17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial

Combs, C. Andrew; Garite, Thomas J.; Maurel, Kimberly; Abril, Diana; Das, Anita; Clewell, William H.; Heyborne, Kent; How, Helen; Huang, Wilson; Lewis, David F.; Lu, George; Miller, Hugh; Nageotte, Michael P.; Porreco, Richard P.; Sheikh, Asad U.; Tran, Lan; Mercer, Brian M.; Gravett, Michael G.; Clark, Reese H.; Marusiak, Barbara; Armistead, Casey; Braecsu, Ana; Gámez, M Romero; Mullen, Gloria; Lech, Jeri; Rael, Julie; Mallory, Kimberly; Mercer, Diane; Jones, N.S.; Caballero, Deysi; Guizado, Donna; Dutkiewicz, Alison; Hancock, Judy; Edgerly, Yvonne; Oosterman, Lori; Readwin, Mary; Artis, Dawn; Lopez, Tina; Waldon, Christina; Pruit, Kimberly; Swearingen, Kate

doi:10.1016/j.ajog.2015.05.009

Cited by 16 publications

(5 citation statements)

References 25 publications

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“…The presence of oligo or anhydramnion with deepest vertical amniotic pocket <2 cm related to the PPROM in mid-trimester, worsens the already poor neonatal outcome by increasing the risk of pulmonary hypoplasia [78]. In cases with "classic" PPROM, complicated by breech or transverse fetal presentation, anhydramnion is a common finding.…”

Section: Ultrasound Examinationmentioning

confidence: 99%

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Mid-trimester preterm premature rupture of membranes (PPROM): etiology, diagnosis, classification, international recommendations of treatment options and outcome

Tchirikov

Schlabritz‐Loutsevitch

Mäher

et al. 2017

Journal of Perinatal Medicine

188

153

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Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal membranes prior to 28 weeks of gestation, complicates approximately 0.4%-0.7% of all pregnancies. This condition is associated with a very high neonatal mortality rate as well as an increased risk of long-and short-term severe neonatal morbidity. The causes of the mid-trimester PPROM are multifactorial. Altered membrane morphology including marked swelling and disruption of the collagen network which is seen with PPROM can be triggered by bacterial products or/and pro-inflammatory cytokines. Activation of matrix metalloproteinases (MMP) have been implicated in the mechanism of PPROM. The propagation of bacteria is an important contributing factor not only in PPROM, but also in adverse neonatal and maternal outcomes after PPROM. Inflammatory mediators likely play a causative role in both disruption of fetal membrane integrity and activation of uterine contraction. The "classic PPROM" with oligo/anhydramnion is associated with a short latency period and worse neonatal outcome compared to similar gestational aged neonates delivered without antecedent PPROM. The "high PPROM" syndrome is defined as a defect of the chorio-amniotic membranes, which is not located over the internal cervical os. It may be associated with either a normal or reduced amount of amniotic fluid. It may explain why sensitive biochemical tests such as the Amniosure (PAMG-1) or IGFBP-1/alpha fetoprotein test can have a positive result without other signs of overt ROM such as fluid leakage with Valsalva. The membrane defect following fetoscopy also fulfils the criteria for "high PPROM" syndrome. In some cases, the rupture of only one membrane -either the chorionic or amniotic membrane, resulting in "pre-PPROM" could precede "classic PPROM" or "high PPROM". The diagnosis of PPROM is classically established by identification of nitrazine positive, fern positive watery leakage from the cervical canal observed during in specula investigation. Other more recent diagnostic tests include the vaginal swab assay for placental alpha macroglobulin-1 test or AFP and IGFBP1. In some rare cases amniocentesis and infusion of indigo carmine has been used to confirm the diagnosis of PPROM. The management of the PPROM requires balancing the potential neonatal benefits from prolongation of the pregnancy with the risk of intraamniotic infection and its consequences for the mother and infant. Close monitoring for signs of chorioamnionitis (e.g. body temperature, CTG, CRP, leucocytes, IL-6, procalcitonine, amniotic fluid examinations) is necessary to minimize the risk of neonatal and maternal complications. In addition to delayed delivery, broad spectrum antibiotics of penicillin or cephalosporin group and/or macrolide and corticosteroids have been show to improve neonatal outcome [reducing risk of chorioamnionitis (average risk ratio (RR) = 0.66), neonatal infections (RR = 0.67) and abnormal ultrasound scan of neonatal brain (RR = 0.67)]. The positive effect of continuo...

