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|ClinicalTrials.gov Identifier: NCT00787163|
Recruitment Status : Unknown
Verified November 2008 by Università degli Studi di Brescia.
Recruitment status was: Recruiting
First Posted : November 7, 2008
Last Update Posted : January 22, 2009
|Condition or disease||Intervention/treatment||Phase|
|Oligohydramnios||Procedure: amnioinfusion||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||December 2013|
serial amnioinfusions aimed at restoring amniotic fluid volume
No Intervention: 2
- Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management [ Time Frame: discharge of every neonate from NICU ]
- Gestational age of delivery (main secondary outcome) [ Time Frame: time of delivery for every case ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787163
|Contact: Anna Locatelli, MD||+39 039 233 firstname.lastname@example.org|
|University of Milano Bicocca, Ospedale san Gerardo Monza||Recruiting|
|Monza, Milano, Italy, 20052|
|Contact: Anna Locatelli, MD +390392334720 email@example.com|
|Principal Investigator:||Anna Locatelli, MD||University of Milano Bicocca|
|Study Chair:||Patrizia Vergani, MD||University of Milano Bicocca|