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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.AJ

Abstract

OBJECTIVE

The decision of whether to retain or remove a previously placed cervical cerclage in women who subsequently rupture fetal membranes in a premature gestation is controversial and all studies to date are retrospective. We performed a multicenter randomized controlled trial of removal vs retention of cerclage in these patients to determine whether leaving the cerclage in place prolonged gestation and/or increased the risk of maternal or fetal infection.

STUDY DESIGN

A prospective randomized multicenter trial of 27 hospitals was performed. Patients included were those with cerclage placement at ≤23 weeks 6 days in singleton or twin pregnancies, with subsequent spontaneous rupture of membranes between 22 weeks 0 days and 32 weeks 6 days. Patients were randomized to retention or removal of cerclage. Patients were then expectantly managed and delivered only for evidence of labor, chorioamnionitis, fetal distress, or other medical or obstetrical indications. Management after 34 weeks was at the clinician's discretion.

RESULTS

The initial sample size calculation determined that a total of 142 patients should be included but after a second interim analysis, futility calculations determined that the conditional power for showing statistical significance after randomizing 142 patients for the primary outcome of prolonging pregnancy was 22.8%. Thus the study was terminated after a total of 56 subjects were randomized with complete data available for analysis, 32 to removal and 24 to retention of cerclage. There was no statistical significance in primary outcome of prolonging pregnancy by 1 week comparing the 2 groups (removal 18/32, 56.3%; retention 11/24, 45.8%) P = .59; or chorioamnionitis (removal 8/32, 25.0%; retention 10/24, 41.7%) P = .25, respectively. There was no statistical difference in composite neonatal outcomes (removal 16/33, 50%; retention 17/30, 56%), fetal/neonatal death (removal 4/33, 12%; retention 5/30, 16%); or gestational age at delivery (removal mean 200 days; retention mean 198 days).

CONCLUSION

Statistically significant differences were not seen in prolongation of latency, infection, or composite neonatal outcomes. However, there was a numerical trend in the direction of less infectious morbidity, with immediate removal of cerclage. These findings may not have met statistical significance if the original sample size of 142 was obtained, however they provide valuable data suggesting that there may be no advantage to retaining a cerclage after preterm premature rupture of membranes and a possibility of increased infection with cerclage retention.

Authors+Show Affiliations

Long Beach Memorial Medical Center, Long Beach, and Kaiser Permanente, Anaheim, CA.University of California Irvine, Orange, CA; Obstetrix/Pediatrix Medical Group, Sunrise, FL.Obstetrix/Pediatrix Medical Group, Sunrise, FL.Obstetrix/Pediatrix Medical Group, Sunrise, FL.Regional Obstetrical Consultants and University of Tennessee, Chattanooga, TN.Obstetrix Medical Group of Georgia, Decatur, GA.Obstetrix Medical Group, San Jose, CA.University of Cincinnati, Cincinnati, OH, and Norton Healthcare, Kosair Maternal-Fetal Medicine, Louisville, KY.High Risk Pregnancy Center, Las Vegas, NV.University of Illinois at Chicago, Chicago, IL.Obstetrix Medical Group, Kansas City, MO.Obstetrix Medical Group, Seattle, WA.Obstetrix Medical Group, Tucson, AZ.Long Beach Memorial Medical Center, Long Beach, and Kaiser Permanente, Anaheim, CA.University of Rochester, Rochester, NY.University of California Irvine, Orange, CA.Memorial Hermann Hospital, Houston, TX.Obstetrix Medical Group, Phoenix, AZ.Wayne State University, Detroit, MI.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24726507

