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

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: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: semi structured interview

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Fondation Hôpital Saint Joseph

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	4months

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): March 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): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: peri-natal loss; pregnancy follow up
• 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
• product manufactured in and exported from the U.S.: No