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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107530
• Other study ID #: GARDEN
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Fondation Hôpital Saint-Joseph
• Contact: Anne Charlotte LAURENT, MD
• Phone: +144127963
• Email: aclaurent[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
France	Fondation hôpital Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify women's specific needs and expectations for the follow-up of this particular pregnancy		4months