Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?

Sponsor
Fondation Hôpital Saint-Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT06107530
Collaborator
(none)
42
1
1
8.7
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: semi structured interview
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?
Actual Study Start Date :
Oct 9, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semi structured interview

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

Outcome Measures

Primary Outcome Measures

  1. Identify women's specific needs and expectations for the follow-up of this particular pregnancy [4months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation hôpital Saint Joseph Paris France 75014

Sponsors and Collaborators

  • Fondation Hôpital Saint-Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Hôpital Saint-Joseph
ClinicalTrials.gov Identifier:
NCT06107530
Other Study ID Numbers:
  • GARDEN
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Hôpital Saint-Joseph

Study Results

No Results Posted as of Oct 30, 2023