Decision-making Regarding the Possibility of Medical Termination of Pregnancy
DEFIMEG
1 other identifier
observational
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedSeptember 7, 2022
August 1, 2022
2 months
December 14, 2021
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Continuation of pregnancy
The parents who have chosen to continue pregnancy will be asked to complete a questionnaire.
Medical termination of pregnancy
The parents who have chosen to terminate pregnancy will be asked to complete a questionnaire.
Interventions
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.
Eligibility Criteria
The study population will be couples whose files were presented to the Multidisciplinary Prenatal Diagnosis Centers of two level 3 maternity hospitals in Lyon during 2019 for a severe fetal pathology, and for which the authorization of medical termination of pregnancy was delivered.
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse
Lyon, 69004, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie VIAUX-SAVELON, MD
Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2021
First Posted
January 21, 2022
Study Start
December 15, 2021
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
September 7, 2022
Record last verified: 2022-08