Exploring the experiences of parents after fetal surgery for myelomeningocele

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the decision-making processes and psychological impacts on couples who have opted for in utero surgery to repair myelomeningocele in their fetus. It involves semi-structured interviews with both mothers and fathers, conducted by psychology students, to gather qualitative and quantitative data on their experiences before and after the surgery. The aim is to understand the factors influencing their choice and the emotional and psychological effects of the intervention. The study will include couples who have undergone either open surgery or fetoscopy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
* Patient under State Medical Aid

Where it's running

• Service de Médecine Foetale Hôpital Armand Trousseau
  Paris, Paris, France Recruiting

Study contacts

• Study coordinator: Lucie GILBAUD, MD
• Email: lucie.guilbaud@aphp.fr
• Phone: 00 33 6 31 82 32 71

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• tSCS for improving leg strength and walking in kids with spina bifida

  This pilot test will try non-invasive transcutaneous spinal cord stimulation to see if it helps improve leg muscle strength and walking in children with myelomeningocele who can walk a little with help.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07615686

• Transcutaneous spinal stimulation for children and teens with spina bifida

  This study will try gentle, non-invasive electrical stimulation of the spinal cord to see if it can strengthen legs and improve movement in children and teens with spina bifida.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06918119

• Using cryopreserved human umbilical cord to repair spina bifida in fetuses

  This study is testing whether using preserved human umbilical cords can help repair spinal cord defects in fetuses with spina bifida to improve their health and development.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT06042140

• Using stem cells to improve fetal surgery for spina bifida

  This study is testing whether adding stem cells to fetal surgery can help improve walking and movement in babies with a severe form of spina bifida.

  Recruiting Phase 1/2 University of California, Davis · Sacramento, California · NCT04652908

• Comparing two surgical methods for correcting fetal myelomeningocele

  This study is testing two different surgical methods to see which one works better and is safer for fixing a serious birth defect called fetal myelomeningocele before the baby is born.

  Recruiting at 2 sites USFetus · Los Angeles, California and 1 other locations · NCT03856034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.