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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05202639
Other study ID # 69HCL21_0580
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date February 22, 2022

Study information

Verified date August 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to improve professional practices by better understanding parents who face the choice of medical termination of pregnancy. The hypothesis of the study is that the decision to continue the pregnancy with a serious fetal pathology is more based on the belief and the representations of parents than on the diagnosis or prognosis criteria of the fetus. A better understanding of the parents' motivations on their decision making by knowing what they expect from the caregivers would allow the division of representations, a better prenatal advice and a better perinatal support.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date February 22, 2022
Est. primary completion date February 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults without age limit - Couples or single mothers seen at hospital in 2019 - Couples or single mothers who have been taken care at the Antenatal Diagnosis Center - Couples or single mothers whose file has been presented to a Multidisciplinary Prenatal Diagnosis Center (MPDC) - MPDC's legal authorization of medical termination of pregnancy for severe fetal pathology (fetal reason) Exclusion Criteria: - MPDC's legal authorization of medical termination of pregnancy for maternal reason - Parents who have requested an opinion on another MPDC (with continuation of care in another center) - Fetal death in utero before couple's decision to continue or terminate the pregnancy - Psychiatric pathology preceding the pregnancy - Non-affiliation to health insurance plan - No possible communication (language barrier) - Participation refusal - Adult patient protected under the terms of the law (Public Health Code)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
A questionnaire will be sent by e-mail to the mother and to the father separately. A return of the completed questionnaire is expected within 6 weeks via a secure internal platform pertained to the HCL ("Hospices Civils de Lyon"). The aim of this questionnaire is to identify the factors associated with the continuation or not of pregnancy after diagnosis of severe fetal pathology and after legal authorization of medical termination of pregnancy given by the Multidisciplinary Center of Prenatal Diagnosis.

Locations

Country Name City State
France Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse Lyon

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 Quantitative auto-questionnaire (Likert scale) Quantitative comparison of motivations related to the condition of the fetus versus motivations related to the beliefs and representations of the parents evaluated with a quantitative auto-questionnaire (Likert scale) completed more than one year after the diagnosis of severe fetal pathology.
Each item of the questionnaire completed by parents who continued or terminated the pregnancy will be scored with a Likert scale. The sums of the Likert scores for the items concerning the fetus and the parental beliefs and representations will be compared.
1 year
See also
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Recruiting NCT04294212 - Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital