TerminatedNot Applicable

Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0

United States1 participantsStarted 2015-07

Plain-language summary

Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States. These criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the BMI to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to the comorbidities of the mothers published in the MOMS trial.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Maternal BMI 35.0 to 40.0 * No maternal documented co-morbidities * Fetal MMC begins between thoracic 1 and sacral 1, on the spinal column. * Evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column). * A gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion. * Documented normal fetal karyotype. Exclusion Criteria: * History of maternal alloimmunization problem * Kell sensitization * Risk of preterm birth * History of spontaneous preterm birth * Cervix \<20mm in length * Presence of cerclage * Placental problem * History of placental abruption * Placental Previa * Body-mass index of 40.1 or more * Maternal contraindication to surgery * Insulin-dependent pregestational diabetes * Hypertension or preeclampsia * HIV, hepatitis-B, or hepatitis-C positive * Other medical condition of risk to mother * Uterine problem * Previous hysterotomy in the active uterine segment * Severe fibroids * Uterine malformation (bicornuate, arcuate, unicornuate, didelphys) * No support person for periprocedural period * Inadequate support at home for pregnancy * Inadequate understanding of risks and benefits of fetal surgery * Inability to comply with medical restrictions, follow up after fetal surgery * Multiple gestation pregnancy (twins, triplets, etc.) * A fetal anomaly unrelated to myelomeningocele (heart defect, lung lesions) * Severe fetal kyphosis \>30 degrees (curvature of the back)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Co-morbidities in mothers having fetal MMC repair

Timeframe: up to 40 weeks

Trial details

NCT IDNCT02509377

SponsorSt. Louis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More Myelomeningocele trials