Study Stopped
This trial was terminated following a futility analysis confirming futility of continuing the study
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
PROMCerclage
1 other identifier
interventional
58
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2004
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedDecember 19, 2014
December 1, 2014
9 years
September 13, 2005
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness
conception to birth
Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death
Birth to 28days of life
Respiratory distress syndrome
birth to 28days of life
Documented sepsis within 72 hours of delivery
birth to 72 hours after delivery
Grade 3 or 4 intraventricular hemorrhage
birth to 28days of life
Stage 2 or 3 necrotizing enterocolitis
birth to 28days of life
Neonatal intensive care unit (NICU) stay
birth to 28days of life
Birth weight
at birth
Estimated gestational age (EGA) at delivery
at delivery
Postpartum endometritis
birth to 28days of life
Maternal sepsis
birth to 28days following delivery
Latency
labor to delivery
Study Arms (2)
1 Retention of Cerclage
ACTIVE COMPARATORGroup one = Subject whose Cerclage is retained after randomization.
2 - Removal of Cerclage
ACTIVE COMPARATORGroup 2 = Subjects who will have cerclage removed after randomization
Interventions
Retain Cerclage until clinical removal is indicated by protocol
Immediate removal of Cerclage following randomization
Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Desert Good Samaritan Hospital
Mesa, Arizona, 85202, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428, United States
University of Southern California-Irvine Medical Center
Orange, California, 92868, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Swedish Medical Center
Denver, Colorado, 80110, United States
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Yale New-Haven Medical Center
New Haven, Connecticut, 06504, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Lousiana State University Health Science
Shreveport, Louisiana, 60612, United States
Hutzel Women's Hospital
Detroit, Michigan, 48201, United States
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, 64111, United States
Sunrise Medical Center
Las Vegas, Nevada, 89109, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
The University Hospital
Cincinnati, Ohio, 45219, United States
Sacred Heart Medical Center
Eugene, Oregon, 97401, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment
Houston, Texas, 77030, United States
Evergreen Hospital
Kirkland, Washington, 98034, United States
Swedish Medical Center
Seattle, Washington, 98122-4307, United States
Related Publications (7)
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.
PMID: 1892180BACKGROUNDAmerican College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.
BACKGROUNDMcElrath 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.
PMID: 11035323BACKGROUNDJenkins 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.
PMID: 11035324BACKGROUNDLudmir 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: 7936520BACKGROUNDNaylor 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.
PMID: 11731894BACKGROUNDGalyean 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.
PMID: 24726507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kimberly Maurel, RN, MSN, CNS
Obstetrix Medical Group, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
November 1, 2004
Primary Completion
November 1, 2013
Study Completion
April 1, 2014
Last Updated
December 19, 2014
Record last verified: 2014-12