Effects of prenatal individualized mixed management on breastfeeding and maternal health at three days postpartum: A randomized controlled trial

Early Human Development 141 (2020) 104944

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Effects of prenatal individualized mixed management on breastfeeding and maternal health at three days postpartum: A randomized controlled trial ⁎

Ying Zhaoa, Qiping Linb, Jing Wangb, , Jiangbo Baoa, a b

T

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School of Nursing, Fudan University, Shanghai, PR China Obstetrics and Gynecology Hospital of Fudan University, Shanghai, PR China

A R T I C LE I N FO

A B S T R A C T

Keywords: Breastfeeding Individualized mixed management intervention Maternal health Postpartum depression Prenatal depression

Background: Pregnant women with antenatal depression are more prone to postpartum depression and failure in breastfeeding than women without antenatal depression. The purpose of this study was to evaluate the effectiveness of a prenatal individualized mixed management intervention on breastfeeding and maternal physical and psychological status at three days postpartum. Methods: This randomized single-blind controlled trial was conducted from December 2017 to August 2018 with 182 primiparous women in Shanghai, China. Participants with Edinburgh Postnatal Depression Scale (EPDS) scores ≥9 were randomly allocated to the intervention group (n = 91) or control group (n = 91). The intervention group underwent a 4-session individualized mixed management intervention and the control group received usual care. Feeding patterns, Breastfeeding Self-Efficacy Scale (BSES), Infant Breastfeeding Assessment Scale (IBAS), and EPDS were used to measure the main outcomes. Two-tailed p-values of p < .05 were considered statistically significant. Results: The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group. Conclusion: The prenatal individualized mixed management intervention demonstrated significant short-term improvement in breastfeeding and maternal physical and psychological health at three days postpartum. Trial registration: ChiCTR-IOR-17013761; December 7, 2017.

1. Introduction World Health Organization (WHO) aims to achieve a 50% universal exclusive breastfeeding rate for infants aged 0–6 months by 2025 [1]. To achieve this goal, WHO published recommendations to ensure continuity of support for breastfeeding mothers [2]. Unfortunately, surveyed rates of exclusive and continued breastfeeding were mostly lower and most countries did not achieve the target set by WHO [3]. In the last five years, in rural China only 59.4% initiated breastfeeding early (within 1 h of birth) and 28.7% of infants at six months postpartum were exclusively breastfed [4]. Thus even with extensive public health promotion, breastfeeding rates in China remain low. Depression is a common complication of pregnancy, both prenatally and during the postpartum period. Up to 70% of women report symptoms of depression during pregnancy, and 10–16% meet criteria for major depressive disorder [5]. Furthermore, postpartum depression

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(PPD) is prevalent in China. Additionally, Wang et al. (2017) found a PPD prevalence of 11.8% among 1126 postpartum Chinese participants using the EPDS [6], consistent with previously reported rates of 10–15% [7]. Untreated depressive symptoms across the perinatal period have been associated with adverse effects in both the mother and baby, which may interfere with a mother's decision to initiate and maintain breastfeeding [8]. Multiple studies have demonstrated a relationship between shorter duration of breastfeeding and perinatal depressive symptoms [9,10]. Amiel and colleagues (2017) found that prenatal depressive symptoms at both 18- and 32-weeks gestations were associated with decreased breastfeeding initiation and duration [11]. Further, in a study by Woolhouse et al. (2016), women who reported depressive symptoms at three months gestation had significantly lower rates of breastfeeding at six months postpartum [12]. However, other studies have shown that when antenatal or postnatal depression is taken into account,

Correspondence to: Jing Wang, Obstetrics and Gynecology Hospital of Fudan University, No.128 Shenyang Road, Shanghai 200090, PR China. Correspondence to: Jiangbo Bao, School of Nursing, Fudan University, No.305 Fenglin Road, Shanghai 200032, PR China. E-mail addresses: [email protected] (J. Wang), [email protected] (J. Bao).

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https://doi.org/10.1016/j.earlhumdev.2019.104944 Received 12 March 2019; Received in revised form 18 December 2019; Accepted 19 December 2019 0378-3782/ © 2019 Published by Elsevier B.V.

