Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201656
Status:
TERMINATED
Last Update Posted:
2014-12-19
First Post:
2005-09-13
Brief Title:
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes PPROM
Sponsor:
Obstetrix Medical Group
Organization:
Pediatrix
Study Overview
Official Title:
Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This trial was terminated following a futility analysis confirming futility of continuing the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMCerclage
Brief Summary:
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
Detailed Description:
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 1-31000 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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OBX0002 | OTHER | Obstetrix CREQ Protocol Number | None |