Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

NCT00127946 | Unknown Phase 3

• 1 other identifier: P040416
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroschisis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the contribution of iterative AMNIOECHANGE

  7 days, 45 days, 12 months and 18 months

Study Arms (2)

AMNIOECHANGE

ACTIVE COMPARATOR

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

Procedure: AMNIOECHANGE

placebo

NO INTERVENTION

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

Procedure: AMNIOECHANGE

Interventions

AMNIOECHANGE PROCEDURE

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.

AMNIOECHANGE; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seen before 30 GA weeks
• Normal karyotype
• Single pregnancy
• Isolated gastroschisis
• No associated disease (maternal)
• Accept randomization and understand the study

You may not qualify if:

• Maternal diabetes
• Maternal infection with HIV, hepatitis

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre hospital, AP-HP

Paris, Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 31033140 DERIVED

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Luton, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 9, 2005
• Study Start: November 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 9, 2011

Record last verified: 2005-08

Locations

FR (1)