Study Stopped
Study was stoped according to preliminary analysis.
Randomized Clinical Trial of Early Delivery in Fetal Gastroschisis vs. Routine Care
Early Delivery in Fetal Gastroschisis: a Randomized Controlled Trial of Elective Early Delivery Versus Routine Obstetrical Care
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 13, 2017
July 1, 2017
3.6 years
June 19, 2013
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time on total parenteral nutrition
2 years
Secondary Outcomes (1)
Diagnostic/Antepartum, Postnatal management
3 years
Study Arms (2)
Late delivery
NO INTERVENTIONThis 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.
Early delivery
EXPERIMENTALThe early group will undergo induction of labor at 34 weeks with cesarean delivery reserved for obstetrical indications.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pregnant
- years of age
- Prenatal diagnosis of fetal gastroschisis
- Less than 34 weeks and 0 days gestation
You may not qualify if:
- Greater than 34 weeks gestation
- \. Fetus with massive gastroschisis defect that is not treatable after delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alireza A Shamshirsaz, M.D.
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty Instructor
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 24, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 13, 2017
Record last verified: 2017-07