Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00127946
• Date of registration: 08/08/2005
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses AMNIOECHANGE
• Scientific title: Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
• Date of first enrolment: November 2005
• Target sample size: 140
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00127946
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Dominique Luton, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Gastroschisis

Intervention(s)

Procedure: AMNIOECHANGE

Primary Outcome(s)

Duration of ventilation in the ICU and the duration of parenteral nutrition [Time Frame: 7 days and 45 days after the birth of the child]

Secondary Outcome(s)

Evaluation of the contribution of iterative AMNIOECHANGE [Time Frame: 7 days, 45 days, 12 months and 18 months]

Secondary ID(s)

P040416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors