Expired Study
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Tucson, Arizona 85712


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

OBX0002


NCT ID:

NCT00201656


Secondary ID:

OBX0002


Study Acronym:

PROMCerclage


Brief Title:

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


Official Title:

Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mednax Center for Research, Education and Quality


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

This trial was terminated following a futili


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

58


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kimberly Maurel, RN, MSN, CNS
Study Director
Obstetrix Medical Group, Inc.

Study Dates

Start Date:November 2004
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:November 2013
Primary Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 17, 2014
First Received Date:September 13, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Procedure
Name:Retention of Cerclage
Description:Retain Cerclage until clinical removal is indicated by protocol
Arm Name:1 Retention of Cerclage
Intervention Type:Procedure
Name:Removal of Cerclage
Description:Immediate removal of Cerclage following randomization
Arm Name:2 - Removal of Cerclage
Intervention Type:Procedure
Name:Removal vs. Retention of Cervical Cerclage
Description:Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress
Arm Name:1 Retention of Cerclage
Other Name:McDonald or Shirodkar Cerclage

Study Arms

Study Arm Type:Active Comparator
Arm Name:1 Retention of Cerclage
Description:Group one = Subject whose Cerclage is retained after randomization.
Study Arm Type:Active Comparator
Arm Name:2 - Removal of Cerclage
Description:Group 2 = Subjects who will have cerclage removed after randomization

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Obstetrix Medical Group

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Naylor CS, Gregory K, Hobel C. Premature rupture of the membranes: an evidence-based approach to clinical care. Am J Perinatol. 2001 Nov;18(7):397-413. Review.
PMID:11731894
Reference Type:Reference
Citation:Ludmir J, Bader T, Chen L, Lindenbaum C, Wong G. Poor perinatal outcome associated with retained cerclage in patients with premature rupture of membranes. Obstet Gynecol. 1994 Nov;84(5):823-6.
PMID:7936520
Reference Type:Reference
Citation:Jenkins TM, Berghella V, Shlossman PA, McIntyre CJ, Maas BD, Pollock MA, Wapner RJ. Timing of cerclage removal after preterm premature rupture of membranes: maternal and neonatal outcomes. Am J Obstet Gynecol. 2000 Oct;183(4):847-52.
PMID:11035324
Reference Type:Reference
Citation:McElrath TF, Norwitz ER, Lieberman ES, Heffner LJ. Management of cervical cerclage and preterm premature rupture of the membranes: should the stitch be removed? Am J Obstet Gynecol. 2000 Oct;183(4):840-6.
PMID:11035323
Reference Type:Reference
Citation:American College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.
Reference Type:Reference
Citation:Treadwell MC, Bronsteen RA, Bottoms SF. Prognostic factors and complication rates for cervical cerclage: a review of 482 cases. Am J Obstet Gynecol. 1991 Sep;165(3):555-8.
PMID:1892180

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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