NCT00787163

Amnioinfusion Initiative

Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.

Detailed description

Early spontaneous Preterm Premature Rupture of Membranes (PPROM) is associated with high perinatal mortality. Due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when PPROM occurs prior to 24 weeks. When oligohydramnios persists, it may raise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%. We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Inclusion criteria: Single pregnancy, early spontaneous PPROM \< 24.3 weeks, oligohydramnios (deepest vertical pocket \< 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.

Conditions

• Oligohydramnios

Interventions

Type	Name	Description
PROCEDURE	amnioinfusion	serial amnioinfusions aimed at restoring amniotic fluid volume

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-09-01
• Completion: 2013-12-01
• First posted: 2008-11-07
• Last updated: 2009-01-22

Locations

1 site across 1 country: Italy