17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial

Winer, Norbert; Bretelle, Florence; Sénat, Marie-Victoire; Bohec, Caroline; Deruelle, Philippe; Perrotin, F.; Connan, L; Vayssière, Christophe; Langer, B.; Capelle, M.; Azimi, Shohreh; Porcher, Raphaël; Rozenberg, Patrick; Gynécologie, Groupe de Recherche en Obstétrique et

doi:10.1016/j.ajog.2014.10.1097

Cited by 43 publications

(38 citation statements)

References 62 publications

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“…Our findings for pessary, based on three studies, differed from the previous individual systematic review of one study. Overall, nine studies were included in this review that were not present in previous reviews [41][42][43]55,57,58,[60][61][62] , including the largest studies to date on progesterone and pessary. 43,58 Studies included in previous reviews that we excluded are listed in the Supporting information (Table S5).…”

Section: Interpretation In Light Of Other Evidencementioning

confidence: 99%

“…A control group of usual care or placebo was compared with progesterone (either type) in 17 studies, [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] with cerclage in 12 studies [44][45][46][47][48][49][50][51][52][53][54][55] and with pessary in three studies. [56][57][58] In addition, one study compared 17-OHPC with cerclage 59 and three studies compared natural progesterone with 17-OHPC [60][61][62] (Table 1, and see Supporting information, Figure S2).…”

Section: Study Characteristicsmentioning

confidence: 99%

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Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

Jarde

Lutsiv

Park

et al. 2017

BJOG

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Background Preterm birth (PTB) is the leading cause of infant death, but it is unclear which intervention is best to prevent it.Objectives To compare progesterone, cerclage and pessary, determine their relative effects and rank them.Search strategy We searched Medline, EMBASE, CINAHL, Cochrane CENTRAL and Web of Science (to April 2016), without restrictions, and screened references of previous reviews.Selection criteria We included randomised trials of progesterone, cerclage or pessary for preventing PTB in women with singleton pregnancies at risk as defined by each study.Data collection and analysis We extracted data by duplicate using a piloted form and performed Bayesian random-effects network meta-analyses and pairwise meta-analyses. We rated evidence quality using GRADE, ranked interventions using SUCRA and calculated numbers needed to treat (NNT).Main results We included 36 trials (9425 women; 25 low risk of bias trials). Progesterone ranked first or second for most outcomes, reducing PTB < 34 weeks [odds ratio (OR) 0.44; 95% credible interval (CrI) 0.22-0.79; NNT 9; low quality], <37 weeks (OR 0.58; 95% CrI 0.41-0.79; NNT 9; moderate quality), and neonatal death (OR 0.50; 95% CrI 0.28-0.85; NNT 35; high quality), compared with control, in women overall at risk. We found similar results in the subgroup with previous PTB, but only a reduction of PTB < 34 weeks in women with a short cervix. Pessary showed inconsistent benefit and cerclage did not reduce PTB < 37 or <34 weeks.Conclusions Progesterone was the best intervention for preventing PTB in singleton pregnancies at risk, reducing PTB < 34 weeks, <37 weeks, neonatal demise and other sequelae.Keywords Cervical cerclage, cervical pessary, network metaanalysis, preterm birth, progesterone, systematic review.Tweetable abstract Progesterone was better than cerclage and pessary to prevent preterm birth, neonatal death and more in network meta-analysis.Please cite this paper as: Jarde A, Lutsiv O, Park CK, Beyene J, Dodd JM, Barrett J, Shah PS, Cook JL, Saito S, Biringer AB, Sabatino L, Giglia L, Han Z, Staub K, Mundle W, Chamberlain J, McDonald SD. Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta-analysis.

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Section: Interpretation In Light Of Other Evidencementioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

Jarde

Lutsiv

Park

et al. 2017

BJOG

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“…The primary outcome, time from randomization to delivery, did not differ between study arms. In addition, the rate of preterm delivery before 37 weeks was similar in the 17-OHPC arm and the control group (45 vs 44%, p>0.99) 45 . The trial had several limitations including the timing of the initiation of 17-OHPC at a median gestational age of 24 weeks and 6 days.…”

Section: -Ohpc In Women With a Short Cervical Lengthmentioning

confidence: 72%

“…Winer et al randomized women with a singleton pregnancy, cervical length less than 25 mm, and a history of preterm delivery or cervical surgery to treatment with 17-OHPC 500 mg weekly or no treatment 45 . The primary outcome, time from randomization to delivery, did not differ between study arms.…”

