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Home based educational intervention to improve perinatal outcomes for a disadvantaged community: A randomised control trial
European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 162–167
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European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Home based educational intervention to improve perinatal outcomes for a disadvantaged community: A randomised control trial Orla Doyle a, *, Edel McGlanaghy b , Eylin Palamaro-Munsell b , F.M. McAuliffe c a
UCD School of Economics & UCD Geary Institute, University College Dublin, Ireland UCD Geary Institute, University College Dublin, Ireland c UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 October 2013 Received in revised form 27 May 2014 Accepted 13 June 2014
Objectives: Pregnancy, labour, and delivery involve risk for mothers and infants. This study tested the effectiveness of a home-based programme to improve perinatal outcomes among socially disadvantaged women. The hypothesis was that the intervention group who received education and support during pregnancy would have better perinatal outcomes than the control group. Study design: This is a randomised controlled trial. Pregnant women from a disadvantaged community in Dublin, Ireland were eligible for participation in Preparing for Life, a home visiting early intervention programme. 233 participants were recruited and assigned to an intervention (n = 115) and control (n = 118) group using an unconditional probability randomisation strategy. Maternity hospital records were available for 206 participants (nintervention = 106; ncontrol = 100). Consent to access records was not provided by 9 participants, records were missing for 17 participants and 1 record was excluded due to miscarriage. The intervention group were prescribed an average of ten prenatal home visits from a trained mentor. Mentors provided information on healthy prenatal behaviours and the birthing experience using tip sheets and social support. The control group received care as usual including the opportunity to attend standard antenatal classes. The outcomes included neonatal (Apgar scores, birth weight, gestational age and prematurity) and maternal (labour onset method and delivery method) outcomes. Statistical analyses were conducted using t -tests, tests of proportions, regression, logistic regression and permutation testing. Results: There were no differences on any of the neonatal outcomes or the majority of the maternal outcomes. Two secondary results were found such that there was an increase in the rate of spontaneous onset of labour in the intervention group compared to the control group (69.8% v 58.0%; OR 1.67, 95% CI = 0.94, 2.97; p < 0.05) and there was a reduction in caesarean section rates in the intervention group compared to the control group (15.1% v 25.0%; OR 0.53, 95% CI = 0.27, 1.07; p < 0.05). Conclusions: This prenatal home visiting programme had no impact on neonatal outcomes, yet there was suggestive evidence that it prepared women for birth, and potentially led to increased spontaneous onset of labour and reduced caesarean section. Further studies are required to test these observation generating hypotheses. Trial registration ISRCTN04631728- http://www.controlled-trials.com/ISRCTN04631728/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Home visiting programme Randomised control trial Neonatal outcomes Maternal outcomes
Introduction Pregnancy and birth pose risks to both mother and infant [1]. Maternal behaviour during pregnancy, such as substance use and
* Corresponding author. Tel. : +353 17164637. E-mail address: [email protected] (O. Doyle). http://dx.doi.org/10.1016/j.ejogrb.2014.06.006 0301-2115/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
poor nutrition, can increase the likelihood of pregnancy complications leading to infant prematurity and low birth weight [2] which can have life-long effects on children’s development [3]. Such adverse pregnancy behaviours are typically more prevalent among socioeconomic disadvantaged mothers [4,5] who are less likely to participate in antenatal services which educate women about pregnancy and labour. [6] While the findings on the effectiveness of antenatal education are mixed [7], pregnancy
O. Doyle et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 162–167
complications are more common for those with no antenatal care; and low or no attendance at antenatal services is associated with low birth weight and perinatal death [8]. Home visiting programmes provided in the prenatal period to high risk women have been proposed as a means of addressing poor attendance at antenatal services and promoting maternal and infant health [9]. While home visiting programmes have demonstrated improvements in child and maternal postnatal outcomes [10], few studies report the effects on neonatal outcomes and fewer still report their impact on maternal labour outcomes. A review of 28 prenatal home visiting programmes found little evidence of improvements in neonatal outcomes such as birth weight and gestational age [11]. Those limited studies that have reported on maternal labour outcomes identified no effect on labour onset or mode of delivery. One study reported a trend of more spontaneous onset of labour and vaginal deliveries in a sample of socially disadvantaged women [12]. This study used a randomised controlled trial (RCT) to assess the impact of the Preparing for Life (PFL) home visiting programme on neonatal and maternal outcomes for infants and mothers from a socially disadvantaged community. The hypothesis was that the intervention group who had received education and support via home visits during pregnancy would have better perinatal outcomes than the control group. Methods This is a randomised controlled trial with institutional ethical approval and maternal written consent prior to randomisation. Participants received a s20 shopping voucher for completing the interviews. Full details of the trial and study design are published elsewhere [13] and briefly described here. Participants The PFL recruitment officer enrolled pregnant women from a community in Dublin, Ireland, which had above national average rates of unemployment, early school leavers, lone parent households and social housing. All pregnant women from this community were eligible to participate. Participation was voluntary and recruitment took place between 2008 and 2010 through two maternity hospitals at the first antenatal visit or self-referral in the community. The population-based recruitment rate was 52% of all live births. On average, participants were 21.5 weeks pregnant at recruitment (Mintervention = 21.7, SDintervention = 7.5; Mcontrol = 21.2, SDcontrol = 7.0).
