|- candidate number||13338|
|- NTR Number||NTR3621|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2012|
|- Secondary IDs||NL36460.018.12 / 2012_128; CCMO / MEC AMC|
|- Public Title||Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes.|
|- Scientific Title||Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Premature Preterm Rupture Of Membranes|
|- Inclusion criteria||1. A previously placed prophylactic cerclage defined as any cerclage done ≤ 23+6/7 weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation ≤ 3 cm;|
2. Spontaneous rupture of membranes 22+0/7 ¨C 32+6/7 weeks;
3. Singleton or twin gestation;
4. Shirodkar or McDonald cerclage in place ≥ 1 week.
|- Exclusion criteria||1. Active labor (>8 uterine contractions per hour);|
2. Chorioamnionitis as defined by temp > 38oC plus fetal tachycardia or uterine tenderness;
3. Placenta previa or undiagnosed vaginal bleeding;
4. Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP);
5. Presentation > 48 hours after rupture of membranes;
6. Abdominal cerclage;
7. Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm);
8. Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-aug-2015|
|- Target number of participants||142|
|- Interventions||Random allocation to retention of cerclage or immediate removal of cerclage.|
|- Primary outcome||To determine whether retention of cerclage after PPROM improves in terms of:|
1. Chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);
2. Latency (the interval from membrane rupture to the onset of labor in days) without a significant increase in chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);
3. Composite Neonatal Outcome:
A. Fetal or neonatal death;
B. Respiratory distress syndrome;
C. Documented sepsis within 72 hours of delivery;
D. Grade 3 or 4 intraventricular hemorrhage;
E. Stage 2 or 3 necrotizing enterocolitis.
|- Secondary outcome||To compare these treatments in terms of:|
1. NICU stay;
2. Birth weight;
3. Estimated gestational age at delivery;
4. Postpartum endometritis;
5. Maternal sepsis.
|- Timepoints||In view of the relatively small sample size, the fact that both treatments are already applied and are both mentioned in the Dutch guidelines, an interim analysis is not planned.|
|- Trial web site||www.studies-obsgyn.nl/ppromcerclage|
|- CONTACT FOR PUBLIC QUERIES|| T.S. Lange, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. B.W.M. Mol|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale: |
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.
Main study parameters/endpoints:
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.
|- Main changes (audit trail)|
|- RECORD||19-sep-2012 - 27-sep-2012|