Section: -Ohpc In Women With a Short Cervical Lengthmentioning

confidence: 99%

“…While two observational studies noted similar rates of preterm delivery in women who started 17-OHPC early (16–20.9 weeks) or later (21–26.9 weeks) in pregnancy, a later start contradicts the suggested prophylactic mechanism of action of the drug 46, 47 . In addition, the authors highlighted the possible confounding effect of cerclage use prior to randomization, which occurred in 45% of the 17-OHPC group and 38% of the control group 45 . A similar strategy, albeit with a higher dose of 17-OHPC 500 mg intramuscular injections twice weekly, was evaluated in twin gestations with a short cervical length (<25 mm) 33 .…”

Section: -Ohpc In Women With a Short Cervical Lengthmentioning

confidence: 99%

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What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth

Caritis

Feghali

Grobman

et al. 2016

Seminars in Perinatology

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Despite major advances in neonatal care, the burden of preterm birth remains high. This is not unexpected since strategies to identify and treat risk factors in early pregnancy have not been very effective in reducing the preterm birth rate. Initial studies suggested a potential benefit for 17- alpha-hydroxyprogesterone caproate (17-OHPC) in decreasing the risk of recurrent preterm birth women with a singleton gestation. However, the use of 17-OHPC has not conferred benefit for other categories of women at high-risk for preterm delivery (twins, triplets, short cervical length). The increasing body of evidence suggests that preterm birth is a complex condition with variable mechanisms of disease and significant individual heterogeneity. This review will examine the plausibility of 17-OHPC in preventing preterm birth and the investigation of its clinical efficacy. We will also highlight factors to explain variations in clinical trial outcomes and outline the trajectory needed for future investigations.

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A systematic review and meta‐analysis of randomized controlled trials comparing 17‐alpha‐hydroxyprogesterone caproate versus placebo for the prevention of recurrent preterm birth

Fernández-Macías

Martinez‐Portilla

Cerrillos

et al. 2019

Intl J Gynecology & Obste

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Background: Preterm birth causes an increased risk for perinatal morbidity and mortality.Objective: To determine whether mid-trimester 17-alpha-hydroxyprogesterone caproate (17-OHPC) reduces the risk of recurrent preterm birth and adverse perinatal outcomes.Search strategy: Systematic search to identify relevant studies published in different languages, registered after 2000, using appropriate MeSH terms.Selection criteria: Inclusion criteria were women between 16 and 26 +6 weeks of pregnancy with history of preterm delivery in any pregnancy randomized to either 17-OHPC or placebo/no treatment. Data collection and analysis:The number of preterm births and adverse outcomes in the 17-OHPC and placebo arms over the total number of patients in each randomized group were used to calculate the risk ratio (RR) by random-effects models using the Mantel-Haenszel method. Between-study heterogeneity was assessed using tau 2 , χ 2 (Cochrane Q), and I 2 statistics.Main results: Four studies were included. There was a 29% (RR 0.71; 95% CI, 0.53-0.96; P=0.001), 26% (RR 0.74; 95% CI, 0.58-0.96; P=0.021), and 40% (RR 0.60; 95% CI, 0.42-0.85; P=0.004) reduction in recurrent preterm birth at <37, <35, and <32 weeks, respectively, in the 17-OHPC group compared with placebo. The reduction in neonatal death was 68% (RR 0.32; 95% CI, 0.15-0.66; P=0.002).Conclusions: 17-OHPC could reduce the risk of recurrent preterm birth at <37, <35, and <28 weeks and neonatal death. PROSPERO: CDR42017082190 K E Y W O R D S 17-alpha-hydroxyprogesterone caproate; Intramuscular progesterone; Meta-analysis; Preterm birth; Recurrent preterm birth; Systematic review | 157 Fernandez-Macias eT aL. −− 100.0% −− −− 69.0% 31.0% 35.3% 13.0% 20.8% 31.0% Weight | 163 Fernandez-Macias eT aL.

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17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial

Cited by 43 publications

References 62 publications

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth

A systematic review and meta‐analysis of randomized controlled trials comparing 17‐alpha‐hydroxyprogesterone caproate versus placebo for the prevention of recurrent preterm birth

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