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Fig. 1. Consort diagram of all participants at recruitment and follow-up.

imperative that health care professionals provide individualized breastfeeding support alongside effective communication skills after delivery [19]. As both psychological intervention and breastfeeding education are indispensable during pregnancy, there is a need for individualized mixed management intervention models for pregnant women at risk of prenatal depression. The long-term effects of prenatal individualized mixed management on breastfeeding and maternal health will be reported elsewhere (Authors, under review). However, there is limited evidence about the short-term effects of such interventions. To fill this gap, this manuscript provides a novel evaluation of the effectiveness of a prenatal individualized mixed management intervention on breastfeeding and maternal physical and psychological status at three days postpartum.

breastfeeding may act as a moderator factor, decreasing or increasing maternal depressive symptoms [13–15]. Since prenatal depression is a major risk factor for PPD [16] and the bidirectional relationship between perinatal depression and breastfeeding, screening and targeted psychological and breastfeeding intervention during pregnancy may help to alleviate depressive symptoms across the perinatal period and promote long-term breastfeeding. A myriad of additional factors contribute to women ceasing breastfeeding prior to six months including nipple pain, low milk supply, latching difficulties [12], insufficient knowledge about breastfeeding, lack of lactation support [17], and low breastfeeding self-efficacy [18]. These problems in early lactation could not only negatively affect women's self-esteem, well-being and their experience of early motherhood, but also lead to clinically significant symptoms of depression [18]. Thus, these concerns need to be taken into consideration when providing health care to mothers. Moreover, research has shown that initial breastfeeding experience may change the outcome of intentional breastfeeding behavior and mothers experiencing breastfeeding difficulties at early postpartum would have pressure and resistance to breastfeeding [19]. Therefore, women need to be prepared for breastfeeding challenges while they are pregnant, and prenatal education related to breastfeeding, depression, and emotional wellbeing should be improved for new mothers [20]. Additionally, it is

2. Methods 2.1. Study design and participants This randomized single-blind controlled trial was conducted from December 2017 to August 2018 in an urban hospital in Shanghai, China. The study was approved by the Ethical Committee at the participating hospital in 2017 (2017–60) and registered in the Chinese 2

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breastfeeding videos and a breastfeeding simulation under the guidance of an International Board-Certified Lactation Consultant. Husbands are encouraged to participate in the psycho-educational sessions so that they are aware of maternal needs and can actively support their wives. In order to ensure intervention fidelity and quality, midwives and lactation consultants are only in charge of delivering content in sessions related to their area of expertise. To prevent missed sessions, intervention appointments were scheduled on the same day as participants' antenatal examinations. Each session focused on a specific topic: (1) session 1 focused on encouraging psychological adjustment during pregnancy to alleviate prenatal depression; (2) session 2 focused on increasing awareness of PPD and supporting participants to prevent and manage PPD with the help of family members; (3) session 3 focused on making psychological and physical adjustments during delivery to reduce childbirth fear and risk of PPD; and (4) session 4 focused on breastfeeding methods and coping skills for breastfeeding problems. All of the psycho-educational sessions were presented using PowerPoint in a quiet clinic room. Between sessions, additional individual consulting related to psychological and breastfeeding problems was delivered through WeChat or telephone according to the individual needs of participants. Especially when the call for support was not answered, or some certain information need be told by pictures or videos, the participants could use Wechat to consult our intervention team.

Clinical Trial Registry (ChiCTR-IOR-17013761). Participants were enrolled if they met the following inclusion criteria: (1) an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 9, (2) in late pregnancy (≥ 28 weeks and < 35 weeks), (3) married primiparous woman pregnant with a single fetus, (4) giving birth in the research hospital, and (5) agreeing to participate. Participants were excluded from this study if they had an intellectual disability or met criteria for major depression disorder by the Mini-International Neuropsychiatric Interview [21]. Informed consent was obtained from all participants included in the study. The sample size was determined based on the assumption that approximately 25% of pregnant Chinese women would report exclusively breastfeeding at three-months postpartum based on prior research conducted by Feng (2015) [22]. In order to detect a 25% increase in exclusively breastfeeding according to the Global breastfeeding scorecard [23], the sample size determination indicated that 158 participants (79 per group) would be needed in order to have 80% power based on a two-sided Chi-square test with p = .05. Assuming a 15% attrition rate, a total of 182 primiparous women (91 per group) were enrolled. 2.2. Procedures Recruitment and screening were conducted at a specialized, tertiary (Grade 3, Class A) maternal hospital antenatal clinic. Those who met the inclusion and exclusion criteria were invited to participate. After providing written informed consent, the participants were randomly assigned to the intervention or control group using a random number table (See Fig. 1 for additional details about recruitment and retention). All participants were asked to complete questionnaires at baseline (≥28 weeks and < 35 weeks) and three days postpartum. All data on maternal physical and psychological status at three days postpartum were collected by trained investigators blind to group assignment.

