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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00127946 |
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:
Subject: 140 inclusion during 3 years
Analysis: Triangular Sequential Evaluation
Condition | Intervention |
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Gastroschisis |
Procedure: Amnioexchange |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment |
Official Title: | Randomized Trial of Amnioexchange in Gastroschisis Affected Foetuses |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dominique Luton, MD, PhD | dominique.luton@rdb.ap-hop-paris.fr |
Study Chair: | Dominique Luton, MD, PhD | Assistance Publique - Hôpitaux de Paris |
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 |
Pathological Conditions, Anatomical Musculoskeletal Diseases Hernia Hernia, Abdominal |
Gastroschisis Congenital Abnormalities Musculoskeletal Abnormalities |