atmosphere. This is in agreement with Page et al. (2000)’s statement that continuity of care and carer are important determinants of a positive childbirth experience. The women in the intervention group were always in good partnership with their midwife. They felt that their expectations with care had been fulfilled and had positively responded to the partnership midwifery practice, which is supported by Johnson et al.’s (2003) study. Additionally, we found in this study that women’s S-AI scores between the two groups had no significant differences at intake. However, women in the routine care group had much higher S-AI scores than those in the intervention group when admitted to LDR, which indicated that the midwives’ antenatal clinic service could lower maternal anxiety to some degree, while women in the routine obstetrician-led care group became more anxious with the increase in their gestational age. As Cheung et al. (2007) noted in their study, there was a significant
negative relationship between maternal anxiety and feelings of control during labour. Gibbins and Thomson (2001) also pointed out that maternal feelings of control during labour might help in decreasing the level of anxiety during pregnancy. Support from midwives was one of the effective methods to reduce the level of maternal anxiety (Halldorsdottir and Karlsdottir, 1996). In our study, expectant fathers were encouraged to attend the midwives’ antenatal clinic and give the woman adequate and effective support, thus helping the woman gain positive experiences during the perinatal period, which is supported by other studies (Hildingsson and Radestad, 2005; Sercekus and Mete, 2010). Consequently, the creation of a trusting relationship between the midwife, the woman and her partner is particularly important to improve the pregnancy and childbirth experiences. We consider this as the premise to successfully implement our new model of midwifery care.
5. Conclusion and implications for practice A new Chinese midwives’ antenatal clinic care model was implemented in this study, using a randomised controlled trial design to explore its effect on childbirth outcomes, psychological state and satisfaction, for primiparae. We conclude that the midwives’ antenatal clinic service is clinically efficacious, which has decreased the rate of caesarean section and enhanced Chinese women’s satisfaction with midwifery care. Accordingly, we consider this model as a new approach for Chinese midwives to provide continuity of care for pregnant and labouring women, and to expand midwives’ working scopes and job roles. Only in this way can the Chinese midwives keep up with the international trends and developments in midwifery. And we will attempt to make midwifery care a true choice for Chinese women. However, midwives’ competences and their education levels still need to be developed and evaluated if we implement this model of care more widely in China. Variables such as the rates of antenatal hospitalisation, episiotomy, intrapartum analgesia and breastfeeding, need to be further explored. Our future efforts will be focussed on the midwives’ involvement in the entire perinatal period by acquiring more midwifery resources. Conflict of interest: None declared. Funding: The Nursing School of Fudan University Fund supported the research and governed the progress and review of this study (No. FNF201004). Ethical approval: Ethical approval was obtained from the Obstetrics and Gynaecology Hospital Ethics Committee of Fudan University (OGHEC[2010]28). Acknowledgements This study was supported by the Nursing School of Fudan University, Shanghai, China. The authors would like to thank the women who participated in our study and pay tribute to the midwife trainers and hospitals for supporting this project. We would also like to express our thanks to all
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