Antenatal Palliative Care (SPAN)

Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.

In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.

The aim of the study is to describe parents' experience for a better understanding and a better care.

Study Overview

• Status: Completed
• Conditions: Fetal Death; Fetal Anomaly
• Intervention / Treatment: Behavioral: Semi-structured interviews

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon
  • Lyon, France, 69004
    • Service de Gynécologie Obstétrique - Hôpital de la Croix Rousse
  • Pierre-Bénite, France, 69495
    • Service de gynécologie-obstétrique - Centre hospitalier Lyon sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care.

The death of the child may have occurred in utero or after birth.

Description

Inclusion Criteria:

• The woman must be between the ages of 18 and 50 and the adult,
• Participants must have received the information and not have objected to participating in the study,
• the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
• The choice to continue the pregnancy should have been clearly expressed,
• The birth of the child should not be older than 24 months.
• The child's death must be more than 6 months old (or not have occurred)

Exclusion Criteria:

• Non-mastery of the French language,
• Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
• Severe psychiatric or neurological disorders inducing significant cognitive impairment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis	The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.	About 1 hour and 30 minutes

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 11, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Congenital Abnormalities; Fetal Death
• Other Study ID Numbers: 69HCL18_0371

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