Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses (AMNIOECHANGE)

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.

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

The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.

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.

The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition

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

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

Luton D, Mitanchez D, Winer N, Muller F, Gallot D, Perrotin F, Jouannic JM, Bretelle F, de Lagausie P, Ville Y, Guibourdenche J, Oury JF, Alberti C, Benachi A. A randomised controlled trial of amnioexchange for fetal gastroschisis. BJOG. 2019 Sep;126(10):1233-1241. doi: 10.1111/1471-0528.15804. Epub 2019 May 20.