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

Fetal Membranes, Premature Rupture Clinical Trial

— PROMCerclage  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00201656
• Other study ID #: OBX0002
• Secondary ID: OBX0002
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: December 17, 2014
• Start date: November 2004
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Rupture

Intervention

Procedure:
• Retention of Cerclage
Retain Cerclage until clinical removal is indicated by protocol
• Removal of Cerclage
Immediate removal of Cerclage following randomization
• Removal vs. Retention of Cervical Cerclage
Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress

Locations

Country	Name	City	State
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	University of Illinois at Chicago	Chicago	Illinois
United States	The University Hospital	Cincinnati	Ohio
United States	Presbyterian/St Luke's Hospital	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	Swedish Medical Center	Denver	Colorado
United States	Hutzel Women's Hospital	Detroit	Michigan
United States	Sacred Heart Medical Center	Eugene	Oregon
United States	Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment	Houston	Texas
United States	Saint Luke's Hospital, Kansas City	Kansas City	Missouri
United States	Evergreen Hospital	Kirkland	Washington
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Sunrise Medical Center	Las Vegas	Nevada
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Desert Good Samaritan Hospital	Mesa	Arizona
United States	Yale New-Haven Medical Center	New Haven	Connecticut
United States	University of Southern California-Irvine Medical Center	Orange	California
United States	Banner Good Samaritan Hospital	Phoenix	Arizona
United States	University of Rochester Medical Center	Rochester	New York
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington
United States	Lousiana State University Health Science	Shreveport	Louisiana
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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

External Links

•   Protocols' home page on the sponsor's Web site. Click on Protocols and then click the Protocol "Removal vs. Retention of Cerclage in PPROM" for more information about this study.