Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression (IGEDEPP)

September 7, 2023 updated by: Assistance Publique - Hôpitaux de Paris

"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.

Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".

Study Overview

Status

Completed

Detailed Description

"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.

Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction).

We want first to analyze the allelic association between SNPs of 5-HT, HPA and neurodevelopment genes and PPD with a case control association study We then analyse the interaction between maternal stressors during pregnancy and SNPS of our candidate genes (CRHR1, 5-HTT, TPH, BDNF, HMCN1).

3000 Caucasian mothers are included after pregnancy in 8 maternities and are evaluated at the inclusion, at 8 weeks and at 1 year with DIGS, FISC, EPDS and HAD, Stressful life events (Paykel). Blood are collected for all subjects for DNA extraction.

At week 8 and 1 year after pregnancy we search PPD with EDPS and DSM-IV criteria of depression".

Study Type

Observational

Enrollment (Actual)

3338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Colombes, France, 92700
        • Louis Mourier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

causasian mothers after pregnancy

Description

Inclusion Criteria:

  • Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

  • Age <18 years old, schizophrenia or mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
postpartum depression
caucasian mothers with postpartum depression
control
caucasian mothers without depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)
Time Frame: 8 weeks after delivery
Postnatal depression detected by a possible depression (EPDS score > 8) and then confirmed (if EPDS score > 8) by DIGS DSM-IV depression criteria.
8 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Caroline Dubertret, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2011

Primary Completion (Actual)

September 4, 2016

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimated)

July 24, 2012

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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