Outcomes With Cerclage Alone Compared With Cerclage Plus 17α-Hydroxyprogesterone Caproate

Stetson, Bethany; Hibbard, Judith U.; Wilkins, Isabelle; Leftwich, Heidi

doi:10.1097/aog.0000000000001681

Cited by 18 publications

(22 citation statements)

References 11 publications

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“…In addition, health insurance companies continually refused to issue prior authorizations to commence 17‐OHPC as adjunctive therapy in women with a history‐indicated cerclage, asserting that it remains investigational in this setting and is not supported by available data . One recent retrospective cohort study reported that combination therapy (cerclage+17‐OHPC) was more effective than cerclage alone for preventing spontaneous preterm birth at less than 24 weeks, but not at less than 28 or 37 weeks of gestation . However, the small number of spontaneous preterm births <24 weeks in this study precludes a clear conclusion about the efficacy of combined therapy.…”

Section: Introductioncontrasting

confidence: 56%

“…Four of the studies were retrospective cohort studies and one was a randomized trial . Four of the studies were carried out in the USA and one was done in Israel . Two of the studies were published in 2018, in 2016, in 2014 and one in 1985 .…”

Section: Resultsmentioning

confidence: 99%

“…Four of the studies were carried out in the USA and one was done in Israel . Two of the studies were published in 2018, in 2016, in 2014 and one in 1985 . All the studies included women with singleton pregnancies and a history of prior spontaneous preterm birth.…”

Section: Resultsmentioning

confidence: 99%

“…These included a history of multiple gestations and of therapeutic cerclage (history or ultrasound‐indicated cerclage). Other exclusion criteria related to specific studies include delivery at an outside institution, abdominal cerclage, multiple cerclages in the same women, concomitant use of vaginal progesterone, stillbirth, lethal fetal anomalies, women who received less than four 17‐OHPC injections, incomplete delivery information, patients lost to follow up, diabetes mellitus, chronic renal disease and chronic hypertension …”

Section: Resultsmentioning

confidence: 99%

“…However, despite the effectiveness of history‐indicated cerclage in reducing the risk of spontaneous preterm birth, about one‐third of women that receive prophylactic cerclage still deliver preterm . This makes adjunctive therapies appealing options in maximizing the effectiveness of prophylactic cervical cerclage in prolonging pregnancy …”

Section: Introductionmentioning

confidence: 99%

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Adjuvant 17‐hydroxyprogesterone caproate in women with history‐indicated cerclage: A systematic review and meta‐analysis

Eke

Sheffield

Graham

2018

Acta Obstet Gynecol Scand

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Introduction The purpose of this study was to evaluate whether there are additional benefits of 17‐hydroxyprogesterone caproate (17‐OHPC) supplementation in preventing recurrent spontaneous preterm birth in women with a prophylactic cerclage. Material and methods Electronic databases (MEDLINE, Scopus, ClinicalTrials.gov, PROSPERO, EMBASE, Scielo and the Cochrane Central Register of Controlled Trials) were searched for studies published before June 2018. Keywords included “preterm birth”, “prophylactic cerclage”, “history‐indicated cerclage”, “pregnancy” and “17‐hydroxyprogesterone caproate”. Studies comparing history‐indicated cerclage alone with cerclage+17‐OHPC were included. The primary outcome measure was preterm birth at <24 weeks of gestation. Secondary outcome measures include preterm birth at <28 weeks, <32 weeks and <37 weeks of gestation, respiratory distress syndrome, necrotizing enterocolitis, fetal birthweight, neonatal intensive care unit stay, mean gestational age at delivery, fetal/neonatal death, neurological morbidity (intraventricular hemorrhage plus periventricular leukomalacia), neonatal sepsis and a composite of severe neonatal morbidity. Severe neonatal morbidity was defined as a composite measure of periventricular leukomalacia, intraventricular hemorrhage (grades III and IV), necrotizing enterocolitis or respiratory distress syndrome. Meta‐analysis was performed using the random‐effects model of DerSimonian and Laird. Risk of bias and quality assessment were performed using the ROBINS‐I and GRADE tools, respectively. PROSPERO Registration Number: CRD42018094559. Results Five studies met the inclusion criteria and were included in the final analysis. Of the 546 women, 357 (75%) received history‐indicated cerclage alone and 189 (35%) received adjuvant 17‐OHPC. The composite endpoint, severe neonatal morbidity, was present in 84 of 1515 neonates. Though there was a trend toward a reduced risk of preterm birth, the summary estimate of effect was not statistically significant when comparing cerclage alone with cerclage+17‐OHPC at <24 weeks (relative risk [RR] .86, 95% confidence interval [CI] .45‐1.65). Similarly, we found no differences in preterm birth at <37 weeks (RR .90, 95% CI .70‐1.17) and <28 weeks (RR .85, 95% CI .54‐1.32) when comparing cerclage alone with cerclage+17‐OHPC. There were no differences in fetal birthweight, respiratory distress syndrome or necrotizing enterocolitis comparing cerclage alone with cerclage+17‐OHPC. Conclusions Intramuscular 17‐OHPC in combination with prophylactic cerclage in women with prior preterm birth had no synergistic effect in reducing spontaneous recurrent preterm birth or improving perinatal outcomes.

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Section: Introductioncontrasting

confidence: 56%