Decision-making Regarding the Possibility of Medical Termination of Pregnancy

Medical Termination of Pregnancy Clinical Trial

— DEFIMEG  

Official title:

Decision-making Regarding the Possibility of Medical Termination of Pregnancy on Two Multidisciplinary Prenatal Diagnosis Centers of Maternities Level 3 in Lyon in 2019

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202639
• Other study ID #: 69HCL21_0580
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Medical Termination of Pregnancy

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