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Trial of Amnioexchange in Gastroschisis Affected Foetuses
This study is not yet open for participant recruitment.
Verified by Assistance Publique - Hôpitaux de Paris, August 2005
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00127946
  Purpose

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. amnioexchange) would improve the outcome of theses fetuses and then neonates.

Primary Objective: To compare prospectively the effect of amnioexchange against classical care on the delay of full enteral feeding in gastroschisis affected foetuses

Study:

  • Multicenter, Randomized.
  • Inclusion at 20 GA (gestational age) weeks.
  • Amnioexchange every 2 weeks from 30 GA weeks

Subject: 140 inclusion during 3 years

Analysis: Triangular Sequential Evaluation


Condition Intervention
Gastroschisis
Procedure: Amnioexchange

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment
Official Title: Randomized Trial of Amnioexchange in Gastroschisis Affected Foetuses
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127946

Contacts
Contact: Dominique Luton, MD, PhD dominique.luton@rdb.ap-hop-paris.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Dominique Luton, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Study ID Numbers: HParis, PHRC2005
Study First Received: August 8, 2005
Last Updated: August 29, 2005
ClinicalTrials.gov Identifier: NCT00127946  
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Hernia
Hernia, Abdominal
Gastroschisis
Congenital Abnormalities
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009