2.4. Control group The control group received routine obstetric examination and follow-up. Participants completed the data measures at baseline and three days postpartum. If EPDS scores increased during the study period or participants endorsed depressive symptoms during follow-up, such as crying, feeling bad, or having suicidal ideation, they were provided a referral to the perinatal psychology clinic in the research hospital for further psychological consultation and treatment.

2.3. Intervention group The intervention group received an individualized mixed management intervention plus routine care during the prenatal period. This mixed management intervention was developed by two psychiatrists and one International Board-Certified Lactation Consultant based on our previous study, in which we had a unified psychological intervention manual [24]. Before the intervention launched, each session was carried out under the supervision of the research team leader in order to make sure the intervention adhered to the manual and maintain the treatment fidelity. Additionally, the intervention was informed by literature indicating that women need to be prepared for breastfeeding challenges while they are pregnant because the initial breastfeeding experience may affect the outcome of intentional breastfeeding behavior [19]. The individualized mixed management intervention is delivered through a 4-session face-to-face psycho-educational program for firsttime parents focused on perinatal mental health and breastfeeding. Each session lasts approximately 60 min (5 min for discussing perinatal psychological or breastfeeding issues, 45 min for psycho-education to handle with these issues, and 10 min for feedback of each session and counseling about other private issues). The first three sessions aim to: (1) gain insight into the specific factors contributing to the participant's depression and fear during pregnancy, birth, and the postpartum period; (2) design a suitable coping plan; and (3) provide targeted psycho-education based on the particular factors contributing to the participant's depression and fear. The first three sessions are led by three midwives with psychological research backgrounds. The last session is designed to prepare first-time parents for breastfeeding through education about correct feeding concepts, breastfeeding methods, and prevention and resolution of potential breastfeeding challenges. Several teaching tools are utilized, including short

2.5. Measures 2.5.1. Breastfeeding self-efficacy scale (BSES) The BSES is a 33-item questionnaire developed to assess breastfeeding confidence. Each item is answered on a 5-point Likert scale, with sum scores ranging from 33 to 165 [25]. The BSES can be used to assess breastfeeding self-efficacy in both the prenatal and postpartum periods [13]. It has 30 items, with a total score of 30–150. Higher scores indicate higher levels of breastfeeding self-efficacy. The original scale's Cronbach's α is 0.96 [25]. The reliability of the BSES in this sample was 0.98.

2.5.2. Infant breastfeeding assessment scale (IBAS) The IBAS was designed by Yu et al. to assess breastfeeding behavior among Chinese women after delivery [26]. The scale was informed by prior research on breastfeeding assessment tools [27,28], and includes 10 self-report items. The statements in the questionnaire are, “Do your breasts fill up well when you start to feed your baby?”, “What is your nipple type?”, “How well does the infant latch onto the breast?”, “Do you feel the sucking power of your baby when you are breastfeeding?”, “Do you see the baby swallowing and hear the baby swallowing when you feed your baby?”, “Do you feel any pain while feeding your baby?”, “How about your milk production?”, “Are your nipples cracked?”, “What's your baby's reaction after being breastfed?”, and “Are you satisfied with your breastfeeding?”. Items are rated on a 3-point scale to produce a sum score ranging from 0 to 20, with higher scores indicating more effective breastfeeding behavior. The Cronbach's α coefficient was 0.82 and the intra-class correlation coefficient of was 0.90 [26]. The reliability of the IBAS in this sample was 0.71. 3

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2.5.3. Edinburgh postnatal depression scale (EPDS) The EPDS is a 10-item self-report scale, with scores ranging from 0 to 3, which measures the presence and intensity of depressive symptom within the past seven days. The EPDS has been validated for both antepartum and postpartum use worldwide [29]. The Chinese version of the EPDS shows fair to good psychometric properties for the detection of minor and major perinatal depression and has good internal consistency [30]. In this study, higher scores indicated higher levels of depressive symptomatology.

Table 1 Demographic characteristics and psychosocial events of participants at baseline.

