Clinical Trial: Open Myelomeningocele Repair With High Maternal BMI
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Open Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 And 40.0
Brief Summary:
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.
Detailed Summary:
The research will be conducted at the following location(s):
Baylor College of Medicine and Texas Children's Hospital- Women's Pavilion.
About 15 subjects will be enrolled in this study. In order to be eligible for this study, the participant must meet the established criteria for open fetal MMC surgery but also have a BMI of 35.0-40.0.
PREOPERATIVE AND INTRAOPERATIVE CONCOMITANT MEDICATIONS:
The participant will receive two doses of 12 mg betamethasone, 24 hours apart, for fetal lung maturation if the gestational age is greater than 23 weeks. The participant will also receive the prophylactic tocolysis (medications to prevent preterm contractions) indomethacin 50 mg prior to surgery, then 25-50 mg every six to eight hours for 24-48 hours following the surgery, longer if clinically indicated. Magnesium sulfate may also be used intraoperatively - 6 gram IV loading dose followed by a 2 gram/hour continuous infusion for 24 - 72 hours. In addition, if medically indicated, nifedipine (10mg orally) or terbutaline (0.25mg subcuticularly) may be substituted for the indomethacin or magnesium sulfate based on condition and medical judgment. Prophylactic antibiotics will also be administered to the participant prior to the procedure using cefazolin, azithromycin, and/or metronidazole, or if medical history contraindicates the use of cefazolin, clindamycin,azithromycin, and gentamicin will be administered. A solution of nafcillin and lactated ringers will be injected into the amniotic cavity at the conclusion of the procedure. Additional medications, including therapeutic antibiotics, may be used as part of standard of care by the medical team.
MATERNAL-FETAL ANESTHESIA:
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Baylor College of Medicine
Dates:
Date Received: May 24, 2016
Date Started: May 2016
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017