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community level. It was grounded in theories of human attachment, socio-ecological development, and social-learning. PFL involved bi-monthly home visits lasting approximately one hour. These were provided by trained mentors from a range of professional backgrounds including education, psychology, and childcare. All mentors received extensive training and weekly supervision. Each family was assigned the same mentor over the course of the intervention. This study refers to the impact of the intervention between programme entry and childbirth. During home visits, mentors reviewed pre-birth and pregnancy information using a set of tip sheets which included topics on preparation for birth, social support, substance use and healthy eating. Mentors also provided support to participants and addressed anxieties or concerns around pregnancy. The control group did not receive home visits, however, they were contacted once by the PFL programme office and were offered widely available pregnancy leaflets. In addition, they could avail of standard antenatal education classes in the maternity hospital. More information on PFL may be found in the programme manual and short informational films available here www.preparingforlife.ie/. Implementation PFL prescribed an average of ten prenatal home visits, however only 60% of these visits were delivered. This is consistent with the home visiting literature which reports that approximately half of all prescribed visits are not received [14]. On average, the intervention group received six visits between programme entry and birth, with each lasting 56 min on average. Few participant characteristics were associated with the frequency or duration of visits, suggesting that differential dosage was random [15]. Given the geographical proximity of participants in the intervention and control groups, a number of strategies were devised to measure information flows which may have resulted in contamination. While the conditions for contamination were high, participant interaction did not translate into improved parenting knowledge among the control group [15]. Data collection and outcomes
An unconditional probability randomisation procedure assigned 115 participants to the intervention group and 118 to the control group. To ensure randomisation was not compromised each participant clicked on the randomisation website where she was automatically assigned a number which corresponded to her treatment assignment. This process generated an automatic email with her assignment condition and identification code. If there were any attempts to reassign participants by repeating the randomisation procedure, a second email would automatically highlight this intentional subversion. This ensured that participants could not be reassigned once randomised. The intervention and control groups were not blinded to their treatment assignment.
Baseline data was collected in the participants’ homes by researchers who were blind to the treatment condition. Tests of baseline differences between the intervention and control groups found that they did not statistically differ on 97% of the 123 measures analysed [13]. Participants’ infants were born between 2008 and 2011. Fig. 1 illustrates the trial profile. Of the 233 participants recruited, 224 consented for their files to be accessed (Nintervention = 113, Ncontrol = 111). Files were not available in the hospital for 17 participants (Nintervention = 6, Ncontrol = 11), and 1 participant was not included in the analysis due to miscarriage (Nintervention = 1, Ncontrol = 0). The final estimation sample was 206 (Nintervention = 106, Ncontrol = 100) participants who gave birth to 208 infants (including 2 sets of twins). Baseline data was available for 188 of these participants as 18 did not complete the baseline assessment. The study considered two sets of outcomes, neonatal outcomes including Apgar cutoff scores (<7), birth weight, gestational age and prematurity, and maternal outcome including labour onset and mode of delivery (caesarean section, emergency caesarean section, elective caesarean section, and other forms of instrumental delivery).
Procedure
Statistical analysis
The intervention consisted of the PFL programme which was a non-clinical intervention developed and delivered at the
An intention-to-treat analysis was conducted. The methodological strategy pre-specified two stages of analysis. First, t -tests
Randomisation and masking
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Enrolment
Eligible (n=447), recruited (n=233). Population based recruitment rate = 52%
Randomized (n= 233)
Allocation
Number of home visits received 0 1 2 3 4 5 6 7 8 9 10 11 12 13 15 16 17 21
n=23 n=12 n=6 n=4 n=10 n=11 n=7 n=7 n=8 n=8 n=6 n=2 n=5 n=1 n=1 n=2 n=1 n=1
Allocated to intervention (n= 115)
Allocated to control (n= 118)
Consent declined for access to maternity records (n=2)
Consent declined for access to maternity records (n=7)
Follow-Up
Maternity records not identified (n=6)
Maternity records not identified (n=11)
Excluded from analysis due to miscarriage (n=1)
Excluded from analysis due to miscarriage (n=0)
Analysis Analysed (n= 100)
Analysed (n=106)
Fig. 1. Trial profile.
for continuous outcomes and tests of proportions for binary outcomes were estimated to test for differences by treatment status. One-tailed (right sided) p values were reported. Second, ordinary least squares regression for continuous outcomes and logistic regression for binary outcomes were estimated to test for differences by treatment status while controlling for parity and incidence of previous caesarean section (i.e., the adjusted model). In all cases, permutation testing (with 100,000 replications) was also conducted to test for differences [16]. The results from these tests were similar to the conventional testing methods, thus the conventional results were reported here. STATA MP 12 was used for all statistical analysis.
