Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses (AMNIOECHANGE)

Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

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.

Study Overview

• Status: Unknown
• Conditions: Gastroschisis
• Intervention / Treatment: Procedure: AMNIOECHANGE

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

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital, AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Dominique Luton, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: August 8, 2005
• First Submitted That Met QC Criteria: August 8, 2005
• First Posted (Estimate): August 9, 2005

Study Record Updates

• Last Update Posted (Estimate): August 9, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Gastroschisis
• Other Study ID Numbers: P040416