Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3

Conditions: Gastroschisis

Treatments: Procedure: AMNIOECHANGE

Study type: Interventional

Funder types: Other

Identifiers

NCT00127946

P040416

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

AMNIOECHANGE

Active Comparator group

Description:

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

Treatment:

Procedure: AMNIOECHANGE

placebo

No Intervention group

Description:

This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.

Treatment:

Procedure: AMNIOECHANGE