2.5.4. MINI-international neuropsychiatric interview (MINI) The MINI is a short structured diagnostic interview developed jointly by psychiatrists and clinicians in the United States and Europe for DSM-IV and ICD-10 psychiatric disorders [21]. Si et al. reported that the Chinese version of the MINI has a mean sensitivity was 91.2% -100% and a kappa value of 0.94 [31]. In this study, pregnant women with an EPDS score ≥ 9 were interviewed by one trained midwife using the Chinese version of the MINI to exclude participants with major depressive disorder. 2.5.5. Maternal status at three days postpartum This questionnaire assessed maternal sleep time (in hours), maternal appetite, degree of wound pain (using the numerical rating scale ranging from 1 to 10, where 1 indicates not painful at all and 10 indicates very painful), blood loss, infant feeding method, and breastfeeding initial experience. Infant feeding method data were recorded in accordance with definitions from the WHO [32]. Exclusive breastfeeding is defined as only maternal milk and nothing else. Complementary breastfeeding is defined as a combination of breast milk and formula, which can be divided into three types according to the percent of breast milk: (1) most breast milk (≥ 80%); (2) part breast milk (20–79%); and (3) less breast milk (< 20%). Formula feeding is defined as offering exclusively bottle-fed formula.

Variables

Intervention group(n = 91)

Control group(n = 89)

Value

P value

Age (years) (Mean ± SD) Education Middle school or lower Vocational college College degree Master or above Working status Full-time employed Unemployed Monthly household income (RMB) < 6000 6000–7999 8000–9999 ≥10,000

30.70 ± 3.43

29.98 ± 3.23

1.459a

0.146

4.336b

0.227

6(6.6%)

11(12.4%)

21(23.1%) 44(48.3%) 20(22.0%)

19(21.3%) 48(53.9%) 11(12.4%) 1.517b

0.218

67(73.6%) 24(26.4%)

58(65.2%) 31(34.8%) 2.606d

0.451

0.473a

0.637

0.835b

0.361

1.778b

0.182

0.004b

0.947

0.000c

1.000

1.695d

0.454

2.308b

0.315

0.000c

0.985

2.287c

0.130

0.270b

0.603

2.587d

0.288

-1.709a

0.089

Gestational weeks when enrolled Pregnancy complication Yes No Unintended pregnancy Yes No Worry about fetus Yes No Care about fetal gender Yes No Relationship with family members Very good Good General Work pressure High General Low Depression history Yes No Family history of depression Yes No Stress event during pregnancy Yes No Nipple conditions Normal Crater Flat EPDS scores when enrolled

2.6. Statistical analyses Data were analyzed using SPSS version 19.0. Continuous variables are expressed as mean ± standard deviation, and categorical variables are reported as percentages. Chi-square tests, Fisher's exact tests, and independent sample t-tests were used to test for differences on the demographic variables, maternal physical status, EPDS scores, breastfeeding patterns, self-efficacy, and breastfeeding behavior at three days postpartum between the intervention and control groups. As noted in Fig. 1, a relatively small number of control group mothers were lost during follow-up and thus these cases were excluded from the final analyses. Relationships between all the breastfeeding variables and EPDS scores were analyzed using Spearman's and Pearson correlations. Two-tailed p-values of p < .05 were considered statistically significant. 3. Results 3.1. Sample characteristics Of the initial sample of 182 women, 180 (98.9%) completed followup measures at three days postpartum and were included in analyses. The attrition rate was 1.1%. Table 1 presents the demographic characteristics of the study sample. The participants in the intervention and control groups did not differ significantly in age, education, working status, monthly household income (RMB), gestational weeks when enrolled, complications during pregnancy, intendedness of pregnancy, worry about fetal health, care about fetal gender, relationship with family members, work pressure, depression history, family history of depression, stress events during pregnancy, nipple condition, or EPDS scores when enrolled. This suggests that random assignment generated equivalent groups at baseline. A total of 120 participants (65.9%) delivered vaginally, 61 (67.0%)

a b c d

3(3.3%) 14(15.4%) 16(17.6%) 58(63.7%) 45(25.6%) 29.92 ± 1.78

24(26.4%) 67(73.6%)

7(7.9%) 17(19.1%) 12(13.5%) 53(59.5%) 45(25.6%) 29.80 ± 1.78

29(32.6%) 60(67.4%)

36(39.6%) 55(60.4%)

44(49.4%) 45(50.6%)

76(83.5%) 33(26.6%) 15(16.5%) 3(2.4%)

74(83.1%) 33(26.6%) 15(16.9%)

4(4.4%) 87(95.6%)

4(4.5%) 85(95.5%)

49(53.8%) 39(42.9%) 3(3.3%)

40(44.9%) 44(49.5%) 5(5.6%)

25(27.5%) 45(49.4%) 21(23.1%)

16(18.0%) 50(56.2%) 23(25.8%)

1(1.1%) 90(98.9%)

2(2.2%) 87(97.8%)

6(6.6%) 85(93.4%)

1(1.1%) 88(98.9%)

33(36.3%) 58(63.7%)

29(32.6%) 60(67.4%)

86(94.5%) 4(4.4%) 1(1.1%) 10.74 ± 1.81

88(98.9%) 1(1.1%) 0(0.0%) 11.21 ± 1.94

Obtained by t-test. Obtained by χ2. Obtained by continuity correction χ2. Obtained by Fisher's exact test.

in the intervention group and 59 (66.3%) in the control group. There were no significant differences in cesarean rate between the two groups (χ2(1) = 0.011, p = .916). Similarly, no significant differences were 4

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Table 2 Maternal and infant status between the two groups at three days postpartum. Intervention (n = 91) Sleep time (hours) Appetite Good General Bad Postpartum bleeding Less General More Degree of wound pain EPDS scores Infant status Normal Stay in NICU

Control (n = 89)

6.10 ± 1.78

5.38 ± 2.16

51(56.0%) 37(40.7%) 3(3.3%)

35(39.3%) 45(50.6%) 9(10.1%)

29(31.9%) 61(67.0%) 1(1.1%) 4.57 ± 1.98

17(19.1%) 71(79.8%) 1(1.1%) 5.13 ± 2.04

5.98 ± 3.50

7.55 ± 4.36

87(95.6%) 4(4.4%)

79(88.8%) 10(11.2%)

Value

Table 3 Breastfeeding status between the two groups at three days postpartum.

P value

2.425 a 6.631b

0.016⁎ 0.034⁎

4.082b

0.082

-1.881a

0.062

-2.664a 2.935b

0.008⁎⁎ 0.087

Intervention Feeding method (n = 180)c Pure breast milk Most breast milk Part breast milk Less breast milk Formula milk Breastfeeding initial experience (n = 180)c Unsuccessful General Successful Breastfeeding behavior (n = 166)d Breastfeeding selfefficacy (n = 166)d

Control

Value 12.438

20(22.0%) 25(27.5%) 24(26.3%) 10(11.0%) 12(13.2%)

P value a

0.014⁎

17(19.1%) 10(11.3%) 22(24.7%) 22(24.7%) 18(20.2%) 18.391a

0.000⁎⁎

5(5.5%) 46(50.5%) 40(44.0%) 12.46 ± 3.50

24(27.0%) 44(49.4%) 21(23.6%) 11.29 ± 3.53

2.139b

0.034⁎

108.26 ± 22.50

98.24 ± 30.47

2.391b

0.018⁎

a

Obtained by t-test. Obtained by Fisher's exact test. ⁎ p < .05. ⁎⁎ p < .01.

Obtained by χ2. Obtained by t-test. c Breastfeeding patterns and breastfeeding initial experience were reported for 91 participants in the intervention group and 89 participants in the control group. d 87 participants in the intervention group and 79 participants in the control group completed the BSES and IBAS. ⁎ p < .05 ⁎⁎ p < .001. a

b

b

noted in gestational age between the two groups (t(178) = −0.337, p = .736). 3.2. Maternal and infant status Table 2 presents the maternal and infant status results between the two groups at three days postpartum. Participants in the intervention group had significantly more sleep time and better appetite than those in the control group (p < .05). No differences in degree of wound pain, bleeding, or infant status were observed in the intervention group compared to controls. The mean EPDS score of the intervention group was 5.98 (SD = 3.50; range = 0–16), while that of the control group was 7.55 (SD = 4.36; range = 0–18). An independent samples t-test revealed a statistically significant difference between the two groups (p < .01). Participants in the intervention group had significantly lower EPDS scores at three days postpartum.

