Gastroschisis
Conditions
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 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
Interventions
PROCEDUREAMNIOECHANGE
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ventilation in the ICU and the duration of parenteral nutrition | 7 days and 45 days after the birth of the child | The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the contribution of iterative AMNIOECHANGE | 7 days, 45 days, 12 months and 18 months | * 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 |
Countries
France
Outcome results
None listed