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

This study has been terminated.
(This trial was terminated following a futility analysis confirming futility of continuing the study)
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT00201656
First received: September 13, 2005
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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
Fetal Membranes, Premature Rupture
Procedure: Retention of Cerclage
Procedure: Removal of Cerclage
Procedure: Removal vs. Retention of Cervical Cerclage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness [ Time Frame: conception to birth ] [ Designated as safety issue: Yes ]
  • Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death [ Time Frame: Birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Respiratory distress syndrome [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Documented sepsis within 72 hours of delivery [ Time Frame: birth to 72 hours after delivery ] [ Designated as safety issue: Yes ]
  • Grade 3 or 4 intraventricular hemorrhage [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Stage 2 or 3 necrotizing enterocolitis [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Neonatal intensive care unit (NICU) stay [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Birth weight [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
  • Estimated gestational age (EGA) at delivery [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
  • Postpartum endometritis [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ]
  • Maternal sepsis [ Time Frame: birth to 28days following delivery ] [ Designated as safety issue: Yes ]
  • Latency [ Time Frame: labor to delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 142
Study Start Date: November 2004
Estimated Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Retention of Cerclage
Group one = Subject whose Cerclage is retained after randomization.
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, chorioamnionitis, or fetal distress
Other Name: McDonald or Shirodkar Cerclage
Active Comparator: 2 - Removal of Cerclage
Group 2 = Subjects who will have cerclage removed after randomization
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, chorioamnionitis, or fetal distress
Other Name: McDonald or Shirodkar Cerclage

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 1-3/1000 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00201656

  Show 23 Study Locations
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Study Director: Kimberly Maurel, RN, MSN, CNS Obstetrix Medical Group, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00201656     History of Changes
Other Study ID Numbers: OBX0002, OBX0002
Study First Received: September 13, 2005
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
PPROM
Cerclage
Preterm Premature Rupture of the Membranes with Cerclage

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014