Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes

NCT01851187 | Completed DMC

• 1 other identifier: Y207858
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Problems; Mental Depression; Complications; Cesarean Section

Keywords

Psychological intervention,; prenatal period,; cesarean section rate,; stage of labor

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms assessment

  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.

  The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum

Secondary Outcomes (1)

• Obstetric outcome assessment

  after delivery

Study Arms (2)

emotional management (EM) group

EXPERIMENTAL

emotional management (EM) group received antenatal psychological intervention

Behavioral: antenatal psychological intervention; Behavioral: routine prenatal care

the usual care (UC) group

ACTIVE COMPARATOR

the usual care (UC) group was given routine prenatal care only

Behavioral: routine prenatal care

Interventions

antenatal psychological intervention BEHAVIORAL

emotion management included: (1) Establish relationship between the health care workers and the pregnant women, (2) Determine training objectives, (3) Guide to practice relaxation training, including imagination and abdominal breathing. (4) Make cognitive adjustment, (5) Relieve anxiety and tension by scene simulation and stimulus exposure. (6) Learn emotional self-regulation, (7) Improve self-efficacy by group interaction. (8) Teach prenatal knowledge ,(9) Guide interactive trainings between pregnant women and their couples; (10) Visit delivery rooms.

emotional management (EM) group

routine prenatal care BEHAVIORAL

Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.

emotional management (EM) group; the usual care (UC) group

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Zhejiang University: collaborator

Study Sites (1)

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Hejiang Li, MD

  The First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 10, 2013
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

CN (1)