Overview

This trial is active, not recruiting.

Condition gastroschisis
Treatment amnioechange
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2005
End date April 2012
Trial size 140 participants
Trial identifier NCT00127946, P040416

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.
amnioechange 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.
(No Intervention)
This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.
amnioechange 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.

Primary Outcomes

Measure
Duration of ventilation in the ICU and the duration of parenteral nutrition
time frame: 7 days and 45 days after the birth of the child

Secondary Outcomes

Measure
Evaluation of the contribution of iterative AMNIOECHANGE
time frame: 7 days, 45 days, 12 months and 18 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Seen before 30 GA weeks - Normal karyotype - Single pregnancy - Isolated gastroschisis - No associated disease (maternal) - Accept randomization and understand the study Exclusion Criteria: - Maternal diabetes - Maternal infection with HIV, hepatitis - Preexistent oligohydramnios before inclusion

Additional Information

Official title Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.