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Completed

NCT Number: NCT05202639

Decision-making Regarding the Possibility of Medical Termination of Pregnancy

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.

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Key information

Conditions

Medical Termination of Pregnancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. Quantitative auto-questionnaire (Likert scale)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: DEFIMEG

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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