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

Completed

• Conditions: Postpartum Depression

• Registration Number: NCT01648816
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

"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)".

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 Timeline

• Study Start: 2011-11-02
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-24
• Primary Completion: 2016-09-04
• Study Completion: 2017-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3338

Inclusion Criteria

• Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria

• Age <18 years old, schizophrenia or mental retardation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)	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.

Trial Locations

Locations (1)

Louis Mourier Hospital; 🇫🇷 Colombes, France