Clinical Trial: Fetal Myelomeningocele

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Risk Factors Associated With Spontaneous Preterm Delivery Status Post Open Fetal Myelomeningocele Repair

Brief Summary: This is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery.

Detailed Summary:

Myelomeningocele encompasses the most common form of spina bifida. The incidence ranges from 2.73-3.80 per 10,000 births in the United States. The extent of neurologic sequela is correlated with the level of the lesion but frequently involves a spectrum of motor dysfunction including paralysis of the lower extremities, contractures in addition to lack of bladder and bowel control. These result in significant lifestyle limitations for survivors. Additionally, hydrocephalus, brainstem herniation and Chiari II malformations are commonly noted. Ventriculoperitoneal shunts are commonly placed in childhood to redirect cerebrospinal fluid and can require revisions later in life.

The Management of Myelomeningocele Study (MOMS) trial revolutionized management of fetuses with myelomeningoceles by demonstrating that prenatal compared to standard postnatal repair resulted in decreased need for cerebrospinal fluid shunts and improved motor function at thirty months. As a result, various centers around the United States began offering prenatal repair to patients less than twenty-six weeks gestation with prespecified maternal and fetal characteristics.

Prenatal repair is not without risk to both the mother and the fetus. The mother must undergo a laparotomy and accept the risks involved with any intraabdominal surgery including bleeding, infection, adhesion formation and damage to nearby organs. Unique to this procedure, a hysterotomy is typically created in the active segment of the uterus to allow for sufficient exposure of the fetal lesion. Like those women who undergo classical Cesarean sections, these patients must undergo Cesarean sections around 37 weeks gestation for all future pregnancies secondary to concern of uterine dehiscence in the setting of labor. This has major implications for the mother's future childbearing potential
Sponsor: Heather Said, MD

Current Primary Outcome: The number of spontaneous preterm delivery [ Time Frame: 1 year ]

Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: February 1, 2017
Date Started: January 1, 2017
Date Completion: June 1, 2017
Last Updated: March 2, 2017
Last Verified: March 2017