Antenatal Palliative Care

Fetal Anomaly Clinical Trial

— SPAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795857
• Other study ID #: 69HCL18_0371
• Status: Completed
• Start date: January 14, 2019
• Est. completion date: April 11, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomaly
• Fetal Death

Intervention

Behavioral:
• Semi-structured interviews
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.

Locations

Country	Name	City	State
France	Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon	Bron
France	Service de gynécologie obstétrique - Hôpital de la Croix Rousse	Lyon
France	Service de gynécologie-obstétrique - Centre hospitalier Lyon sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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