Results Table 1 describes the composition of the intervention and control groups at baseline regarding demographic, health and pregnancy characteristics. Table 2 presents the unadjusted and adjusted one-tailed tests comparing neonatal and maternal outcomes of the intervention and control groups. There were no statistically significant differences for the majority of the neonatal outcomes including birth weight, gestational age, prematurity and low Apgar cutoff scores at 5 min. The adjusted model showed that infants in the intervention group were less likely to be within the low Apgar cutoff at 1 min
Table 1 Baseline characteristics at recruitment for intervention and control groups. N (nintervention /ncontrol)
Intervention
Control
Demographic factors Age at birth Married Number of household members Third level educational degree Employed Living in social housing Equivalised weekly household income s
205 (105/100) 188 (99/89) 188 (99/89) 188 (99/89) 188 (99/89) 188 (99/89) 150 (78/72)
25.79 (5.8) 14 (14%) 3.56 (1.8) 3 (3%) 37 (37%) 54 (55%) 260 (120)
26.02 (6.0) 14 (16%) 3.60 (2.0) 3 (3%) 39 (44%) 48 (54%) 295 (168)
Health and pregnancy factors Multiparous Previous caesarean section Scores below WHO-5 well-being index cutoff BMI Weeks of gestation at programme entry
206 (106/100) 206 (106/100) 186 (97/89) 182 (95/87) 188 (99/89)
48 (45%) 10 (9%) 43 (44%) 25.94 (5.6) 21.68 (7.5)
51 (51%) 14 (14%) 33 (37%) 25.88 (4.7) 21.21 (7.0)
Notes: ‘N’ indicates the sample size. Values are given as number and percentage or mean standard deviation as indicated.
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Table 2 Comparison of perinatal outcomes for intervention and control groups. N (nintervention /ncontrol) Neonatal outcomes Birth weight (grams) Gestational age at birth (weeks) Prematurity (<37 weeks gestation) Apgar 1 min (<7) Apgar 5 min* (<7) Maternal outcomes Spontaneous onset of labour Caesarean section (any) Emergency caesarean section Elective caesarean section Instrumental delivery (not including caesarean)
Intervention
Control
Unadjusted
Adjusted
Odds ratio (95% CI)
P-value**
Odds ratio (95% CI)
P-value***
208 202 202 206 206
(108/100) (106/96) (106/96) (108/98) (108/98)
3302 631 39.69 2.41 8 (7.5%) 5 (4.6%) 1(1.0%)
3268 617 39.49 2.06 7 (7.3%) 10 (10.2%) 0 (0.0%)
– – 1.04 (0.36; 2.98) 0.43 (0.14; 1.30) –
0.349 0.265 0.473 0.067 –
– – 1.01 (0.35; 2.91) 0.38 (0.13; 1.18) –
0.305 0.261 0.491 0.048 –
206 206 206 206 206
(106/100) (106/100) (106/100) (106/100) (106/100)
74 (69.8%) 16 (15.1%) 8 (7.5%) 8 (7.5%) 20 (18.9%)
58 (58.0%) 25 (25.0%) 13 (13.0%) 12 (12.0%) 21 (21.0%)
1.67 (0.94; 2.97) 0.53 (0.27; 1.07) 0.55 (0.22; 1.38) 0.60 (0.23; 1.53) 0.87 (0.44; 1.73)
0.039 0.039 0.101 0.143 0.351
1.69 (0.95; 3.02) 0.55 (0.27; 1.12) 0.51 (0.20; 1.32) 0.67 (0.25; 1.76) 0.78 (0.38; 1.61)
0.037 0.049 0.084 0.206 0.250
Notes: ‘N’ indicates the sample size. Values are given as number and percentage or mean standard deviation as indicated. * Odds ratios and p-values for Apgar 5 min measure could not be presented as none of the intervention sample met the cutoff. ** One-tailed (right-sided) p value from a t test for continuous outcomes and a test of proportions for binary outcomes. *** One-tailed (right sided) p value from an OLS regression for continuous outcomes and logistic regression for binary outcomes controlling for parity and incidence of previous caesarean section.
compared to the control group; however this result was only a trend in the unadjusted model. Two significant differences were observed for maternal outcomes. In both the unadjusted and adjusted models, the intervention group were more likely to have experienced spontaneous onset of labour compared to the control group. In addition, women in the intervention group were less likely to have a caesarean section than those in the control group. This result was significant in the adjusted and unadjusted models. There were no significant differences regarding emergency and elective caesarean sections; however there was a trend in the adjusted model for emergency caesarean sections. There was no difference for other forms of instrumental delivery. Other variables tested but not presented, including low birth weight, high birth weight and small for gestational age, were also not significant. Comment This study found that prenatal home visits provided to socioeconomic disadvantaged women had no impact on neonatal outcomes or the majority of maternal outcomes, however there was suggestive evidence that it resulted in increased spontaneous onset of labour and a lower caesarean section rate. These findings are in line with well-documented evidence of a relationship between spontaneous labour onset and caesarean section. However, the nature of this relationship is subject to conflicting findings, with observational studies typically identifying a positive relationship between labour induction and caesarean section, [17,18] and experimental studies identifying no effect or a negative relationship [19]. The findings reported here suggest that the intervention may have had an effect on the birthing process. The concurrent increase in spontaneous onset of labour and reduction in caesarean sections suggests that the intervention group displayed less risk indicators that required intervention. A comparison of this sample to maternity outcomes in Ireland [20,21] shows accordance with the national rates regarding gestational age and prematurity. However average birth weight was lower among the study sample which was to be expected given their disadvantaged status [4]. The lack of effects on neonatal outcomes may be attributed to the timing and intensity of programme visits. On average, participants joined the programme during the 22nd week of pregnancy. Thus, efforts to modify mother’s behaviour, such as substance use and eating habits, may
have been delivered too late to significantly impact birth weight and gestational age [22]. These results are consistent with reviews of other home visiting programmes [11,23]. These findings may also be related to insufficient programme intensity. As noted, dosage was lower than intended. This is a significant issue as increased frequency of home visits is associated with improved child outcomes [10]. Given that the home visiting model is based on building relationships of trust between participants and mentors, there should be sufficient time invested in that relationship and adequate exposure to programme materials in order to generate behavioural change. Regarding maternal outcomes, 57% of all deliveries conducted in Ireland in 2010 were spontaneous in onset and 26% of all live births were delivered by caesarean section [20,21]. While these rates are consistent with those experienced by the control group, the intervention group had significantly higher rates of spontaneous onset of labour and lower rates of caesarean section at 70% and 15% respectively. While one must be cautious about attributing these results to the programme, the findings that the intervention group differed from the national average suggests that the programme may have provided benefits above the standard antenatal classes offered in maternity hospitals. The potential impact of the intervention on maternal outcomes may be attributed to the prenatal visits which focused on preparing the mother for the birthing process. The intervention may have served to reduce anxiety around childbirth and increase awareness of labour, however this is a hypothesis which requires further testing. A review of the literature on anxiety and obstetric complications suggests that specific types of anxiety such as psychosocial stress, family functioning and fear of childbirth may increase the likelihood of birth complications [24]. For example, fear of childbirth increases the likelihood of emergency caesarean section, [25] and psychosocial interventions targeting women who request caesarean sections due to fear of childbirth have resulted in less instrumental deliveries [26]. A review found mixed evidence of the impact of anxiety on caesarean sections [27]. The mechanism proposed to explain this relationship is hormone regulation, however support for this hypothesis is mixed [25]. While the sample size precluded us from identifying whether the caesarean effect was concentrated among emergency or elective caesarean sections, the proportion of both procedures was lower in the intervention group. While the choice to have a caesarean section is often made by the obstetrician, maternal preference may play a role in her acceptance of intervention [28].
