Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?
1 other identifier
interventional
9
1 country
1
Brief Summary
Every year in France, around 7,000 children are born without life, following a medical termination of pregnancy (IMG), fetal death in utero (FDIU) or premature delivery ("late miscarriage"). For families affected by perinatal bereavement, the pregnancy that follows this silent birth is a moment apart, between anguish and guilt, joy and apprehension. The aim of this research project is to improve the understanding of what women go through during the pregnancy that follows, with a view to proposing a practical tool for the professionals who take care of them, in order to improve and personalize their follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Shorter than P25 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
October 5, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedJuly 23, 2025
July 1, 2025
4 months
October 5, 2023
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identify women's specific needs and expectations for the follow-up of this particular pregnancy
4months
Study Arms (1)
Semi structured interview
EXPERIMENTALInterventions
Women fulfilling the inclusion / exclusion criteria will be asked to participate to a semi structured interview with a psychiatrist or a psychologist
Eligibility Criteria
You may qualify if:
- Women who have given birth to a stillborn child (singleton or twin pregnancies):
- delivery following fetal death in utero or medical termination of pregnancy at 15 weeks gestational age and later
- extreme preterm birth ("late miscarriage") from 15 weeks gestational age Patient who subsequently carried a pregnancy to term and gave birth to a live, viable child between 2020 and 2023.
- French-speaking patient
- Patient who does not object to her participation in this research study
You may not qualify if:
- Women who have experienced a natural termination of pregnancy ("early miscarriage") before 15 weeks of amenorrhea.
- Women who have given birth by suction in the operating theatre.
- Women who are pregnant with twins in the pregnancy following bereavement. Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation hôpital Saint Joseph
Paris, 75014, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 30, 2023
Study Start
October 9, 2023
Primary Completion
January 30, 2024
Study Completion
March 30, 2024
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share