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

Primary Purpose

Fetal Membranes, Premature Rupture

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Retention of Cerclage
Removal of Cerclage
Removal vs. Retention of Cervical Cerclage
Sponsored by
Obstetrix Medical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Membranes, Premature Rupture focused on measuring PPROM, Cerclage, Preterm Premature Rupture of the Membranes with Cerclage

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Spontaneous rupture of membranes 22-32 weeks Singleton or twin gestation Shirodkar or McDonald cerclage in place > 1 week Exclusion Criteria: Active labor (> 8 uterine contractions [UCs] per hour) Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness Placenta previa or undiagnosed vaginal bleeding Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP) Mature pulmonary studies Positive gram stain, culture, white blood cells (WBC) > 30, or glucose < 14 on amniocentesis Major fetal anomaly Presentation > 48 hours after rupture of membranes abdominal cerclage Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm) Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)

Sites / Locations

  • Desert Good Samaritan Hospital
  • Banner Good Samaritan Hospital
  • Tucson Medical Center
  • Saddleback Memorial Medical Center
  • Long Beach Memorial Medical Center
  • University of Southern California-Irvine Medical Center
  • Good Samaritan Hospital
  • Swedish Medical Center
  • Presbyterian/St Luke's Hospital
  • Rose Medical Center
  • Yale New-Haven Medical Center
  • University of Illinois at Chicago
  • Lousiana State University Health Science
  • Hutzel Women's Hospital
  • Saint Luke's Hospital, Kansas City
  • Sunrise Medical Center
  • University of Rochester Medical Center
  • The University Hospital
  • Sacred Heart Medical Center
  • Erlanger Medical Center
  • Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment
  • Evergreen Hospital
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 Retention of Cerclage

2 - Removal of Cerclage

Arm Description

Group one = Subject whose Cerclage is retained after randomization.

Group 2 = Subjects who will have cerclage removed after randomization

Outcomes

Primary Outcome Measures

Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness
Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death
Respiratory distress syndrome
Documented sepsis within 72 hours of delivery
Grade 3 or 4 intraventricular hemorrhage
Stage 2 or 3 necrotizing enterocolitis
Neonatal intensive care unit (NICU) stay
Birth weight
Estimated gestational age (EGA) at delivery
Postpartum endometritis
Maternal sepsis
Latency

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
December 17, 2014
Sponsor
Obstetrix Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT00201656
Brief Title
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
Acronym
PROMCerclage
Official Title
Removal Versus Retention of Cervical Cerclage in Preterm Premature Rupture of Membranes-A Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
This trial was terminated following a futility analysis confirming futility of continuing the study
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Obstetrix Medical Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Membranes, Premature Rupture
Keywords
PPROM, Cerclage, Preterm Premature Rupture of the Membranes with Cerclage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Retention of Cerclage
Arm Type
Active Comparator
Arm Description
Group one = Subject whose Cerclage is retained after randomization.
Arm Title
2 - Removal of Cerclage
Arm Type
Active Comparator
Arm Description
Group 2 = Subjects who will have cerclage removed after randomization
Intervention Type
Procedure
Intervention Name(s)
Retention of Cerclage
Intervention Description
Retain Cerclage until clinical removal is indicated by protocol
Intervention Type
Procedure
Intervention Name(s)
Removal of Cerclage
Intervention Description
Immediate removal of Cerclage following randomization
Intervention Type
Procedure
Intervention Name(s)
Removal vs. Retention of Cervical Cerclage
Other Intervention Name(s)
McDonald or Shirodkar Cerclage
Intervention Description
Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress
Primary Outcome Measure Information:
Title
Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness
Time Frame
conception to birth
Title
Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death
Time Frame
Birth to 28days of life
Title
Respiratory distress syndrome
Time Frame
birth to 28days of life
Title
Documented sepsis within 72 hours of delivery
Time Frame
birth to 72 hours after delivery
Title
Grade 3 or 4 intraventricular hemorrhage
Time Frame
birth to 28days of life
Title
Stage 2 or 3 necrotizing enterocolitis
Time Frame
birth to 28days of life
Title
Neonatal intensive care unit (NICU) stay
Time Frame
birth to 28days of life
Title
Birth weight
Time Frame
at birth
Title
Estimated gestational age (EGA) at delivery
Time Frame
at delivery
Title
Postpartum endometritis
Time Frame
birth to 28days of life
Title
Maternal sepsis
Time Frame
birth to 28days following delivery
Title
Latency
Time Frame
labor to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Spontaneous rupture of membranes 22-32 weeks Singleton or twin gestation Shirodkar or McDonald cerclage in place > 1 week Exclusion Criteria: Active labor (> 8 uterine contractions [UCs] per hour) Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness Placenta previa or undiagnosed vaginal bleeding Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP) Mature pulmonary studies Positive gram stain, culture, white blood cells (WBC) > 30, or glucose < 14 on amniocentesis Major fetal anomaly Presentation > 48 hours after rupture of membranes abdominal cerclage Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm) Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Maurel, RN, MSN, CNS
Organizational Affiliation
Obstetrix Medical Group, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Desert Good Samaritan Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Banner Good Samaritan Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Saddleback Memorial Medical Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
University of Southern California-Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Swedish Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Presbyterian/St Luke's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Yale New-Haven Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Lousiana State University Health Science
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
60612
Country
United States
Facility Name
Hutzel Women's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint Luke's Hospital, Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Sunrise Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Sacred Heart Medical Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Evergreen Hospital
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1892180
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. doi: 10.1016/0002-9378(91)90283-w.
Results Reference
background
Citation
American College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.
Results Reference
background
PubMed Identifier
11035323
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. doi: 10.1067/mob.2000.108870.
Results Reference
background
PubMed Identifier
11035324
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. doi: 10.1067/mob.2000.109039.
Results Reference
background
PubMed Identifier
7936520
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.
Results Reference
background
PubMed Identifier
11731894
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. doi: 10.1055/s-2001-18699. Erratum In: Am Fam Physician. 2015 Jun 1;91(11):750.
Results Reference
background
PubMed Identifier
24726507
Citation
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.
Results Reference
derived

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

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