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Randomized Clinical Trial of Early Delivery in Fetal Gastroschisis vs. Routine Care

NCT01884324 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-07-13

No results posted yet for this study

Summary

Primary objective: to test the hypothesis that elective early delivery will protect the fetal bowel from the deleterious intrauterine factors late in the pregnancy and will be associated with improved neonatal outcomes.

Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal surgical management of infants with gastroschisis.

Conditions

  • Gastroschisis

Interventions

OTHER

Early Delivery

This will be a randomized clinical investigation. The subjects will be allocated into "early" and "late" delivery groups using concealed allocation envelopes, which will be created prior to the start of the study using a random allocation sequence. The trial will be conducted in an intent-to-treat fashion.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Alireza A Shamshirsaz, M.D. · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884324 on ClinicalTrials.gov