Medical Termination of PregnancyDEFIMEGNCT05202639
Decision-making Regarding the Possibility of Medical Termination of Pregnancy
An observational study of Medical Termination of Pregnancy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Termination of Pregnancy
- What is being tested?
- Questionnaire
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Official 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
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.
- Conditions
- Medical Termination of Pregnancy
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuation of pregnancy | The parents who have chosen to continue pregnancy will be asked to complete a questionnaire. Receives: Other: Questionnaire | |
| Medical termination of pregnancy | The parents who have chosen to terminate pregnancy will be asked to complete a questionnaire. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Dec 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Termination of PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie VIAUX-SAVELON, MD, Principal investigator, Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202639
- Sponsor's protocol ID
- 69HCL21_0580
- Acronym
- DEFIMEG
- Status last verified
- Aug 2022
- First submitted
- 14 Dec 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05202639
- Acronym / sponsor ID
- DEFIMEG / 69HCL21_0580
- Conditions
- Medical Termination of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuation of pregnancy | – | Other: QuestionnaireThe parents who have chosen to continue pregnancy will be asked to complete a questionnaire. |
| Medical termination of pregnancy | – | Other: QuestionnaireThe parents who have chosen to terminate pregnancy will be asked to complete a questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA 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. | Other | Continuation of pregnancy, Medical termination of pregnancy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie VIAUX-SAVELON, MD principal investigator
Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Termination of Pregnancy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative auto-questionnaire (Likert scale) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.