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PPROMCerclage




Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes


Go to the PPROMCerclage website.



Objective
The question of whether to remove cerclage after preterm premature rupture of membranes (PPROM) is one of the unresolved controversies in obstetrics. It is unclear whether latency (the interval from membrane rupture to the onset of labor) is prolonged with retention of the suture. Furthermore, some studies suggest an increase in major infectious maternal morbidity and possibly neonatal morbidity. The objective of this study is to determine whether retention of cerclage after PPROM reduces chorioamnionitis, improves latency (without a significant increase in chorioamnionitis), and lessens neonatal morbidity.

Study design
Randomized trial performed in all ten perinatal centers in The Netherlands.

Study population
Women with PPROM and cerclage between 22+0/7 32+6/7 weeks  gestational age.

Intervention
Random allocation to retention of cerclage or immediate removal of cerclage.

Outcome measures
Latency, chorioamnionitis as defined by temp > 38C plus fetal tachycardia or uterine tenderness, Composite Neonatal Outcome, NICU stay, birth weight, estimated gestational age at delivery, postpartum endometritis and maternal sepsis.

Power/data analysis
The study will be evaluated according to intention to treat. Power Analysis is based on an estimated 22% rate of chorioamnionitis in PPROM patients.  A doubling of this rate to 44% should occur in a total of 142 subjects (71 in each arm).  Similarly, the rate of patients remaining undelivered at 1 week is 50%.  To achieve a 50% increase in the number of patients achieving one week undelivered is virtually identical (140).  This study will have a 1:1 case-control ratio, 80% power, and p of 0.05. Of these 142 subjects, 40 inclusions will be in the Netherlands and 102 in the United States and Mexico

Time schedule
Start in 2012

Projectleaders
Prof. dr. B.W. Mol, gynaecologist and clinical epidemiologist, AMC Amsterdam

Contact
T.S. de Lange
Ziekenhuis/centrum: Academisch Medisch Centrum
Telefoonnummer: +31 6 48276645
delangets@gmail.com