Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05843110 |
| Other study ID # |
APHP 200309 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2021 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Delphine HERON |
| Phone |
01 42 16 13 46 |
| Email |
delphine.heron[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Couples facing with the discovery of fetal isolated CCA during pregnancy find themselves in a
paradigmatic situation of decision-making in a context of extreme uncertainty. They must
decide whether to continue or to terminate the pregnancy based on statistical probabilities
regarding neurodevelopmental prognosis: favourable in about 80% of cases and associated with
an intellectual disability (ID) in about 20% of cases, of variable severity (5% severe). This
complex decision belongs to each couple. In situations of prenatal diagnosis it is currently
known that the predominant factors in decision-making are related to medical information and
to subjective parental perception of the consequences of this information (the potential
suffering of the child, the impact on family life, the quality of life of the child, etc.).
Prognosis' uncertainty complicates this decision-making and brings couples into significant
distress which they express in consultation.
How do couples make their decision? How do they experience this decision over time? These
questions have not yet been the subject of a specific study concerning decision-making in a
context of an uncertain prognosis. It seems essential to better identify the decision-making
mechanisms at stake and to understand the experience of this decision-making over time.
Findings of this study could improve current practices in support of concerned couples.
More broadly, given the global development of technological advances in prenatal diagnosis
(particularly in imaging and genetics), couples are and will increasingly be facing
situations of high prognostic uncertainty. A better understanding of the decision-making
process concerning the outcome of pregnancy seems essential, as well as the psychological
impact of this decision - whatever it may be - on couples. The conclusions of this study,
focused on a paradigmatic situation, could be applied to others. Rooted in an
interdisciplinary approach, it is crucial that the teams question their practice to improve
couples' support during and after pregnancy in all disciplines involved. Finally,
technological progress leads to questions that raise ethical and societal issues. This study
may provide possible methods ways of response. The main objective of this research is to
study the conscious and unconscious factors involved in the couples' decision-making process
regarding the outcome of pregnancy in the context of prenatal diagnosis of isolated CCA.
Moreover, the investigators aim to study the couples' experiences concerning their decision
to continue or terminate the pregnancy and the psychological impact of this decision. The
investigators want to evaluate the impact of time on the experience of their decision. The
investigators expect to identify the needs of the people involved in order to re-evaluate the
practices and improve the care pathway currently proposed.
The study population includes couples who had a fetal announcement of isolated CCA during
pregnancy. Both members are 18 years of age or older benefiting from the social security
system. They will be included in the study from 3 months to 5 years after the end of the
pregnancy (delivery or termination). Signed informed and free consent for each individual is
obtained.
Couples for whom a new pregnancy is in progress, one of whose members does not speak French
and/or is under legal protection and/or is under a security measure and/or suffers from a
decompensated psychiatric pathology known at the time of recruitment cannot be included.
Two groups (50 couples recruited) will be formed in the following way: a first group of 25
couples, who had announcement of fetal isolated CCA during the pregnancy and decided to
continue the pregnancy; a second group of 25 couples, who had an announcement of fetal
isolated CCA during the pregnancy and decided to terminate the pregnancy.
To address the study objectives, this study uses mixed methods:
The experimental adapted emotional self-evaluation scales (R/S scales). The investigators use
retrospective choice self-assessment scales that measure the emotional state associated with
the decision and the desire to modify/reconsider the initial choice ("regret" or "relief"
gradient). The terms of these scales were adapted in collaboration with Sylvain Moutier to
fit the research context, based on our clinical experience.
Anxiety scales (STAI A and B). The STAI inventory is one of the most widely used anxiety
assessment scales. Validated in French, it is composed of 40 items that evaluate trait
anxiety (the subject's usual anxious temperament) and state anxiety (current anxiety at the
time of the interview). The evaluation of these two levels of anxiety and the data already
available for the general population constitute the major interest of this scale.
A depression scale: Beck Depression Inventory (BDI-II). This is an inventory measuring the
depth of depression. This scale is designed to measure the subjective aspects of depression.
It is one of the most widely used scales for the subjective measurement of depression as a
complement to clinical investigation. Because of its brevity, BDI-II is well accepted by
patients and easy to administer.
The post-traumatic stress disorder Checklist version DSM-5 (PCL-5). This scale is used to
assess the state of post-traumatic stress disorder. It measures the three main subsyndromes
of PTSD: re-experiencing, avoidance, hypervigilance. Participants graduate their symptoms
based on the last month prior to taking the scale.
