DEFIMEG: Decision-making Regarding the Possibility of Medical Termination of Pregnancy

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05202639
Collaborator
(none)
25
1
5.1
4.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Other
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jun 5, 2022
Anticipated Study Completion Date :
Jun 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Continuation of pregnancy

The parents who have chosen to continue pregnancy will be asked to complete a questionnaire.

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.

Medical termination of pregnancy

The parents who have chosen to terminate pregnancy will be asked to complete a questionnaire.

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.

Outcome Measures

Primary Outcome Measures

  1. Quantitative auto-questionnaire (Likert scale) [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sylvie VIAUX-SAVELON, MD, Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse - Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05202639
Other Study ID Numbers:
  • 69HCL21_0580
First Posted:
Jan 21, 2022
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 21, 2022