Table 4 Correlations between breastfeeding and EPDS scores at three days postpartum. EPDS scores

Feeding method (n = 180) Breastfeeding initial experience (n = 180) Breastfeeding behavior (n = 166) Breastfeeding self-efficacy (n = 166)

r

P value

0.193a −0.375a −0.265b −0.521b

0.009⁎ 0.000⁎⁎ 0.001⁎ 0.000⁎⁎

a

Obtained by Spearman correlation. Obtained by Pearson correlation. ⁎ p < .01. ⁎⁎ p < .001. b

3.3. Breastfeeding status Table 3 presents the breastfeeding status results between the two groups at three days postpartum. There were 14 newborns in the NICU at three days postpartum for further observation and treatment because of severe jaundice and hypoxia after birth. Therefore, although 180 participants had data for breastfeeding patterns and initial experience, only 166 completed the BSES and IBAS. The mean BSES and IBAS scores for the intervention group were 108.26 (SD = 22.50; range = 50–150) and 12.46 (SD = 3.50; range = 3–19), respectively, while those of the control group were 98.24 (SD = 30.47; range = 30–150) and 11.29 (SD = 3.53; range = 0–19), respectively. There were statistically significant differences between the two groups in the independent samples t-test and Chi-square test (p < .05). Participants in the intervention group had higher breastfeeding self-efficacy scores (p < .05), more effective breastfeeding behavior (p < .05), and more successful breastfeeding initial experience (p < .05).

experience (r(180) = −0.375, p < .001), breastfeeding behavior, (r (166) = −0.265, p = .001), and breastfeeding self-efficacy (r (166) = −0.521, p < .001).

4. Discussion This study revealed that the individualized mixed management intervention was effective at promoting breastfeeding and improving maternal health at three days postpartum. As previously mentioned, perinatal depression may contribute to adverse infant-feeding outcomes, including breastfeeding difficulties and reduced breastfeeding duration, while not engaging in breastfeeding may increase the risk of PPD in mothers [10,11]. Based on the bidirectional relationship between perinatal depression and breastfeeding, we developed an individualized mixed management intervention to combine the psychoeducation and breastfeeding education targeting primiparous women at risk for perinatal depression. Our results indicated that the early identification and treatment of maternal depressive symptoms may have the added benefit of improving early breastfeeding rates. Likewise, appropriate and compassionate support for women experiencing early breastfeeding difficulties may have the added benefit of reducing maternal depression [12].

3.4. Correlations between breastfeeding and EPDS scores Table 4 presents the correlations between breastfeeding and EPDS scores at three days postpartum. There were significant correlations between breastfeeding and EPDS scores at three days postpartum. EPDS scores positively correlated with feeding pattern (r(180) = 0.193, p = .009), but negatively correlated with breastfeeding initial 5

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early postpartum period should prompt the clinician to screen women for breastfeeding challenges. These findings suggest that targeted measures that reduce depressive symptoms during the perinatal period may help to improve breastfeeding self-efficacy and behavior, and may even promote exclusive breastfeeding. Thus, those with higher depression scores during pregnancy are the target population for further mental health follow-up and tailored care to prevent postnatal depression, early cessation of breastfeeding, and other breastfeeding issues. This study had a few limitations. First, we only recruited participants from one women's hospital, which limits the generalizability of findings. Second, the present study's sample included only primiparous women with a single fetus and an EPDS score ≥ 9; therefore, replication is warranted with a larger, more diverse population. Third, data collection was mainly based on participants' self-report, which may lead to overestimation or underestimation of the prevalence of perinatal depressive symptoms. Finally, measuring outcomes at three days postpartum may be an insufficient time to determine the effects of the intervention on exclusive and sustained breastfeeding and may be too short a time to assess postpartum depression. However, in this study we show only the short-term effects of the prenatal individualized mixed management intervention on these early outcomes. The long-term effects of the intervention will be described elsewhere.

Consistent with previous literature, high breastfeeding self-efficacy has been shown to be predictive of positive breastfeeding outcomes [33]. The individualized mixed management intervention enhanced maternal breastfeeding self-efficacy and improved breastfeeding behavior in the intervention group, which may lead to more successful early breastfeeding experience and better breastfeeding patterns. Moreover, lack of partner support is associated with early interruption of exclusive breastfeeding [34]. In our study, the individualized mixed management intervention got husbands involved by encouraging them to support their wives in initiating breastfeeding as early as possible after delivery and sticking to breastfeeding as long as possible. The higher level of social and family support experienced by the intervention group contributed to the higher levels of maternal self-efficacy and improvements in breastfeeding rates, which was in agreement with previous studies [35,36]. In this study, the EPDS scores decreased from baseline to three days postpartum in both groups, but the decrease in EPDS was more substantial in the intervention group. Furthermore, participants in the intervention group had significantly more sleep time and better appetite than those in the control group. This could also be explained by the enhanced knowledge and coping skills related to postpartum depression which the intervention group received from the psycho-education sessions during the prenatal period. These results are compatible with our previous study [24], which indicated that psychosocial interventions during pregnancy and extended support through the postpartum period were effective at reducing and preventing postpartum depression. Thus, interventions that target postpartum physical and psychological care for groups at risk of PPD during pregnancy could improve maternal health at three days postpartum. Different from our previous group intervention study [24], the combination of the psycho-education and breastfeeding instruction was used to promote an individualized approach to successful breastfeeding and physical and emotional well-being of primiparous women. In our study, none of intervention sessions were missed. These new mothers needed individual support by health care professionals and time to talk about their feelings regarding the difficulty of exclusive breastfeeding and psychological issues to successfully manage both breastfeeding and mental health problems. Moreover, various modalities need to be utilized when providing support to enhance psychosocial well-being [37]. Although resource intensive, the flexible and private nature of this individualized mixed management intervention undoubtedly contributed to the 100% compliance observed in this study, compared to the 39.2% compliance rate observed in our previous study of group psycho-education intervention sessions [24]. Moreover, in this study, the primiparous women were supported by WeChat or phone when needed between sessions until three days postpartum. Thus, in line with de Jager et al. [33], the positive outcomes of this intervention could also be due to continuous personalized intervention patterns, which gave full consideration to each individual's own challenges and strengths. However, this individualized intervention appears to be less cost-effective, which may greatly increase the burden of medical staff. But weighing the pros and cons, this individualized mixed management intervention should be recommended for sustainable use among the first-time mothers at risk of perinatal depression. Prospective evidence indicates that depressive symptoms may predate breastfeeding cessation, and women's confidence in their ability to breastfeed effectively is independently associated with better emotional health postpartum [18]. The results of this study also demonstrated that mothers with higher EPDS scores (suggestive of a postpartum depression episode) in the early postpartum period had lower rates of exclusive breastfeeding, less successful breastfeeding experience, lower levels of breastfeeding self-efficacy, and worse breastfeeding behavior. Our results align with the findings reported in previous studies, which indicate that mothers who suffer from significant depressive symptoms may also experience less confidence in their ability to breastfeed [8,12]. These findings are particularly relevant as higher EPDS scores in the

5. Conclusions There is a high prevalence of depressive symptoms among new mothers, and most mothers with PPD do not continue breastfeeding for the recommended duration [38]. As a prior study by Dennis et al. [39] reported that factors predictive of a lower likelihood of breastfeeding exclusivity included not exclusively breastfeeding at 1 week postpartum and Edinburgh Postnatal Depression Scale score of 10, which indicated that maternal breastfeeding and mood states during the first few days postpartum should be considered, and providing sustainable lactation guidance and psychological support could be beneficial for stimulating successful breastfeeding in more vulnerable women. Accordingly, improved depression screening and treatment during perinatal visits and promotion of lactational support services may better address the high rates of perinatal depression and suboptimal breastfeeding behaviors. This is the first randomized clinical trial that examines the effectiveness of a prenatal individualized mixed management intervention in a Chinese maternity hospital. This study demonstrated the effectiveness of this intervention on improving breastfeeding self-efficacy and behavior, promoting successful breastfeeding initial experience, increasing social support, and reducing postnatal depression among primiparous women. Thus, this individualized mixed management intervention is suitable for clinical use and can be routinely implemented by health care providers in the prenatal period to eliminate barriers to breastfeeding, promote breastfeeding, and improve perinatal depression management efficiency.

Acknowledgements This study was funded by Fudan University Nursing Research Funding, protocol No. FNF201605. We appreciate the support for data collection from the nurses in the prenatal clinic and postnatal wards at the participating hospital. We sincerely thank all participating primiparous women for their cooperation and all researchers in the intervention program for their hard work.

Declaration of competing interest None declared. 6

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