Clinical trial NCT00201656: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fetal Membranes, Premature Rupture
Keywords: PPROM
Cerclage
Preterm Premature Rupture of the Membranes with Cerclage
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness
timeFrame: conception to birth
measure: Composite neonatal outcome - any one of the following (for twins, either infant): Fetal or neonatal death
timeFrame: Birth to 28days of life
measure: Respiratory distress syndrome
timeFrame: birth to 28days of life
measure: Documented sepsis within 72 hours of delivery
timeFrame: birth to 72 hours after delivery
measure: Grade 3 or 4 intraventricular hemorrhage
timeFrame: birth to 28days of life
measure: Stage 2 or 3 necrotizing enterocolitis
timeFrame: birth to 28days of life
measure: Neonatal intensive care unit (NICU) stay
timeFrame: birth to 28days of life
measure: Birth weight
timeFrame: at birth
measure: Estimated gestational age (EGA) at delivery
timeFrame: at delivery
measure: Postpartum endometritis
timeFrame: birth to 28days of life
measure: Maternal sepsis
timeFrame: birth to 28days following delivery
measure: Latency
timeFrame: labor to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Desert Good Samaritan Hospital
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Hospital
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Orange
country: United States
facility: University of Southern California-Irvine Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New-Haven Medical Center
state: Connecticut
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Shreveport
country: United States
facility: Lousiana State University Health Science
state: Louisiana
city: Detroit
country: United States
facility: Hutzel Women's Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital, Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Medical Center
state: Nevada
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: The University Hospital
state: Ohio
city: Eugene
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment
state: Texas
city: Kirkland
country: United States
facility: Evergreen Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Obstetrix Medical Group, Inc.
name: Kimberly Maurel, RN, MSN, CNS
role: STUDY_DIRECTOR
References:
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.
citation: American College of Obstetricians and Gynecologists. Preterm Labor. Technical Bulletin no. 206,1995.
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.
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.
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.
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.
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.