Status:
UNKNOWN
Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gastroschisis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level o...
Detailed Description
Primary Objective: To compare prospectively the effect of AMNIOECHANGE against classical care on the delay of full enteral feeding in gastroschisis affected foetuses Study: * Multicenter, Randomized...
Eligibility Criteria
Inclusion
- Seen before 30 GA weeks
- Normal karyotype
- Single pregnancy
- Isolated gastroschisis
- No associated disease (maternal)
- Accept randomization and understand the study
Exclusion
- Maternal diabetes
- Maternal infection with HIV, hepatitis
- Preexistent oligohydramnios before inclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00127946
Start Date
November 1 2005
End Date
April 1 2012
Last Update
August 9 2011
Active Locations (1)
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1
Robert Debre hospital, AP-HP
Paris, Paris, France, 75019