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Strengths and limitations The study has some limitations. The results are based on one home visiting programme operating in a specific community, and thus may not generalize to other communities or programmes. The sample size employed was relatively small. Yet when data were re-estimated using permutation-based hypothesis [16] testing accommodate to the small sample size, similar results were obtained. Another limitation is that we could not explore the mechanisms underlying the potential effect on maternal outcomes. Although maternal anxiety was measured at baseline, it was not captured at the time of delivery. Thus we cannot observe whether there was a reduction in anxiety during pregnancy which may have affected outcomes. This study has a number of strengths. Robust efforts were made to design a randomisation procedure which preserved the integrity of the experiment. In addition, while the participants were not blind to the treatment condition, hospital staff were blinded. A comparison of the baseline characteristics of the sample found no differences between the intervention and control group suggesting that the sample was balanced. Another significant strength of the study was the efforts to measure contamination. As little evidence of contamination was found, it suggests that the effects may be attributed to the programme [15]. Finally, the majority of studies in this field are restricted to North American data and there is a clear lack of research on the effects of home visiting programmes in European countries with different social and cultural contexts. Conclusion This prenatal home visiting programme had no impact on neonatal outcomes, yet there was suggestive evidence that it prepared women for birth, and potentially reduced the rates of caesarean section and increased the incidence of spontaneous labour. Further studies are required to test these observation generating hypotheses. Obstetric techniques such as caesarean section can be lifesaving, however increases in these procedures has led to concern regarding their overuse particularly in high income countries [29]. Caesarean section, especially those that are not medical justified, include a risk of maternal morbidity and mortality [30], as well as a risk of physical, emotional, and reproductive consequences for the mother and negative health outcomes for the child [31]. The growing rate of caesarean sections also has financial implications as the average cost of elective caesarean section is between 27–63% higher than vaginal delivery [32]. While a greater number of caesarean sections are performed in medium and high income countries, evidence suggests that the correlation between increasing caesarean rates and declining neonatal and maternal mortality is restricted to low income countries [33]. In particular, there is no associated between caesarean section and infant and maternal mortality rates in countries with caesarean section rates of above 15% [34]. That the proportion of caesarean sections in this study’s intervention group was in line with the WHO’s recommendation of an upper limit of 15% [35] is thus significant. While studies of prenatal home visiting programmes have focused on neonatal outcomes, few have examined the potential effects on maternal labour outcomes. The findings presented here suggest that such analysis may prove informative as identifying interventions which improve maternal outcomes in high income countries is significant from both a clinical and financial perspective. Conflict of interest The trial was funded by the Northside Partnership through funding provided by The Atlantic Philanthropies and the
Department of Children and Youth Affairs. The Northside Partnership manages the Preparing for Life programme and funds the evaluation of the programme. Role of funding source The funder had no involvement in the conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The funder had involvement in the original design of the trial.
Contribution to authorship OD designed the study. EMG and EPM contributed to planning the study and data collection. OD and EMG did the primary data analysis. EPM and FMA contributed to supplementary analyses. OD and EMG wrote the report. All authors contributed to the interpretation of the data. All authors approved the final version. OD is guarantor.
Ethics approval The study was approved by the UCD Human Research Ethics Committee, 8 May 2008, ref: HS-07–26-Harmon–Doyle; The Rotunda Hospital Ethic Committee, 12 May 2008; and the National Maternity Hospital Ethics Committee, 28 July 2008. All participants gave informed consent before taking part in the randomisation process. Acknowledgements We thank all those who participated and supported the research, especially the PFL participants, PFL intervention staff, UCD field staff, local community organisations, the Scientific Advisory Team (Professor Colm Harmon, Professor James Heckman, Professor Cecily Kelleher, Professor Sharon Ramey, Professor Sylvana Cote, and Professor Richard Tremblay), and the Expert Advisory Committee (Professor Mark Dynarski and Professor Marjorie Smith) for their support and guidance in this work.
