Clinical Trial: Amnioinfusion Initiative

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Università degli Studi di Brescia

Current Primary Outcome: Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management [ Time Frame: discharge of every neonate from NICU ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Gestational age of delivery (main secondary outcome) [ Time Frame: time of delivery for every case ]

Original Secondary Outcome: Same as current

Information By: Università degli Studi di Brescia

Dates:
Date Received: November 6, 2008
Date Started: September 2008
Date Completion: December 2013
Last Updated: January 21, 2009
Last Verified: November 2008