Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM) (PROMCerclage)

Obstetrix Medical Group

Status and phase: Terminated; Phase 4

Conditions: Fetal Membranes, Premature Rupture

Treatments: Procedure: Removal of Cerclage; Procedure: Retention of Cerclage; Procedure: Removal vs. Retention of Cervical Cerclage

Study type: Interventional

Funder types: Industry

Identifiers

NCT00201656

OBX0002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 1-3/1000 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.

Enrollment: 58 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 22-32 weeks
3. Singleton or twin gestation
4. Shirodkar or McDonald cerclage in place > 1 week

Exclusion criteria

1. Active labor (> 8 uterine contractions [UCs] per hour)
2. Chorioamnionitis as defined by temperature > 38 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. Mature pulmonary studies
6. Positive gram stain, culture, white blood cells (WBC) > 30, or glucose < 14 on amniocentesis
7. Major fetal anomaly
8. Presentation > 48 hours after rupture of membranes
9. abdominal cerclage
10. Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm)
11. Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

1 Retention of Cerclage

Active Comparator group

Description:

Group one = Subject whose Cerclage is retained after randomization.

Treatment:

Procedure: Removal vs. Retention of Cervical Cerclage

Procedure: Retention of Cerclage

2 - Removal of Cerclage

Active Comparator group

Description:

Group 2 = Subjects who will have cerclage removed after randomization

Treatment:

Procedure: Removal vs. Retention of Cervical Cerclage

Procedure: Removal of Cerclage