A randomized controlled trial: effects of a prenatal depression intervention on perinatal outcomes among Chinese high-risk pregnant women with medically defined complications
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Prenatal psychosocial health has been linked with health behaviors, maternal health, and birth outcomes. This randomized controlled trial evaluated the effects of a prenatal depression intervention on birth outcomes and maternal physical and psychological status at 42 days postpartum. Three hundred fifty-two high-risk pregnant women exposed to obstetric complications with an Edinburgh Postnatal Depression Scale (EPDS) ≥ 9 or a Postpartum Depression Screening Scale (PDSS) ≥ 60 were randomly assigned to the intervention group (n = 176) and control group (n = 176). The intervention group underwent a six-session couple-separated psycho-educational program; the control group received the usual care. All participants were asked to complete questionnaires at late pregnancy (>28 weeks), 3 days postpartum, and 42 days postpartum. The intervention group had a significantly lower cesarean rate and shorter third stage of labor (p < .05). At 42 days after delivery, only 5.1% of participants were lost to follow-up, and the intervention group had significantly less minor and major depression, more sleep time, more satisfaction with their husband and other family members, less concern about taking care of baby, and less breast milk insufficiency than the control group (p < .05). A prenatal psychological intervention model for high-risk pregnant women holds potential as a preventive program that addresses maternal health and birth outcomes.
Trial registration: Chinese Clinical Trial Registry (ChiCTR-IOR-15006433), http://www.chictr.org.cn/enIndex.aspx (retrospectively registered).
KeywordsGroup intervention Postpartum depression Obstetrical complications Birth outcome
This work was supported by the China Medical Board (CMB) (No. 10-020-201206). We gratefully acknowledge the important contributions of our consultants: Cai Yiyun and Chen Jing. We also thank our research staff: Ding Yan and Tao Hua as well as all high-risk pregnant women who participated in the present study. There are no personal, organizational, or financial conflicts of interest.
Compliance with ethical standards
This randomized single-blind controlled trial was conducted from November 1, 2014 to August 31, 2015. It was approved by the ethical committee of the Fudan University affiliated Obstetrics and Gynecology Hospital in 2013 and 2015 (24-C-2015-24, 24) and registered in the Chinese Clinical Trial Registry (ChiCTR-IOR-15006433). After providing their written informed consents, the participants were randomly assigned into the intervention and control groups and asked to complete questionnaires on depressive symptomatology and psychosocial correlates.
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