NCT06107530

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

October 5, 2023

Last Update Submit

July 18, 2025

Conditions

Keywords

peri-natal losspregnancy follow up

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

EXPERIMENTAL
Other: semi structured interview

Interventions

Women fulfilling the inclusion / exclusion criteria will be asked to participate to a semi structured interview with a psychiatrist or a psychologist

Semi structured interview

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations