NCT05202639

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

December 14, 2021

Last Update Submit

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.

Other: Questionnaire

Medical termination of pregnancy

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

Other: 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.

Continuation of pregnancyMedical termination of pregnancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sylvie VIAUX-SAVELON, MD

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

    PRINCIPAL INVESTIGATOR

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

Locations