Clinical trial NCT01851187: Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes
Official title: A Randomized Control Study of Prenatal Emotion Management on Maternal Emotion and the Delivery Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Problems
Mental Depression
Complications; Cesarean Section
Keywords: Psychological intervention,
prenatal period,
cesarean section rate,
stage of labor
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2013-05-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms assessment
timeFrame: The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum
Secondary outcomes:
measure: Obstetric outcome assessment
timeFrame: after delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: The First People's Hospital of Hangzhou
name: Hejiang Li, MD
role: PRINCIPAL_INVESTIGATOR
References: