NCT00127946

Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.

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. * Inclusion at 20 GA (gestational age) weeks. * AMNIOECHANGE every 2 weeks from 30 GA weeks Subject: 140 inclusion during 3 years Analysis: Triangular Sequential Evaluation

Conditions

• Gastroschisis

Interventions

Type	Name	Description
PROCEDURE	AMNIOECHANGE	The AMNIOECHANGE consists of a transabdominal infusion of saline (heated to 37 ° C) with a needle 18 or 20 gauge under ultrasound monitoring while avoiding the placenta. In the case of a normal amniotic fluid, it must be replaced volume per volume of saline (eg depending on the tank where the puncture is made, it can be 300 per 300 ml). The total amount of amniotic fluid exchange is 600-900 ml. In cases of oligohydramnios, the AMNIOECHANGE results in a normalized volume of amniotic fluid.

Timeline

• Start date: 2005-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2005-08-09
• Last updated: 2011-08-09

Locations

1 site across 1 country: France