Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Conditions
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Gastroschisis

Intervention / Treatment
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* Procedure: AMNIOECHANGE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMNIOECHANGE<br>The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea. | Procedure: AMNIOECHANGE<br>* 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.<br>|
| No Intervention: placebo<br>This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true. | Procedure: AMNIOECHANGE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilation in the ICU and the duration of parenteral nutrition | The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition | 7 days and 45 days after the birth of the child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the contribution of iterative AMNIOECHANGE | Obstetric complications: chorioamnionitis, preterm labor, premature rupture of membranes, Aspect périviscérite, age out of intensive care and the initialization of enteral nutrition, infection Evaluation of complications of surgery, duration of hospitalization. And to determine prenatal prognostic factors: 1. Ultrasound 2. Biological and postnatal: Histology | 7 days, 45 days, 12 months and 18 months |