The revised Dyadic Adjustment Scale-16 (DAS-16) inventory. This is an abridged and revised
version of the Dyadic Adjustment Scale (DAS). It studies a couple's reciprocal dyadic
adjustment, which would be evolutionary: thus, it measures each partner's overall perception
of their conjugality and possible marital distress.
Finally, there is a semi-structured research interview. An interview guide was developped
which was submitted to the members participating in the development of this research, during
the meetings of the steering committee (COPIL). This interview allows us to study the
following elements: account and scope of the abnormality's announcement; their experiences of
various specialists' discourses ; content and scope of the information received
(probabilities, multitude of scenarios possible....); how can evolve their representations of
their baby ; the pregnancy's experience ; anticipation or difficulty in anticipating the
consequences of the final decision in relation to uncertainty and doubt; how such a decision
may or may not be made by two people; the opinion of others (family, friends, doctors...).
This interview is based on the long experience of the investigators in supporting concerned
couples. The choice for using a semi-structured research interview was made for several
reasons. First, it allows having varied contents and themes specific to every participant.
Within each theme, it enables studying the thought process and having information on the
effects. It is also a valuable tool in accessing the subjective information of the subject.
When used with couples, it allows studying couple dynamics.
Through these scales and interview, the following hypotheses are tested. Firstly, it is
assume that the psychological impact of decision making following the announcement of fetal
isolated CCA is correlated with decision making (G1: continuation of pregnancy and G2: IMG).
The investigators also believe that in couples who continued the pregnancy (G1), the
psychological impact of decision making is correlated to the subjective parental perception
of their child's degree of impairment.
Finally, the pre-existing representations of disability in general are considered; the
subjective risk of disability related to isolated CCA; pregnancy history; family support;
marital alliance, and medical discourse and attitudes facilitated or hindered the couple's
decision-making.
Couples (who have been followed since 2017) will be informed of the research during a
consultation as part of their routine care (post-MIG consultation, child follow-up
consultation, etc.) by one of the physicians or midwives participating in the study at one of
the 3 participating centers (Neuropediatrics Department, Armand Trousseau Hospital, Fetal
Medicine Department, Armand Trousseau Hospital and Genetics Department, Pitié-Salpêtrière
Hospital).
The physician in charge of this consultation during which he informs couples of the research
and gives them the study information. They are given a one-week period of reflection and a
telephone call will be made by the psychologist-researchers to find out the couple's response
(whether they wish to participate or not in this study).
If the couple agrees to participate in the study, an appointment is scheduled at the
recruiting center (genetics department) with a psychologist-researcher (associate
investigator). During this visit, the investigator (psychologist-researcher) takes time with
the two members of the couple to present the study again (taking over the information note
given by the doctor) and to answer any questions they may have. The research psychologist
checks inclusion and non-inclusion criteria and then collect the free, informed, written
consent of each member of the couple. Then, each member of the couple completes the first
part of the experimental adapted emotional self-evaluation scales (R/S scales), the anxiety
scales (STAI A and B), the depression scale (BDI-II), the post-traumatic stress disorder
scale (PCL-5) and the revised inventory of the dyadic adjustment scale (DAS-16). The
semi-structured research interview is conducted with the two couple members present. Finally,
the second phase of the experimental adapted emotional self-assessment scales (R/S scales) is
completed. It is assumed that the appointment may last nearly 3 hours.
The benefits for the couples who agree to participate in this study could be meeting with the
psychologist-researchers, i.e. to have time to be heard and to elaborate their experience.
The post-pregnancy consultations (in neuropediatrics and genetics) show that couples wish to
talk about pregnancy and their choices. Participation in this study may have positive
psychological effects. For example: meeting professionals who have clinical experience in
accompanying couples in an antenatal diagnosis, a feeling of not being alone, being able to
contribute to the improvement of the care pathway for the future couples involved. There is
no medical benefit to participating in this research.
Any major risk for the couples invited to participate in this study have not been forcast.
However, the research information letter, the scales and the interview may reactivate painful
effects. The investigators anticipate that anyone who has received information about this
research, whether they participate or not will have the opportunity to be referred to a
psychologist if they so desire.
This research promoted by the AP-HP (DRCI) is funded by the Agence de la biomédecine (ABM)
and the Rare Disease Foundation (FMR) and has received a positive opinion from the CPP on
8/12/2020.