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Home based educational intervention to improve perinatal outcomes for a disadvantaged community: A randomised control trial Orla Doyle a, *, Edel McGlanaghy b , Eylin Palamaro-Munsell b , F.M. McAuliffe c a
UCD School of Economics & UCD Geary Institute, University College Dublin, Ireland UCD Geary Institute, University College Dublin, Ireland c UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 October 2013 Received in revised form 27 May 2014 Accepted 13 June 2014
Objectives: Pregnancy, labour, and delivery involve risk for mothers and infants. This study tested the effectiveness of a home-based programme to improve perinatal outcomes among socially disadvantaged women. The hypothesis was that the intervention group who received education and support during pregnancy would have better perinatal outcomes than the control group. Study design: This is a randomised controlled trial. Pregnant women from a disadvantaged community in Dublin, Ireland were eligible for participation in Preparing for Life, a home visiting early intervention programme. 233 participants were recruited and assigned to an intervention (n = 115) and control (n = 118) group using an unconditional probability randomisation strategy. Maternity hospital records were available for 206 participants (nintervention = 106; ncontrol = 100). Consent to access records was not provided by 9 participants, records were missing for 17 participants and 1 record was excluded due to miscarriage. The intervention group were prescribed an average of ten prenatal home visits from a trained mentor. Mentors provided information on healthy prenatal behaviours and the birthing experience using tip sheets and social support. The control group received care as usual including the opportunity to attend standard antenatal classes. The outcomes included neonatal (Apgar scores, birth weight, gestational age and prematurity) and maternal (labour onset method and delivery method) outcomes. Statistical analyses were conducted using t -tests, tests of proportions, regression, logistic regression and permutation testing. Results: There were no differences on any of the neonatal outcomes or the majority of the maternal outcomes. Two secondary results were found such that there was an increase in the rate of spontaneous onset of labour in the intervention group compared to the control group (69.8% v 58.0%; OR 1.67, 95% CI = 0.94, 2.97; p < 0.05) and there was a reduction in caesarean section rates in the intervention group compared to the control group (15.1% v 25.0%; OR 0.53, 95% CI = 0.27, 1.07; p < 0.05). Conclusions: This prenatal home visiting programme had no impact on neonatal outcomes, yet there was suggestive evidence that it prepared women for birth, and potentially led to increased spontaneous onset of labour and reduced caesarean section. Further studies are required to test these observation generating hypotheses. Trial registration ISRCTN04631728- http://www.controlled-trials.com/ISRCTN04631728/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Home visiting programme Randomised control trial Neonatal outcomes Maternal outcomes
Introduction Pregnancy and birth pose risks to both mother and infant [1]. Maternal behaviour during pregnancy, such as substance use and
* Corresponding author. Tel. : +353 17164637. E-mail address: [email protected] (O. Doyle). http://dx.doi.org/10.1016/j.ejogrb.2014.06.006 0301-2115/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
poor nutrition, can increase the likelihood of pregnancy complications leading to infant prematurity and low birth weight [2] which can have life-long effects on children’s development [3]. Such adverse pregnancy behaviours are typically more prevalent among socioeconomic disadvantaged mothers [4,5] who are less likely to participate in antenatal services which educate women about pregnancy and labour. [6] While the findings on the effectiveness of antenatal education are mixed [7], pregnancy
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complications are more common for those with no antenatal care; and low or no attendance at antenatal services is associated with low birth weight and perinatal death [8]. Home visiting programmes provided in the prenatal period to high risk women have been proposed as a means of addressing poor attendance at antenatal services and promoting maternal and infant health [9]. While home visiting programmes have demonstrated improvements in child and maternal postnatal outcomes [10], few studies report the effects on neonatal outcomes and fewer still report their impact on maternal labour outcomes. A review of 28 prenatal home visiting programmes found little evidence of improvements in neonatal outcomes such as birth weight and gestational age [11]. Those limited studies that have reported on maternal labour outcomes identified no effect on labour onset or mode of delivery. One study reported a trend of more spontaneous onset of labour and vaginal deliveries in a sample of socially disadvantaged women [12]. This study used a randomised controlled trial (RCT) to assess the impact of the Preparing for Life (PFL) home visiting programme on neonatal and maternal outcomes for infants and mothers from a socially disadvantaged community. The hypothesis was that the intervention group who had received education and support via home visits during pregnancy would have better perinatal outcomes than the control group. Methods This is a randomised controlled trial with institutional ethical approval and maternal written consent prior to randomisation. Participants received a s20 shopping voucher for completing the interviews. Full details of the trial and study design are published elsewhere [13] and briefly described here. Participants The PFL recruitment officer enrolled pregnant women from a community in Dublin, Ireland, which had above national average rates of unemployment, early school leavers, lone parent households and social housing. All pregnant women from this community were eligible to participate. Participation was voluntary and recruitment took place between 2008 and 2010 through two maternity hospitals at the first antenatal visit or self-referral in the community. The population-based recruitment rate was 52% of all live births. On average, participants were 21.5 weeks pregnant at recruitment (Mintervention = 21.7, SDintervention = 7.5; Mcontrol = 21.2, SDcontrol = 7.0).
