Prevalence of Psychological Disorders After Immediate Postpartum Hemorrhage
PSYCHE
2 other identifiers
interventional
1,968
1 country
1
Brief Summary
The objective of this cross-sectional study is to assess the prevalence of depression at 2 months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential serious consequences of PPH may lead to a greater number of psychological disorders in these women than in women without PPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedStudy Start
First participant enrolled
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedDecember 31, 2018
December 1, 2018
2.3 years
April 7, 2017
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prevalence of depression
the prevalence of depression, measured by the Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11
at 12 months after delivery.
Secondary Outcomes (10)
prevalence of depression among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)
at 2 months, 6 months, and 12 months after delivery.
The prevalence of depression among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention
at 2 months, 6 months, and 12 months after delivery
severity of depression among women with PPH between 500-1000 mL compared with those with severe PPH (≥ 1000 mL)
at 2 months, 6 months, and 12 months after delivery
severity of depression among women with a PPH requiring a so-called second-order medical intervention (transfusion, vascular embolization, etc.) compared with women who had a PPH without such a second-order intervention
at 2 months, 6 months, and 12 months after delivery
prevalence of anxiety and post-traumatic stress among women after an immediate PPH
at 2 months, 6 months, and 12 months after delivery
- +5 more secondary outcomes
Study Arms (3)
women in the nonexposed group without a hemorrhage
EXPERIMENTALwomen in the exposed group with a hemorrhage
EXPERIMENTALPartners
EXPERIMENTALInterventions
The Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11.
The GAD-7 with a discrimination threshold ≥10.
Spielberger's State-Trait anxiety inventory, Form Y (validated in French), with a STAI (form Y-A) discrimination threshold ≥ 46
The IES-R, validated in French, with a discrimination threshold ≥ 30.
Eligibility Criteria
You may qualify if:
- women who gave birth at a term ≥ 22 weeks' gestation or, if the term is unknown, to a fetus with a birth weight ≥ 500 g),
- regardless of the type of delivery (vaginal or cesarean),
- regardless of parity or fetal presentation,
- and regardless of type of pregnancy (singleton or multiple).
- and affiliated with French CNAMTS (salaried worker) health insurance.
You may not qualify if:
- Women who are:
- minors,
- who do not understand French,
- who refuse to participate (did not sign consent),
- and who did not give birth at the Clermont-Ferrand University Hospital Center maternity unit and were secondarily transferred there postpartum.
- For the partners:
- Partner of a woman who gave birth at a term ≥ 22 weeks of gestation or, if the term is unknown, to a fetus with a birth weight ≥ 500 g),
- Regardless of the type of delivery (vaginal or cesarean),
- Regardless of parity and fetal presentation,
- And regardless of type of pregnancy (singleton or multiple),
- And both partners are affiliated with French CNAMTS (salaried worker) health insurance.
- Partner of a woman who gave birth at a term \< 22 weeks of gestation or, if the term is unknown, to a fetus with a birth weight \< 500 g),
- Partner who does not understand French,
- Who refuses to participate (does not sign consent),
- Partner who is a minor,
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
Pranal M, Legrand A, de Chazeron I, Llorca PM, Vendittelli F. Prevalence of maternal psychological disorders after immediate postpartum haemorrhage: a repeated cross-sectional study - the PSYCHE* study protoco. BMJ Open. 2019 Sep 4;9(9):e027390. doi: 10.1136/bmjopen-2018-027390.
PMID: 31488469DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marine PRANAL JULIEN
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- open
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 19, 2017
Study Start
April 27, 2017
Primary Completion
August 1, 2019
Study Completion
February 1, 2020
Last Updated
December 31, 2018
Record last verified: 2018-12