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Section: Ultrasound Examinationmentioning

confidence: 99%

“…Combs et al [45] found, that compared with placebo, weekly 17-hydroxyprogesterone caproate injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM <30 (6/7) weeks' gestation [78].…”

Section: Antibioticmentioning

confidence: 99%

Mid-trimester preterm premature rupture of membranes (PPROM): etiology, diagnosis, classification, international recommendations of treatment options and outcome

Tchirikov

Schlabritz‐Loutsevitch

Mäher

et al. 2017

Journal of Perinatal Medicine

188

153

View full text Add to dashboard Cite

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“…Of the twenty‐two included trials, 8113 participants were randomised. Nineteen trials reported data from 7125 patients evaluated the efficacy of progestogens in preventing or treating preterm birth two trials (162 patients) studied the efficacy of progestogen in preterm pre labour rupture of membranes and one trial (826 patients) investigated the efficacy of progestogen in preventing recurrent miscarriage . The route of progestogen administration was equally divided, with eleven studies using intramuscular injection and eleven by the vaginal route.…”

Section: Resultsmentioning

confidence: 99%

Inadvertent P‐hacking among trials and systematic reviews of the effect of progestogens in pregnancy? A systematic review and meta‐analysis

Prior

Hibberd

Asemota

et al. 2017

BJOG

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Background Progestogens have been evaluated in numerous trials and meta‐analyses, many of which concluded they were effective. However, two large trials PROMISE and OPPTIMUM have recently concluded that progesterone was ineffective. This raises the possibility that earlier studies and reviews had been biased by either selective publication or selective choice of outcomes, so called “P‐hacking”. Objectives To compare the findings all progestogen trials and systematic reviews with those of trials with pre‐registered primary outcomes which avoided selective outcome reporting. Search strategy Search of PubMed, the Cochrane Library and trial registries. Registration PROSPERO CRD42016035303. Selection criteria Systematic reviews of randomised trials comparing progestogen with placebo in pregnancy and the individual trials included in those reviews. The subset of trials reporting a pre‐registered primary outcome were compared with the totality of trials and reviews. Data collection and analysis For reviews all outcomes were included. For individual trials all outcomes reported in the systematic reviews were included. For the comparison group we recorded the registered primary outcome from trials that were either registered before they started, or registered during the recruitment phase and also double blind. Main results Nineteen of twenty‐nine meta‐analyses concluded that progestogens were effective. Twenty‐two trials reported their pre‐registered primary outcomes. There was no effect of progesterone on primary registered dichotomous outcome RR 1.00 (95% CI 0.94–1.07). Only one of the 22 showed a nominally statistically significant benefit. Author's conclusions When evaluated in registered double‐blind trials with analysis restricted to predefined primary outcomes, progestational agents in pregnancy are ineffective. Tweetable abstract Progestogens to prevent pregnancy loss, an example of P‐hacking.

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“…Among the methods found in the literature for preventing preterm birth, the use of tocolytics was the most found, even with many divergences among the studies regarding its recommendation. Most of the articles included in this review 2,4,[19][20][21] do not recommend its use because, despite prolonging pregnancy, it did not show beneficial effects on maternal and perinatal outcomes, besides increasing the risk of chorioamnionitis. A review of the literature 8 , published in 2015, concluded that the administration of tocolytic agents could be considered only in the short term, in the absence of intrauterine infection, for 24 to 48 hours, to allow the administration of a course of corticosteroids in pregnant women at risk of preterm delivery.…”

Section: Category 4): Use Of Tocolyticsmentioning

confidence: 99%

Preterm premature rupture of membranes: management between 28 and 34 weeks of pregnancy

2021

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Introdução: A ruptura prematura de membranas continua a ser um desafio para os profissionais devido às altas taxas de morbimortalidade materna e neonatal, relacionada principalmente às complicações decorrentes da prematuridade. Objetivo: Analisar a produção científica acerca das evidências frente a ruptura prematura de membranas em gestações acima de 28 semanas e abaixo de 34 semanas. Métodos: Revisão integrativa da literatura realizada nas bases de dados Lilacs, SciELO, Medline e Cochrane Library, entre 2014-2018, em português, inglês e espanhol, incluídos artigos originais, disponíveis completos online, com acesso livre, que abordassem a temática do estudo, utilizando os descritores “ruptura prematura de membranas ovulares”, “trabalho de parto prematuro” e “complicações na gravidez” combinados por meio dos operadores booleanos “AND” e “OR”. Resultados: Foram incluídos 14 estudos, nos quais foi possível evidenciar as principais recomendações frente a ruptura prematura de membranas fetais pré-termo, divididos em seis categorias para discussão, sendo elas: indicações para o manejo expectante e indução do parto, antibioticoterapia profilática, corticosteroides pré-natais, uso de tocolíticos, recomendações quanto ao uso de sulfato de magnésio e realização de amniocentese. Conclusão: O estudo possibilitou identificar que o manejo expectante é a conduta ideal, com monitorização constante da gestante e do feto, além da administração de antibióticos profiláticos e corticosteroides pré-natais, frente a ruptura prematura de membranas em gestações entre 28 e 34 semanas a fim de proporcionar os melhores resultados maternos e perinatais, guiando os profissionais da saúde para uma prática baseada em evidências.

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17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial

Cited by 16 publications

References 25 publications

Mid-trimester preterm premature rupture of membranes (PPROM): etiology, diagnosis, classification, international recommendations of treatment options and outcome

Mid-trimester preterm premature rupture of membranes (PPROM): etiology, diagnosis, classification, international recommendations of treatment options and outcome

Inadvertent P‐hacking among trials and systematic reviews of the effect of progestogens in pregnancy? A systematic review and meta‐analysis

Preterm premature rupture of membranes: management between 28 and 34 weeks of pregnancy

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