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community level. It was grounded in theories of human attachment, socio-ecological development, and social-learning. PFL involved bi-monthly home visits lasting approximately one hour. These were provided by trained mentors from a range of professional backgrounds including education, psychology, and childcare. All mentors received extensive training and weekly supervision. Each family was assigned the same mentor over the course of the intervention. This study refers to the impact of the intervention between programme entry and childbirth. During home visits, mentors reviewed pre-birth and pregnancy information using a set of tip sheets which included topics on preparation for birth, social support, substance use and healthy eating. Mentors also provided support to participants and addressed anxieties or concerns around pregnancy. The control group did not receive home visits, however, they were contacted once by the PFL programme office and were offered widely available pregnancy leaflets. In addition, they could avail of standard antenatal education classes in the maternity hospital. More information on PFL may be found in the programme manual and short informational films available here www.preparingforlife.ie/. Implementation PFL prescribed an average of ten prenatal home visits, however only 60% of these visits were delivered. This is consistent with the home visiting literature which reports that approximately half of all prescribed visits are not received [14]. On average, the intervention group received six visits between programme entry and birth, with each lasting 56 min on average. Few participant characteristics were associated with the frequency or duration of visits, suggesting that differential dosage was random [15]. Given the geographical proximity of participants in the intervention and control groups, a number of strategies were devised to measure information flows which may have resulted in contamination. While the conditions for contamination were high, participant interaction did not translate into improved parenting knowledge among the control group [15]. Data collection and outcomes
An unconditional probability randomisation procedure assigned 115 participants to the intervention group and 118 to the control group. To ensure randomisation was not compromised each participant clicked on the randomisation website where she was automatically assigned a number which corresponded to her treatment assignment. This process generated an automatic email with her assignment condition and identification code. If there were any attempts to reassign participants by repeating the randomisation procedure, a second email would automatically highlight this intentional subversion. This ensured that participants could not be reassigned once randomised. The intervention and control groups were not blinded to their treatment assignment.
Baseline data was collected in the participants’ homes by researchers who were blind to the treatment condition. Tests of baseline differences between the intervention and control groups found that they did not statistically differ on 97% of the 123 measures analysed [13]. Participants’ infants were born between 2008 and 2011. Fig. 1 illustrates the trial profile. Of the 233 participants recruited, 224 consented for their files to be accessed (Nintervention = 113, Ncontrol = 111). Files were not available in the hospital for 17 participants (Nintervention = 6, Ncontrol = 11), and 1 participant was not included in the analysis due to miscarriage (Nintervention = 1, Ncontrol = 0). The final estimation sample was 206 (Nintervention = 106, Ncontrol = 100) participants who gave birth to 208 infants (including 2 sets of twins). Baseline data was available for 188 of these participants as 18 did not complete the baseline assessment. The study considered two sets of outcomes, neonatal outcomes including Apgar cutoff scores (<7), birth weight, gestational age and prematurity, and maternal outcome including labour onset and mode of delivery (caesarean section, emergency caesarean section, elective caesarean section, and other forms of instrumental delivery).
Procedure
Statistical analysis
The intervention consisted of the PFL programme which was a non-clinical intervention developed and delivered at the
An intention-to-treat analysis was conducted. The methodological strategy pre-specified two stages of analysis. First, t -tests
Randomisation and masking
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Enrolment
Eligible (n=447), recruited (n=233). Population based recruitment rate = 52%
Randomized (n= 233)
Allocation
Number of home visits received 0 1 2 3 4 5 6 7 8 9 10 11 12 13 15 16 17 21
n=23 n=12 n=6 n=4 n=10 n=11 n=7 n=7 n=8 n=8 n=6 n=2 n=5 n=1 n=1 n=2 n=1 n=1
Allocated to intervention (n= 115)
Allocated to control (n= 118)
Consent declined for access to maternity records (n=2)
Consent declined for access to maternity records (n=7)
Follow-Up
Maternity records not identified (n=6)
Maternity records not identified (n=11)
Excluded from analysis due to miscarriage (n=1)
Excluded from analysis due to miscarriage (n=0)
Analysis Analysed (n= 100)
Analysed (n=106)
Fig. 1. Trial profile.
for continuous outcomes and tests of proportions for binary outcomes were estimated to test for differences by treatment status. One-tailed (right sided) p values were reported. Second, ordinary least squares regression for continuous outcomes and logistic regression for binary outcomes were estimated to test for differences by treatment status while controlling for parity and incidence of previous caesarean section (i.e., the adjusted model). In all cases, permutation testing (with 100,000 replications) was also conducted to test for differences [16]. The results from these tests were similar to the conventional testing methods, thus the conventional results were reported here. STATA MP 12 was used for all statistical analysis.
Results Table 1 describes the composition of the intervention and control groups at baseline regarding demographic, health and pregnancy characteristics. Table 2 presents the unadjusted and adjusted one-tailed tests comparing neonatal and maternal outcomes of the intervention and control groups. There were no statistically significant differences for the majority of the neonatal outcomes including birth weight, gestational age, prematurity and low Apgar cutoff scores at 5 min. The adjusted model showed that infants in the intervention group were less likely to be within the low Apgar cutoff at 1 min
Table 1 Baseline characteristics at recruitment for intervention and control groups. N (nintervention /ncontrol)
Intervention
Control
Demographic factors Age at birth Married Number of household members Third level educational degree Employed Living in social housing Equivalised weekly household income s
205 (105/100) 188 (99/89) 188 (99/89) 188 (99/89) 188 (99/89) 188 (99/89) 150 (78/72)
25.79 (5.8) 14 (14%) 3.56 (1.8) 3 (3%) 37 (37%) 54 (55%) 260 (120)
26.02 (6.0) 14 (16%) 3.60 (2.0) 3 (3%) 39 (44%) 48 (54%) 295 (168)
Health and pregnancy factors Multiparous Previous caesarean section Scores below WHO-5 well-being index cutoff BMI Weeks of gestation at programme entry
206 (106/100) 206 (106/100) 186 (97/89) 182 (95/87) 188 (99/89)
48 (45%) 10 (9%) 43 (44%) 25.94 (5.6) 21.68 (7.5)
51 (51%) 14 (14%) 33 (37%) 25.88 (4.7) 21.21 (7.0)
Notes: ‘N’ indicates the sample size. Values are given as number and percentage or mean standard deviation as indicated.
