Open Myelomeningocele Repair With High Maternal BMI

NCT03044821 | Terminated DMC

• 1 other identifier: H-38734
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neural Tube Defect

Keywords

Neural Tube Defect

Outcome Measures

Primary Outcomes (2)

• Complications associated with obesity during Surgery.

  Determine if there is an increased risk for mothers with a BMI of 35-40 during an open in-utero surgical repair for myelomeningocele.

  At the time of fetal repair surgery.

• Complications associated with obesity during pregnancy.

  Determine if there is an increased risk for mothers with a BMI of 35-40 after having undergone an open in-utero surgical repair for myelomeningocele.

  During the post-surgical course of pregnancy.

Study Arms (1)

Open-Uterus Fetal Repair

EXPERIMENTAL

Single arm study. All patients will receive the open-uterus fetal repair.

Procedure: Open-Uterus Fetal Repair

Interventions

Open-Uterus Fetal Repair PROCEDURE

Single arm study. All patients will receive the open-uterus fetal repair.

Open-Uterus Fetal Repair

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Belfort, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: February 7, 2017
• Study Start: July 18, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

US (1)