TerminatedNot Applicable

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

Stopped: Study was stoped according to preliminary analysis.

United States21 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range16 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pregnant
✓. 16-50 years of age
✓. Prenatal diagnosis of fetal gastroschisis
✓. Less than 34 weeks and 0 days gestation

Exclusion criteria

✕. Greater than 34 weeks gestation
✕. 2\. Fetus with massive gastroschisis defect that is not treatable after delivery

What they're measuring

Time on total parenteral nutrition

Timeframe: 2 years

Trial details

NCT IDNCT01884324

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

View on ClinicalTrials.gov More Gastroschisis trials