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Table 2 Comparison of perinatal outcomes for intervention and control groups. N (nintervention /ncontrol) Neonatal outcomes Birth weight (grams) Gestational age at birth (weeks) Prematurity (<37 weeks gestation) Apgar 1 min (<7) Apgar 5 min* (<7) Maternal outcomes Spontaneous onset of labour Caesarean section (any) Emergency caesarean section Elective caesarean section Instrumental delivery (not including caesarean)
Intervention
Control
Unadjusted
Adjusted
Odds ratio (95% CI)
P-value**
Odds ratio (95% CI)
P-value***
208 202 202 206 206
(108/100) (106/96) (106/96) (108/98) (108/98)
3302 631 39.69 2.41 8 (7.5%) 5 (4.6%) 1(1.0%)
3268 617 39.49 2.06 7 (7.3%) 10 (10.2%) 0 (0.0%)
– – 1.04 (0.36; 2.98) 0.43 (0.14; 1.30) –
0.349 0.265 0.473 0.067 –
– – 1.01 (0.35; 2.91) 0.38 (0.13; 1.18) –
0.305 0.261 0.491 0.048 –
206 206 206 206 206
(106/100) (106/100) (106/100) (106/100) (106/100)
74 (69.8%) 16 (15.1%) 8 (7.5%) 8 (7.5%) 20 (18.9%)
58 (58.0%) 25 (25.0%) 13 (13.0%) 12 (12.0%) 21 (21.0%)
1.67 (0.94; 2.97) 0.53 (0.27; 1.07) 0.55 (0.22; 1.38) 0.60 (0.23; 1.53) 0.87 (0.44; 1.73)
0.039 0.039 0.101 0.143 0.351
1.69 (0.95; 3.02) 0.55 (0.27; 1.12) 0.51 (0.20; 1.32) 0.67 (0.25; 1.76) 0.78 (0.38; 1.61)
0.037 0.049 0.084 0.206 0.250
Notes: ‘N’ indicates the sample size. Values are given as number and percentage or mean standard deviation as indicated. * Odds ratios and p-values for Apgar 5 min measure could not be presented as none of the intervention sample met the cutoff. ** One-tailed (right-sided) p value from a t test for continuous outcomes and a test of proportions for binary outcomes. *** One-tailed (right sided) p value from an OLS regression for continuous outcomes and logistic regression for binary outcomes controlling for parity and incidence of previous caesarean section.
compared to the control group; however this result was only a trend in the unadjusted model. Two significant differences were observed for maternal outcomes. In both the unadjusted and adjusted models, the intervention group were more likely to have experienced spontaneous onset of labour compared to the control group. In addition, women in the intervention group were less likely to have a caesarean section than those in the control group. This result was significant in the adjusted and unadjusted models. There were no significant differences regarding emergency and elective caesarean sections; however there was a trend in the adjusted model for emergency caesarean sections. There was no difference for other forms of instrumental delivery. Other variables tested but not presented, including low birth weight, high birth weight and small for gestational age, were also not significant. Comment This study found that prenatal home visits provided to socioeconomic disadvantaged women had no impact on neonatal outcomes or the majority of maternal outcomes, however there was suggestive evidence that it resulted in increased spontaneous onset of labour and a lower caesarean section rate. These findings are in line with well-documented evidence of a relationship between spontaneous labour onset and caesarean section. However, the nature of this relationship is subject to conflicting findings, with observational studies typically identifying a positive relationship between labour induction and caesarean section, [17,18] and experimental studies identifying no effect or a negative relationship [19]. The findings reported here suggest that the intervention may have had an effect on the birthing process. The concurrent increase in spontaneous onset of labour and reduction in caesarean sections suggests that the intervention group displayed less risk indicators that required intervention. A comparison of this sample to maternity outcomes in Ireland [20,21] shows accordance with the national rates regarding gestational age and prematurity. However average birth weight was lower among the study sample which was to be expected given their disadvantaged status [4]. The lack of effects on neonatal outcomes may be attributed to the timing and intensity of programme visits. On average, participants joined the programme during the 22nd week of pregnancy. Thus, efforts to modify mother’s behaviour, such as substance use and eating habits, may
have been delivered too late to significantly impact birth weight and gestational age [22]. These results are consistent with reviews of other home visiting programmes [11,23]. These findings may also be related to insufficient programme intensity. As noted, dosage was lower than intended. This is a significant issue as increased frequency of home visits is associated with improved child outcomes [10]. Given that the home visiting model is based on building relationships of trust between participants and mentors, there should be sufficient time invested in that relationship and adequate exposure to programme materials in order to generate behavioural change. Regarding maternal outcomes, 57% of all deliveries conducted in Ireland in 2010 were spontaneous in onset and 26% of all live births were delivered by caesarean section [20,21]. While these rates are consistent with those experienced by the control group, the intervention group had significantly higher rates of spontaneous onset of labour and lower rates of caesarean section at 70% and 15% respectively. While one must be cautious about attributing these results to the programme, the findings that the intervention group differed from the national average suggests that the programme may have provided benefits above the standard antenatal classes offered in maternity hospitals. The potential impact of the intervention on maternal outcomes may be attributed to the prenatal visits which focused on preparing the mother for the birthing process. The intervention may have served to reduce anxiety around childbirth and increase awareness of labour, however this is a hypothesis which requires further testing. A review of the literature on anxiety and obstetric complications suggests that specific types of anxiety such as psychosocial stress, family functioning and fear of childbirth may increase the likelihood of birth complications [24]. For example, fear of childbirth increases the likelihood of emergency caesarean section, [25] and psychosocial interventions targeting women who request caesarean sections due to fear of childbirth have resulted in less instrumental deliveries [26]. A review found mixed evidence of the impact of anxiety on caesarean sections [27]. The mechanism proposed to explain this relationship is hormone regulation, however support for this hypothesis is mixed [25]. While the sample size precluded us from identifying whether the caesarean effect was concentrated among emergency or elective caesarean sections, the proportion of both procedures was lower in the intervention group. While the choice to have a caesarean section is often made by the obstetrician, maternal preference may play a role in her acceptance of intervention [28].
