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Sponsors and Collaborators: |
Università degli Studi di Brescia Katholieke Universiteit Leuven University of Milan Catholic University, Italy Brescia University |
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Information provided by: | Università degli Studi di Brescia |
ClinicalTrials.gov Identifier: | NCT00787163 |
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.
Condition | Intervention | Phase |
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Oligohydramnios |
Procedure: amnioinfusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios |
Estimated Enrollment: | 82 |
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) |
Arms | Assigned Interventions |
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1: Experimental
amnioinfusion
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Procedure: amnioinfusion
serial amnioinfusions aimed at restoring amniotic fluid volume
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2: No Intervention
expectant management
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Locatelli, MD | +39 039 233 4720 | anna.locatelli@unimib.it |
Italy, Milano | |
University of Milano Bicocca, Ospedale san Gerardo Monza | Recruiting |
Monza, Milano, Italy, 20052 | |
Contact: Anna Locatelli, MD +390392334720 anna.locatelli@unimib.it |
Principal Investigator: | Anna Locatelli, MD | University of Milano Bicocca |
Study Chair: | Patrizia Vergani, MD | University of Milano Bicocca |
Responsible Party: | University of Milano Bicocca ( Anna Locatelli ) |
Study ID Numbers: | Amnioinfusion-001 |
Study First Received: | November 6, 2008 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00787163 History of Changes |
Health Authority: | Italy: Ethics Committee |
pPROM oligohydramnios amnioinfusion prematurity Early premature rupture of membranes in pregnancy |
Oligohydramnios Pregnancy Complications Rupture Fetal Membranes, Premature Rupture |
Oligohydramnios Pregnancy Complications |