Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes
Go to the PPROMCerclage website.
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.
Randomized trial performed in all ten perinatal centers in The Netherlands.
Women with PPROM and cerclage between 22+0/7 – 32+6/7 weeks gestational age.
Random allocation to retention of cerclage or immediate removal of cerclage.
Latency, chorioamnionitis as defined by temp > 38°C plus fetal tachycardia or uterine tenderness, Composite Neonatal Outcome, NICU stay, birth weight, estimated gestational age at delivery, postpartum endometritis and maternal sepsis.
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
Start in 2012
Prof. dr. B.W. Mol, gynaecologist and clinical epidemiologist, AMC Amsterdam
T.S. de Lange
Ziekenhuis/centrum: Academisch Medisch Centrum
Telefoonnummer: +31 6 48276645