Citation

Galyean, Anna, et al. "Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes: a Randomized Controlled Trial." American Journal of Obstetrics and Gynecology, vol. 211, no. 4, 2014, pp. 399.e1-7.
Galyean A, Garite TJ, Maurel K, et al. Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol. 2014;211(4):399.e1-7.
Galyean, A., Garite, T. J., Maurel, K., Abril, D., Adair, C. D., Browne, P., Combs, C. A., How, H., Iriye, B. K., Kominiarek, M., Lu, G., Luthy, D., Miller, H., Nageotte, M., Ozcan, T., Porto, M., Ramirez, M., Sawai, S., & Sorokin, Y. (2014). Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial. American Journal of Obstetrics and Gynecology, 211(4), e1-7. https://doi.org/10.1016/j.ajog.2014.04.009
Galyean A, et al. Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes: a Randomized Controlled Trial. Am J Obstet Gynecol. 2014;211(4):399.e1-7. PubMed PMID: 24726507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial. AU - Galyean,Anna, AU - Garite,Thomas J, AU - Maurel,Kimberly, AU - Abril,Diana, AU - Adair,Charles D, AU - Browne,Paul, AU - Combs,C Andrew, AU - How,Helen, AU - Iriye,Brian K, AU - Kominiarek,Michelle, AU - Lu,George, AU - Luthy,David, AU - Miller,Hugh, AU - Nageotte,Michael, AU - Ozcan,Tulin, AU - Porto,Manuel, AU - Ramirez,Mildred, AU - Sawai,Shirley, AU - Sorokin,Yoram, AU - ,, Y1 - 2014/04/12/ PY - 2014/02/20/received PY - 2014/03/18/revised PY - 2014/04/07/accepted PY - 2014/4/15/entrez PY - 2014/4/15/pubmed PY - 2014/12/15/medline KW - cerclage KW - chorioamnionitis KW - latency KW - preterm premature rupture of membranes SP - 399.e1 EP - 7 JF - American journal of obstetrics and gynecology JO - Am. J. Obstet. Gynecol. VL - 211 IS - 4 N2 - OBJECTIVE: The decision of whether to retain or remove a previously placed cervical cerclage in women who subsequently rupture fetal membranes in a premature gestation is controversial and all studies to date are retrospective. We performed a multicenter randomized controlled trial of removal vs retention of cerclage in these patients to determine whether leaving the cerclage in place prolonged gestation and/or increased the risk of maternal or fetal infection. STUDY DESIGN: A prospective randomized multicenter trial of 27 hospitals was performed. Patients included were those with cerclage placement at ≤23 weeks 6 days in singleton or twin pregnancies, with subsequent spontaneous rupture of membranes between 22 weeks 0 days and 32 weeks 6 days. Patients were randomized to retention or removal of cerclage. Patients were then expectantly managed and delivered only for evidence of labor, chorioamnionitis, fetal distress, or other medical or obstetrical indications. Management after 34 weeks was at the clinician's discretion. RESULTS: The initial sample size calculation determined that a total of 142 patients should be included but after a second interim analysis, futility calculations determined that the conditional power for showing statistical significance after randomizing 142 patients for the primary outcome of prolonging pregnancy was 22.8%. Thus the study was terminated after a total of 56 subjects were randomized with complete data available for analysis, 32 to removal and 24 to retention of cerclage. There was no statistical significance in primary outcome of prolonging pregnancy by 1 week comparing the 2 groups (removal 18/32, 56.3%; retention 11/24, 45.8%) P = .59; or chorioamnionitis (removal 8/32, 25.0%; retention 10/24, 41.7%) P = .25, respectively. There was no statistical difference in composite neonatal outcomes (removal 16/33, 50%; retention 17/30, 56%), fetal/neonatal death (removal 4/33, 12%; retention 5/30, 16%); or gestational age at delivery (removal mean 200 days; retention mean 198 days). CONCLUSION: Statistically significant differences were not seen in prolongation of latency, infection, or composite neonatal outcomes. However, there was a numerical trend in the direction of less infectious morbidity, with immediate removal of cerclage. These findings may not have met statistical significance if the original sample size of 142 was obtained, however they provide valuable data suggesting that there may be no advantage to retaining a cerclage after preterm premature rupture of membranes and a possibility of increased infection with cerclage retention. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/24726507/Removal_versus_retention_of_cerclage_in_preterm_premature_rupture_of_membranes:_a_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(14)00347-0 DB - PRIME DP - Unbound Medicine ER -