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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

September 13, 2005
December 13, 2013
November 2004
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • • chorioamnionitis as defined by temp > 38 plus fetal tachycardia or uterine tenderness
  • • Composite Neonatal Outcome – any one of the following (for twins, either infant) :
  • o Respiratory distress syndrome
  • o Documented sepsis within 72 hours of delivery
  • o Grade 3 or 4 intraventricular hemorrhage
  • o Stage 2 or 3 necrotizing enterocolitis
  • • NICU stay
  • • Birth weight
  • • EGA at delivery
  • • Postpartum endometritis
  • • Maternal sepsis
  • • Latency
  • o Fetal or neonatal death
Complete list of historical versions of study NCT00201656 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fetal Membranes, Premature Rupture
  • Procedure: Retention of Cerclage
    Retain Cerclage until clinical removal is indicated by protocol
  • 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
  • Active Comparator: 1 Retention of Cerclage
    Group one = Subject whose Cerclage is retained after randomization.
    Interventions:
    • Procedure: Retention of Cerclage
    • Procedure: Removal vs. Retention of Cervical Cerclage
  • Active Comparator: 2 - Removal of Cerclage
    Group 2 = Subjects who will have cerclage removed after randomization
    Interventions:
    • Procedure: Removal of Cerclage
    • Procedure: Removal vs. Retention of Cervical Cerclage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
142
April 2014
November 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201656
OBX0002, OBX0002
Yes
Obstetrix Medical Group
Obstetrix Medical Group
Not Provided
Study Director: Kimberly Maurel, RN, MSN, CNS Obstetrix Medical Group, Inc.
Obstetrix Medical Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP