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Procedure

Fetal Surgery for Spina Bifida

N/A
Recruiting
Led By Kuojen Tsao, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any woman with a prenatal diagnosis of myelomeningocele
Pre-pregnancy BMI of 35-45 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of fetal repair surgery to 40 weeks gestation
Awards & highlights

Study Summary

This trial is testing offering pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with a BMI of 35-40 kg/m2, diabetes, a history of a previous preterm birth, or a structural abnormality in the fetus.

Who is the study for?
This trial is for pregnant women with a prenatal diagnosis of myelomeningocele who also have a pre-pregnancy BMI of 35-45, controlled diabetes, or a history of both preterm and full-term births. It's not for those with severe diabetes complications, recent heart issues, uncontrolled health problems like high blood pressure or poor glycemic control.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of open fetal repair surgery on myelomeningocele in pregnancies usually excluded from such procedures due to factors like obesity or minor fetal abnormalities. The extended criteria are based on the MOMs trial standards.See study design
What are the potential side effects?
Potential side effects aren't specified but may include risks associated with any surgical procedure during pregnancy such as infection, bleeding, premature birth and potential harm to the fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My unborn baby has been diagnosed with myelomeningocele.
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My BMI before pregnancy was between 35 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of fetal repair surgery to 40 weeks gestation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of fetal repair surgery to 40 weeks gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative complications

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fetal Surgery in Women with exExperimental Treatment1 Intervention
Fetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following: a BMI greater than 35 (but less than or equal to 40 kg/m2) (minor) Fetal structural abnormality (well-controlled) Diabetes Previous preterm delivery (followed by a full term delivery) Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis). Intervention: Open Fetal Repair of Myelomeningocele

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,864 Total Patients Enrolled
1 Trials studying Spina Bifida
50 Patients Enrolled for Spina Bifida
Kuojen Tsao, MDPrincipal InvestigatorThe University of Texas Health Science Center at Houston - UTHealth.
1 Previous Clinical Trials
1,750 Total Patients Enrolled

Media Library

Open Fetal Repair of Myelomeningocele (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02664207 — N/A
Spina Bifida Research Study Groups: Fetal Surgery in Women with ex
Spina Bifida Clinical Trial 2023: Open Fetal Repair of Myelomeningocele Highlights & Side Effects. Trial Name: NCT02664207 — N/A
Open Fetal Repair of Myelomeningocele (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02664207 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the requisite qualifications to be accepted into this clinical trial?

"This study is enrolling forty individuals aged between sixteen and forty-five who have obesity. In addition to this requirement, pregnant women with a prenatal diagnosis of myelomeningocele; pre-pregnancy BMI of 35–45 kg/m2; diabetes but good glycemic control; prior history of preterm birth as long as followed by full term births; minor structural abnormalities in the fetus such as cleft lip or palate, minor ventricular septal defect, pyelectasis; low level anti-red blood cell antibody that is not associated with fetal disease specifically anti-E lower than 1:4 or anti M"

Answered by AI

Is there a call for participants in this experiment at present?

"Correct. According to clinicaltrials.gov, this study initiated on January 26th 2016 and was last updated in May 17th 2022 is currently recruiting 40 patients from 2 medical centres."

Answered by AI

How many subjects are participating in this experiment?

"Affirmative. The clinical trial is still actively enrolling volunteers, as indicated by the information located on clinicaltrials.gov. It was initially listed on January 26th 2016 and has been recently updated on May 17th 2022; 40 participants are needed for this study at 2 sites."

Answered by AI

Does this study encompass individuals beyond the age of thirty-five?

"This research project is looking to include participants aged 16 and up, but no older than 45."

Answered by AI
~13 spots leftby Jan 2028