Removal versus retention of cerclage in preterm premature rupture of membranes

A randomized controlled trial

Anna Galyean, Thomas J. Garite, Kimberly Maurel, Diana Abril, Charles D. Adair, Paul Christopher Browne, C. Andrew Combs, Helen How, Brian K. Iriye, Michelle Kominiarek, George Lu, David Luthy, Hugh Miller, Michael Nageotte, Tulin Ozcan, Manuel Porto, Mildred Ramirez, Shirley Sawai, Yoram Sorokin

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)399.e1-399.e7
JournalAmerican Journal of Obstetrics and Gynecology
Volume211
Issue number4
DOIs
StatePublished - Oct 1 2014
Externally publishedYes

Fingerprint

Randomized Controlled Trials
Chorioamnionitis
Pregnancy Outcome
Sample Size
Infection
Cervical Cerclage
Medical Futility
Extraembryonic Membranes
Pregnancy
Fetal Distress
Twin Pregnancy
Spontaneous Rupture
Fetal Death
Gestational Age
Multicenter Studies
Preterm Premature Rupture of the Membranes
Rupture
Mothers
Morbidity
Membranes

Keywords

  • cerclage
  • chorioamnionitis
  • latency
  • preterm premature rupture of membranes

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Galyean, A., Garite, T. J., Maurel, K., Abril, D., Adair, C. D., Browne, P. C., ... 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), 399.e1-399.e7. https://doi.org/10.1016/j.ajog.2014.04.009

Removal versus retention of cerclage in preterm premature rupture of membranes : A randomized controlled trial. / Galyean, Anna; Garite, Thomas J.; Maurel, Kimberly; Abril, Diana; Adair, Charles D.; Browne, Paul Christopher; Combs, C. Andrew; How, Helen; Iriye, Brian K.; Kominiarek, Michelle; Lu, George; Luthy, David; Miller, Hugh; Nageotte, Michael; Ozcan, Tulin; Porto, Manuel; Ramirez, Mildred; Sawai, Shirley; Sorokin, Yoram.

In: American Journal of Obstetrics and Gynecology, Vol. 211, No. 4, 01.10.2014, p. 399.e1-399.e7.

Research output: Contribution to journalArticle

Galyean, A, Garite, TJ, Maurel, K, Abril, D, Adair, CD, Browne, PC, 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 2014, '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, pp. 399.e1-399.e7. https://doi.org/10.1016/j.ajog.2014.04.009
Galyean, Anna ; Garite, Thomas J. ; Maurel, Kimberly ; Abril, Diana ; Adair, Charles D. ; Browne, Paul Christopher ; Combs, C. Andrew ; How, Helen ; Iriye, Brian K. ; Kominiarek, Michelle ; Lu, George ; Luthy, David ; Miller, Hugh ; Nageotte, Michael ; Ozcan, Tulin ; Porto, Manuel ; Ramirez, Mildred ; Sawai, Shirley ; Sorokin, Yoram. / Removal versus retention of cerclage in preterm premature rupture of membranes : A randomized controlled trial. In: American Journal of Obstetrics and Gynecology. 2014 ; Vol. 211, No. 4. pp. 399.e1-399.e7.
@article{06a280271cea49f495525a6099964ba7,
title = "Removal versus retention of cerclage in preterm premature rupture of membranes: A randomized controlled trial",
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.",
keywords = "cerclage, chorioamnionitis, latency, preterm premature rupture of membranes",
author = "Anna Galyean and Garite, {Thomas J.} and Kimberly Maurel and Diana Abril and Adair, {Charles D.} and Browne, {Paul Christopher} and Combs, {C. Andrew} and Helen How and Iriye, {Brian K.} and Michelle Kominiarek and George Lu and David Luthy and Hugh Miller and Michael Nageotte and Tulin Ozcan and Manuel Porto and Mildred Ramirez and Shirley Sawai and Yoram Sorokin",
year = "2014",
month = "10",
day = "1",
doi = "10.1016/j.ajog.2014.04.009",
language = "English (US)",
volume = "211",
pages = "399.e1--399.e7",
journal = "American Journal of Obstetrics and Gynecology",
issn = "0002-9378",
publisher = "Mosby Inc.",
number = "4",

}

TY - JOUR

T1 - Removal versus retention of cerclage in preterm premature rupture of membranes

T2 - A randomized controlled trial

AU - Galyean, Anna

AU - Garite, Thomas J.

AU - Maurel, Kimberly

AU - Abril, Diana

AU - Adair, Charles D.

AU - Browne, Paul Christopher

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

PY - 2014/10/1

Y1 - 2014/10/1

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.

AB - 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.

KW - cerclage

KW - chorioamnionitis

KW - latency

KW - preterm premature rupture of membranes

UR - http://www.scopus.com/inward/record.url?scp=84907652919&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907652919&partnerID=8YFLogxK

U2 - 10.1016/j.ajog.2014.04.009

DO - 10.1016/j.ajog.2014.04.009

M3 - Article

VL - 211

SP - 399.e1-399.e7

JO - American Journal of Obstetrics and Gynecology

JF - American Journal of Obstetrics and Gynecology

SN - 0002-9378

IS - 4

ER -