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Decision-making Process of Couples Confronted With Prenatal Diagnosis of an Isolated CCA

NCT05843110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-06

No results posted yet for this study

Summary

This research promoted by the AP-HP (DRCI) is financed by the Agence de la biomédecine (ABM) and the Fondation Maladie Rare (FMR) and received a favourable opinion from the CPP on 8/12/2020. It aims to describe the decision-making process of couples faced with the discovery of an isolated corpus callosum anomaly in their fetus during pregnancy. Indeed, the anomaly of the corpus callosum in antenatal represents a paradigmatic situation of the clinic of uncertainty for couples and teams, because the prognosis is variable, in 80% of the cases it is favourable and in 20% it is associated with an intellectual deficiency. This study will use a mixed methodology, combining quantitative data (STAI A and B anxiety scale, BDI-II depression scale, PCL-5 post-traumatic stress scale, DAS-16 marital relationship dynamics scale, experimental emotional self-evaluation scales adapted to each member of the couple, R/S scale) and qualitative data (through a research interview of the couple conducted by a research psychologist). In the course of the study, 50 couples will be interviewed between 3 months and 5 years after the pregnancy (post-medical termination of pregnancy and post-delivery), with 25 couples who will have continued the pregnancy and 25 couples who will have terminated the pregnancy. Statistical and qualitative analysis of the data using NVivo software will be performed. The aim is to better understand the factors that lead couples to decide to continue or terminate a pregnancy in a situation of extreme prognostic uncertainty, their experience of their decision and to improve the care pathway currently offered to these couples faced with this type of situation.

Conditions

  • Corpus Callosum Agenesis

Interventions

OTHER

Decision-making process

Retrospective evaluation using scales, questionnaires and a semi-structured interview

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Delphine HERON · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843110 on ClinicalTrials.gov