Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Gastroschisis Clinical Trial

— AMNIOECHANGE  

Official title:

Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00127946
• Other study ID #: P040416
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: August 8, 2011
• Start date: November 2005
• Est. completion date: April 2012

Study information

• Verified date: August 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroschisis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Robert Debre hospital, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No