MyelomeningocelePriumPsyNCT06796972
In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
A study testing Semi-structured interviews with a psychologist in people with Myelomeningocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelomeningocele
- What is being tested?
- Semi-structured interviews with a psychologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately.
- Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old
- Speaking French
- Not presenting a severe psychiatric disorder altering the relationship with reality
- Patient affiliated to a social security system
Who cannot join
- Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
- Patient under State Medical Aid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Foetale Hôpital Armand Trousseau
Paris, Paris, 75012
Lucie GILBAUD, MD, 00 33 6 31 82 32 71, lucie.guilbaud@aphp.fr
About this study
Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future.
Currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.
Read the detailed description
The study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. In order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy.
This study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele.
This is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative.
In practice, the only procedures added by the research will consist of:
- an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- an interview between the father of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- the completion of a decision scale by each of the parents The presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.
- Conditions
- Myelomeningocele
- Being tested
- Semi-structured interviews with a psychologist
- Keywords
- Psychology, fetal myelomeningocele, Parents
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviews with a psychologistOther
Semi-directed interviews using an interview guide on different themes
| Study group | Role | What they receive |
|---|---|---|
| Parents of children operated on in utero | Other | Semi-structured interviews with a psychologist Receives: Other: Semi-structured interviews with a psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying the experience of couples who have chosen fetal surgery
Semi-structured interviews with a psychologist
Measured: up to 18 months
Secondary outcomes (2)
Investigate the decision-making factors that contributed to the choice of prenatal surgery
Semi-structured interviews with a psychologist
Measured: Up to 18 months
Evaluate the quality of the information that couples received regarding the three possibilities proposed when faced with a prenatal diagnosis of myelomeningocele
Semi-structured interviews with a psychologist
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start23 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796972
- Sponsor's protocol ID
- APHP230369
- Acronym
- PriumPsy
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
- ClinicalTrials.gov ID
- NCT06796972
- Acronym / sponsor ID
- PriumPsy / APHP230369
- Conditions
- Myelomeningocele
- Keywords
- Psychology, fetal myelomeningocele, Parents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 28 Jan 2025 (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.
Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future.
Currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.
Detailed description
The study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. In order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy.
This study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele.
This is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative.
In practice, the only procedures added by the research will consist of:
- an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- an interview between the father of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- the completion of a decision scale by each of the parents The presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of children operated on in utero | Other | Other: Semi-structured interviews with a psychologistSemi-structured interviews with a psychologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately.
- Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old
- Speaking French
- Not presenting a severe psychiatric disorder altering the relationship with reality
- Patient affiliated to a social security system
Key exclusion criteria (2 listed)
- Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
- Patient under State Medical Aid
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 |
|---|---|---|
| Semi-structured interviews with a psychologistSemi-directed interviews using an interview guide on different themes | Other | Parents of children operated on in utero |
Primary outcome
Studying the experience of couples who have chosen fetal surgery
Time frame: up to 18 months
Semi-structured interviews with a psychologist
2 secondary outcomes
Investigate the decision-making factors that contributed to the choice of prenatal surgery
Time frame: Up to 18 months
Evaluate the quality of the information that couples received regarding the three possibilities proposed when faced with a prenatal diagnosis of myelomeningocele
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interviews with a psychologist in people with Myelomeningocele, run by Assistance Publique - Hôpitaux de Paris 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 2 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie GILBAUD, MD (00 33 6 31 82 32 71, lucie.guilbaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying the experience of couples who have chosen fetal surgery (time frame: up to 18 months). 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 28 Jan 2025.