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

NCT ID: NCT00201656

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Fetal Membranes, Premature Rupture

Keywords

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PPROM Cerclage Preterm Premature Rupture of the Membranes with Cerclage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Retention of Cerclage

Group one = Subject whose Cerclage is retained after randomization.

Group Type ACTIVE_COMPARATOR

Retention of Cerclage

Intervention Type PROCEDURE

Retain Cerclage until clinical removal is indicated by protocol

Removal vs. Retention of Cervical Cerclage

Intervention Type PROCEDURE

Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress

2 - Removal of Cerclage

Group 2 = Subjects who will have cerclage removed after randomization

Group Type ACTIVE_COMPARATOR

Removal of Cerclage

Intervention Type PROCEDURE

Immediate removal of Cerclage following randomization

Removal vs. Retention of Cervical Cerclage

Intervention Type PROCEDURE

Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress

Interventions

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Retention of Cerclage

Retain Cerclage until clinical removal is indicated by protocol

Intervention Type PROCEDURE

Removal of Cerclage

Immediate removal of Cerclage following randomization

Intervention Type PROCEDURE

Removal vs. Retention of Cervical Cerclage

Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress

Intervention Type PROCEDURE

Other Intervention Names

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McDonald or Shirodkar Cerclage

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Obstetrix Medical Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Maurel, RN, MSN, CNS

Role: STUDY_DIRECTOR

Obstetrix Medical Group, Inc.

Locations

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Desert Good Samaritan Hospital

Mesa, Arizona, United States

Site Status

Banner Good Samaritan Hospital

Phoenix, Arizona, United States

Site Status

Tucson Medical Center

Tucson, Arizona, United States

Site Status

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

University of Southern California-Irvine Medical Center

Orange, California, United States

Site Status

Good Samaritan Hospital

San Jose, California, United States

Site Status

Swedish Medical Center

Denver, Colorado, United States

Site Status

Presbyterian/St Luke's Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Yale New-Haven Medical Center

New Haven, Connecticut, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Lousiana State University Health Science

Shreveport, Louisiana, United States

Site Status

Hutzel Women's Hospital

Detroit, Michigan, United States

Site Status

Saint Luke's Hospital, Kansas City

Kansas City, Missouri, United States

Site Status

Sunrise Medical Center

Las Vegas, Nevada, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

The University Hospital

Cincinnati, Ohio, United States

Site Status

Sacred Heart Medical Center

Eugene, Oregon, United States

Site Status

Erlanger Medical Center

Chattanooga, Tennessee, United States

Site Status

Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment

Houston, Texas, United States

Site Status

Evergreen Hospital

Kirkland, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/0002-9378(91)90283-w.

Reference Type BACKGROUND
PMID: 1892180 (View on PubMed)

American College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.

Reference Type BACKGROUND

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. doi: 10.1067/mob.2000.108870.

Reference Type BACKGROUND
PMID: 11035323 (View on PubMed)

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. doi: 10.1067/mob.2000.109039.

Reference Type BACKGROUND
PMID: 11035324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7936520 (View on PubMed)

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. doi: 10.1055/s-2001-18699.

Reference Type BACKGROUND
PMID: 11731894 (View on PubMed)

Galyean A, Garite TJ, Maurel K, Abril D, Adair CD, Browne P, Combs CA, How H, Iriye BK, Kominiarek M, Lu G, Luthy D, Miller H, Nageotte M, Ozcan T, Porto M, Ramirez M, Sawai S, Sorokin Y; Obstetrix Perinatal Collaborative Research Network. Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol. 2014 Oct;211(4):399.e1-7. doi: 10.1016/j.ajog.2014.04.009. Epub 2014 Apr 12.

Reference Type DERIVED
PMID: 24726507 (View on PubMed)

Other Identifiers

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OBX0002

Identifier Type: OTHER

Identifier Source: secondary_id

OBX0002

Identifier Type: -

Identifier Source: org_study_id