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

October 24, 2023 updated by: Fondation Hôpital Saint-Joseph
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Fondation Hôpital Saint Joseph
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne Charlotte LAURENT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify women's specific needs and expectations for the follow-up of this particular pregnancy
Time Frame: 4months
4months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GARDEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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