Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes

Not Applicable

Completed

• Conditions: Perinatal Problems; Mental Depression; Complications; Cesarean Section
• Interventions: Behavioral: antenatal psychological intervention; Behavioral: routine prenatal care

• Registration Number: NCT01851187
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant women. Prenatal and intrapartum negative emotions not only damage the mental health of pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum complications and neonatal outcomes . Due to considerations for the effect on the fetus, there is concern of the use of drug treatment for depression during pregnancy. Therefore, psychological interventions have an important role. According to the WHO global survey in Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had the highest rate of caesarean section without indication (11.7%). The embarrassing "first in the world" of caesarean section rate was causing widespread concern in China. Recently, the Chinese government has launched a project named "promoting the rate of natural childbirth and protecting the health of mother and child", trying to reduce the cesarean section rate especially that without medical indication. Therefore, examining if emotional management is effective in reducing negative emotions of pregnant women as well as decreasing the rate of cesarean section is an important research question. Our study aims to help the pregnant women control their anxiety, depressive feelings and other negative emotions by "emotional self-management group training" and we examine if this can reduce the incidence of depression and improve delivery outcomes.

Detailed Description

This study tried to explore the effectiveness of prenatal emotional management on pregnant women' delivery outcomes. All participants filled the Questionnaire (PHQ-9) at the baseline assessment. Then they were randomly assigned into the emotional management (EM) group and the usual care (UC) group. The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum. Each subject received the EM package In the EM, and the UC was given only routine prenatal care. PHQ-9 and Edinburgh Postnatal Depression scale（EPDS）were used for assessment.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Status Verified: 2013-05
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-10
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. never have a baby before,
2. with single fetus, head position and normal pelvic measurements,
3. were receiving regular antenatal care,
4. were able to schedule and fulfill questionnaires independently.

Exclusion Criteria

1. situation with pregnancy complications,
2. surgical history of diseases,
3. current or previous history of any kind of mental disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
emotional management (EM) group	antenatal psychological intervention	emotional management (EM) group received antenatal psychological intervention
emotional management (EM) group	routine prenatal care	emotional management (EM) group received antenatal psychological intervention
the usual care (UC) group	routine prenatal care	the usual care (UC) group was given routine prenatal care only

Primary Outcome Measures

Name	Time	Method
Depressive symptoms assessment	The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum	All participants were randomly divided into intervention group and control group with 100 in each group. At the baseline assessment, all participants filled the PHQ-9 themselves and instructed by a trained nurse, , the diagnosis of depression was fulfilled by the psychiatrists in our research program. When participants scored over than 10 on the PHQ-9, the diagnostic interview was arranged by a research assistant and was done in one week. At the same time, the results of antenatal physical examination for every participant were collected by our research assistants when a participant was enrolled. After the baseline assessment, participants were randomly assigned into two groups: the emotional management (EM) group and the usual care (UC) group.

Secondary Outcome Measures

Name	Time	Method
Obstetric outcome assessment	after delivery	Obstetric outcome assessment included the rate of cesarean section, especially the rate without medical indications. The duration of total stage and each stage of labor in natural delivery were concerned.

Trial Locations

Locations (1)

The First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China