Interaction Between Genetic Factors and Maternal Stressor... | NCT01648816

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

NCT01648816

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 8, 2023Actual

Enrollment

3,338Actual

Phase

Not provided

Conditions

Postpartum Depression

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-A01315-35	Other Grant/Funding Number	ID-RCB

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2011Actual

Primary Completion Date

Sep 4, 2016Actual

Completion Date

Jul 20, 2017Actual

First Submitted Date

Jul 20, 2012

First Submission Date that Met QC Criteria

Jul 20, 2012

First Posted Date

Jul 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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".

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,338Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
postpartum depression		caucasian mothers with postpartum depression
control		caucasian mothers without depression

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depressed subjects at week 8 after delivery (EPDS and DSM I-V criteria for depression)	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian mothers included after pregnancy (J0-J4)

Exclusion Criteria:

Age <18 years old, schizophrenia or mental retardation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

causasian mothers after pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline Dubertret, MD, PhD	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louis Mourier Hospital		Colombes		92700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34496464	Derived	Tebeka S, Le Strat Y, Etain B, Ray M, Mullaert J, Dubertret C; IGEDEPP Study Group. Childhood Trauma and Perinatal Depression: Data From the IGEDEPP Cohort. J Clin Psychiatry. 2021 Sep 7;82(5):20m13664. doi: 10.4088/JCP.20m13664.

ID	Term
D011644	Puerperal Disorders
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases