Perinatal ProblemsNCT01851187
Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes
A study testing antenatal psychological intervention and routine prenatal care in people with Perinatal Problems and Mental Depression, run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Problems, Mental Depression, Complications; Cesarean Section
- What is being tested?
- antenatal psychological intervention and routine prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- situation with pregnancy complications,
- surgical history of diseases,
- current or previous history of any kind of mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Study of Prenatal Emotion Management on Maternal Emotion and the Delivery Outcomes
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.
Read the 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.
- Being tested
- antenatal psychological intervention, routine prenatal care
- Keywords
- Psychological intervention,, prenatal period,, cesarean section rate,, stage of labor
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antenatal psychological interventionBehavioural
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.
routine prenatal careBehavioural
Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.
| Study group | Role | What they receive |
|---|---|---|
| emotional management (EM) group | Experimental | emotional management (EM) group received antenatal psychological intervention Receives: 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 Receives: Behavioral: routine prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Hejiang Li, MD, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851187
- Sponsor's protocol ID
- Y207858
- Status last verified
- May 2013
- First submitted
- 3 May 2013
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Prenatal Emotion Management on Maternal Emotion and the Delivery Outcomes
- ClinicalTrials.gov ID
- NCT01851187
- Acronym / sponsor ID
- Y207858
- Keywords
- Psychological intervention,, prenatal period,, cesarean section rate,, stage of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emotional management (EM) group | Experimental | Behavioral: antenatal psychological intervention, Behavioral: routine prenatal careemotional management (EM) group received antenatal psychological intervention |
| the usual care (UC) group | Active comparator | Behavioral: routine prenatal carethe usual care (UC) group was given routine prenatal care only |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- situation with pregnancy complications,
- surgical history of diseases,
- current or previous history of any kind of mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antenatal psychological interventionemotion 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. | Behavioural | emotional management (EM) group |
| routine prenatal carePrenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on. | Behavioural | emotional management (EM) group, the usual care (UC) group |
Primary outcome
Depressive symptoms assessment
Time frame: 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.
1 secondary outcome
Obstetric outcome assessment
Time frame: after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hejiang Li, MD principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antenatal psychological intervention and routine prenatal care in people with Perinatal Problems and Mental Depression, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms assessment (time frame: The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.