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Sponsored by: |
Obstetrix Medical Group |
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Information provided by: | Obstetrix Medical Group |
ClinicalTrials.gov Identifier: | NCT00201656 |
The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
Condition | Intervention | Phase |
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Fetal Membranes, Premature Rupture |
Procedure: Retention of Cerclage Procedure: Removal of Cerclage Procedure: Removal vs. Retention of Cervical Cerclage |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial |
Estimated Enrollment: | 142 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Retention of Cerclage: Active Comparator
Group one = Subject whose Cerclage is retained after randomization.
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Procedure: Retention of Cerclage
Retain Cerclage until clinical removal is indicated by protocol
Procedure: Removal vs. Retention of Cervical Cerclage
Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorio, or fetal distress
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2 - Removal of Cerclage: Active Comparator
Group 2 = Subjects who will have cerclage removed after randomization
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Procedure: Removal of Cerclage
Immediate removal of Cerclage following randomization
Procedure: Removal vs. Retention of Cervical Cerclage
Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorio, or fetal distress
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The placement of cervical cerclage is standard of care for women who experience incompetent cervix. Treadwell et al, published the largest retrospective review of 482 patients receiving cerclage (364 elective and 118 emergent). They found premature rupture of membranes (PROM) in 38% of the subjects with 9% delivering <27 weeks. Preterm birth is the cause of at least 75% of neonatal deaths that are not due to congenital malformations. The question of whether to remove cerclage after preterm premature rupture of membranes (PPROM) is one of the unresolved controversies in obstetrics because the few available studies are retrospective, all have small numbers of patients, and the studies have given conflicting results regarding the safety of retaining a cerclage after preterm premature rupture of the membranes. It is unclear from the retrospective studies whether latency (the interval from membrane rupture to the onset of labor) is prolonged with retention of the suture. Furthermore, some, but not all studies suggest an increase in major infectious maternal morbidity and possibly neonatal morbidity. For this reason, clinicians vary greatly in deciding on whether to remove a cerclage in a patient with PPROM and either practice is currently an acceptable standard. This is a fairly rare complication, the combination of PPROM in a patient with cerclage in place only occurs in about 1-3/1000 pregnant women. Thus it has been impossible to study this problem prospectively in any single institution. The establishment of the Obstetrix Collaborative Research Group affords the unique opportunity to study this rare complication. Obstetrix manages 19 practices of Perinatologists around the U.S. and Mexico and is comprised of nearly 100 such subspecialists. This problem is most often referred to a Perinatologist when it occurs, so it is not unusual for these practices to see 5 - 10 such patients per year. Obstetrix fully funds the infrastructure of this research group and inclusion in this study will not alter the cost of patient care in either group as there is virtually no cost in removing the cerclage and all these patients are kept in hospital until delivery when membranes rupture as standard of care.
This is a multicenter trial. The purpose is to determine whether retention of cerclage after preterm premature rupture of the membranes improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberly Maurel, MSN | 714-593-9171 | kimberly_maurel@pediatrix.com |
Contact: Diana Abril, BSN | 480-659-8644 | diana_abril@pediatrix.com |
Study Director: | Kimberly Maurel, RN, MSN, CNS | Obstetrix Medical Group, Inc. |
Responsible Party: | Obstetrix Medical Group, Inc. ( Kimberly Maurel ) |
Study ID Numbers: | OBX0002, OBX0002 |
Study First Received: | September 13, 2005 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00201656 History of Changes |
Health Authority: | United States: Institutional Review Board |
PPROM Cerclage Preterm Premature Rupture of the Membranes with Cerclage |
Pregnancy Complications Wounds and Injuries Obstetric Labor Complications Disorders of Environmental Origin |
Rupture Urinary Retention Fetal Membranes, Premature Rupture |
Pregnancy Complications Wounds and Injuries Obstetric Labor Complications |
Disorders of Environmental Origin Rupture Fetal Membranes, Premature Rupture |