Open Myelomeningocele Repair With High Maternal BMI

Stopped early · Not applicable

Conditions studied: Neural Tube Defect

In brief

Spina bifida is a neurological abnormality characterized by an opening in the skin and exposure of the spinal cord on the back of the baby at the time of birth. The complete closure and separation of the spinal cord from the skin occurs in the first month of pregnancy. This form of spina bifida is associated with leg weakness, sensation loss, and bowel and bladder incontinence. The majority of patients (\>80%) also develop increased fluid in the brain, called hydrocephalus, and require additional surgery to treat this problem. Standard treatment of myelomeningocele (MMC) involves closing the opening in the back within the first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges together to prevent infection and injury to the exposed nerves. Of note, this type of surgery does not improve function. The investigators want to study the open in-utero fetal surgery technique in patients who are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of 35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the United States.

Key facts

Study ID

NCT03044821

Run by

Baylor College of Medicine

People needed

1

Starts

2018-07-18

Expected to finish

2019-07-16

Last updated by the study team

2019-08-01

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study.
• Singleton pregnancy
• MMC with the upper boundary located between T1 and S1
• Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation).
• Absence of chromosomal abnormalities and associated anomalies
• Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks
• Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal MCA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.
• Family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
• Family meets psychosocial criteria (sufficient social support, ability to understand requirements of the study).
• Parental/guardian permission (informed consent) for follow up of child after birth.

You may not qualify if…

• Fetal anomaly unrelated to MMC.
• Severe kyphosis.
• Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• A pre-pregnancy body-mass index ≥35
• Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
• Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy.
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
• Maternal medical condition that is a contraindication to surgery or anesthesia.
• Low amniotic fluid volume (Amniotic Fluid Index less than 6cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion.
• Patient does not have a support person (ie. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
• Inability to comply with the travel and follow-up requirements of the trial.
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
• Patient scores as severely depressed on the BDI-II questionnaire; a score of 29 or above.

Where it is running

• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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