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Fetal Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03073382
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Heather Said, University of Nebraska

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.

Condition or disease Intervention/treatment
Myelomeningocele Other: Chart review

Detailed Description:

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, as the number of previous Cesarean sections increases the risk of intraoperative complications and invasive placentation in subsequent pregnancies. A fetoscopic approach has reemerged in the United States as an alternative to the aforementioned open approach and is currently under further investigation.

Intraoperative fetal distress has been reported and can lead to loss of the pregnancy. Additionally, fetal surgery carries the risks of spontaneous preterm birth and preterm premature rupture of membranes, which subject the fetus to the morbidity of prematurity. This risk of spontaneous preterm delivery is one of the more common and significant drawbacks to the procedure and represents a major hurdle to overcome. In the MOMS trial, 46% of those in the study group compared to 8% in the postnatal repair group experienced spontaneous rupture of membranes. Thirty-eight percent of prenatal repair versus 14% of postnatal repair patients went into spontaneous labor prior to scheduled delivery. The average gestational age at birth was 34 weeks for the prenatal surgery group and 37 weeks for the postnatal surgery group. In another study following the MOMS trial, 100 patient underwent prenatal repair with a reported 32.3% rate of preterm premature rupture of membranes(PPROM) and 37.5% rate of preterm labor. Also reported a modified surgical approach to the hysterotomy and closure among 43 patients and found a 22% rate of PPROM. Thirty-nine percent delivered at 37 weeks or later compared with 21% of the MOMS cohort.

Although the increased risk of preterm delivery is reported, little is known regarding risk factors associated with preterm delivery following this procedure. Soni et al. found that chorioamniotic membrane separation was a risk factor for subsequent PPROM. No studies have been published that assess risk factors for all spontaneous preterm deliveries including both preterm labor and PPROM. The objective of this study is to determine if any maternal, fetal or intraoperative factors can be identified that increase the risk of spontaneous preterm delivery in patients who undergo prenatal open myelomeningocele repair. With the identification of such factors, counseling of the patient and potentially patient selection could be refined in the future.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors Associated With Spontaneous Preterm Delivery Status Post Open Fetal Myelomeningocele Repair
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : May 26, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Chart review
    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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who underwent open fetal myelomeningocele repair Ethnicity: Any
Criteria

Inclusion Criteria:

  • chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele.

Exclusion Criteria:

  • excluded if delivery information is unavailable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073382


Sponsors and Collaborators
Heather Said
Investigators
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Principal Investigator: Heather H Said, MD St. Louis University
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Responsible Party: Heather Said, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT03073382    
Other Study ID Numbers: 26891
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism