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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios|
- Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management [ Time Frame: discharge of every neonate from NICU ] [ Designated as safety issue: Yes ]
- Gestational age of delivery (main secondary outcome) [ Time Frame: time of delivery for every case ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
serial amnioinfusions aimed at restoring amniotic fluid volume
No Intervention: 2
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.
|Contact: Anna Locatelli, MD||+39 039 233 email@example.com|
|University of Milano Bicocca, Ospedale san Gerardo Monza||Recruiting|
|Monza, Milano, Italy, 20052|
|Contact: Anna Locatelli, MD +390392334720 firstname.lastname@example.org|
|Principal Investigator:||Anna Locatelli, MD||University of Milano Bicocca|
|Study Chair:||Patrizia Vergani, MD||University of Milano Bicocca|