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Strengths and limitations The study has some limitations. The results are based on one home visiting programme operating in a specific community, and thus may not generalize to other communities or programmes. The sample size employed was relatively small. Yet when data were re-estimated using permutation-based hypothesis [16] testing accommodate to the small sample size, similar results were obtained. Another limitation is that we could not explore the mechanisms underlying the potential effect on maternal outcomes. Although maternal anxiety was measured at baseline, it was not captured at the time of delivery. Thus we cannot observe whether there was a reduction in anxiety during pregnancy which may have affected outcomes. This study has a number of strengths. Robust efforts were made to design a randomisation procedure which preserved the integrity of the experiment. In addition, while the participants were not blind to the treatment condition, hospital staff were blinded. A comparison of the baseline characteristics of the sample found no differences between the intervention and control group suggesting that the sample was balanced. Another significant strength of the study was the efforts to measure contamination. As little evidence of contamination was found, it suggests that the effects may be attributed to the programme [15]. Finally, the majority of studies in this field are restricted to North American data and there is a clear lack of research on the effects of home visiting programmes in European countries with different social and cultural contexts. Conclusion This prenatal home visiting programme had no impact on neonatal outcomes, yet there was suggestive evidence that it prepared women for birth, and potentially reduced the rates of caesarean section and increased the incidence of spontaneous labour. Further studies are required to test these observation generating hypotheses. Obstetric techniques such as caesarean section can be lifesaving, however increases in these procedures has led to concern regarding their overuse particularly in high income countries [29]. Caesarean section, especially those that are not medical justified, include a risk of maternal morbidity and mortality [30], as well as a risk of physical, emotional, and reproductive consequences for the mother and negative health outcomes for the child [31]. The growing rate of caesarean sections also has financial implications as the average cost of elective caesarean section is between 27–63% higher than vaginal delivery [32]. While a greater number of caesarean sections are performed in medium and high income countries, evidence suggests that the correlation between increasing caesarean rates and declining neonatal and maternal mortality is restricted to low income countries [33]. In particular, there is no associated between caesarean section and infant and maternal mortality rates in countries with caesarean section rates of above 15% [34]. That the proportion of caesarean sections in this study’s intervention group was in line with the WHO’s recommendation of an upper limit of 15% [35] is thus significant. While studies of prenatal home visiting programmes have focused on neonatal outcomes, few have examined the potential effects on maternal labour outcomes. The findings presented here suggest that such analysis may prove informative as identifying interventions which improve maternal outcomes in high income countries is significant from both a clinical and financial perspective. Conflict of interest The trial was funded by the Northside Partnership through funding provided by The Atlantic Philanthropies and the
Department of Children and Youth Affairs. The Northside Partnership manages the Preparing for Life programme and funds the evaluation of the programme. Role of funding source The funder had no involvement in the conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The funder had involvement in the original design of the trial.
Contribution to authorship OD designed the study. EMG and EPM contributed to planning the study and data collection. OD and EMG did the primary data analysis. EPM and FMA contributed to supplementary analyses. OD and EMG wrote the report. All authors contributed to the interpretation of the data. All authors approved the final version. OD is guarantor.
Ethics approval The study was approved by the UCD Human Research Ethics Committee, 8 May 2008, ref: HS-07–26-Harmon–Doyle; The Rotunda Hospital Ethic Committee, 12 May 2008; and the National Maternity Hospital Ethics Committee, 28 July 2008. All participants gave informed consent before taking part in the randomisation process. Acknowledgements We thank all those who participated and supported the research, especially the PFL participants, PFL intervention staff, UCD field staff, local community organisations, the Scientific Advisory Team (Professor Colm Harmon, Professor James Heckman, Professor Cecily Kelleher, Professor Sharon Ramey, Professor Sylvana Cote, and Professor Richard Tremblay), and the Expert Advisory Committee (Professor Mark Dynarski and Professor Marjorie Smith) for their support and guidance in this work.
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