Antenatal Palliative Care

NCT03795857 | Completed

• 1 other identifier: 69HCL18_0371
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fetal Death; Fetal Anomaly

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Semi-structured interviews BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon

Bron, 69677, France

Location

Service de gynécologie obstétrique - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Service de gynécologie-obstétrique - Centre hospitalier Lyon sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Fetal Death; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: January 14, 2019
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)