NCT03073382

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

February 1, 2017

Last Update Submit

December 28, 2023

Conditions

Myelomeningocele

Outcome Measures

Primary Outcomes (1)

  • The number of spontaneous preterm delivery

    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.

    1 year

Interventions

Chart reviewOTHER

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent open fetal myelomeningocele repair Ethnicity: Any

You may qualify if:

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

You may not qualify if:

  • excluded if delivery information is unavailable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Heather H Said, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

March 8, 2017

Study Start

January 1, 2017

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share