{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T05:51:24Z","timestamp":1780465884702,"version":"3.54.1"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,2,6]],"date-time":"2017-02-06T00:00:00Z","timestamp":1486339200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ultrasound in Obstet &amp; Gyne"],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Randomized controlled trials (RCTs) have recently compared intramuscular 17\u03b1\u2010hydroxyprogesterone caproate (17\u2010OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta\u2010analysis was to evaluate the efficacy of vaginal progesterone compared with 17\u2010OHPC in prevention of SPTB in singleton gestations with prior SPTB.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Searches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17\u2010OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB &lt; 34 weeks. Secondary outcomes were SPTB &lt; 37 weeks, &lt; 32 weeks, &lt; 28 weeks and &lt; 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measures were reported as relative risk (RR) with 95% CI. Risk of bias for each included study was assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Three RCTs (680 women) were included. The mean gestational age at randomization was about 16 weeks. Women were given progesterone until 36 weeks or delivery. Regarding vaginal progesterone, one study used 90 mg gel daily, one used 100 mg suppository daily and one used 200 mg suppository daily. All included RCTs used 250 mg intramuscular 17\u2010OHPC weekly in the comparison group. Women who received vaginal progesterone had significantly lower rates of SPTB &lt; 34 weeks (17.5% <jats:italic>vs<\/jats:italic> 25.0%; RR, 0.71 (95% CI, 0.53\u20130.95); low quality of evidence) and &lt; 32 weeks (8.9% <jats:italic>vs<\/jats:italic> 14.5%; RR, 0.62 (95% CI, 0.40\u20130.94); low quality of evidence) compared with women who received 17\u2010OHPC. There were no significant differences in the rates of SPTB &lt; 37 weeks, &lt; 28 weeks and &lt; 24 weeks. The rate of women who reported adverse drug reactions was significantly lower in the vaginal progesterone group compared with the 17\u2010OHPC group (7.1% <jats:italic>vs<\/jats:italic> 13.2%; RR, 0.53 (95% CI, 0.31\u20130.91); very low quality of evidence). Regarding neonatal outcomes, vaginal progesterone was associated with a lower rate of neonatal intensive care unit admission compared with 17\u2010OHPC (18.7% <jats:italic>vs<\/jats:italic> 23.5%; RR, 0.63 (95% CI, 0.47\u20130.83); low quality of evidence). For the comparison of 17\u2010OHPC <jats:italic>vs<\/jats:italic> vaginal progesterone, the quality of evidence was downgraded for all outcomes by at least one degree due to imprecision (the optimal information size was not reached) and by at least one degree due to indirectness (different interventions).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Daily vaginal progesterone (either suppository or gel) started at about 16 weeks' gestation is a reasonable, if not better, alternative to weekly 17\u2010OHPC injection for prevention of SPTB in women with singleton gestations and prior SPTB. However, the quality level of the summary estimates was low or very low as assessed by GRADE, indicating that the true effect may be, or is likely to be, substantially different from the estimate of the effect. Copyright \u00a9 2016 ISUOG. Published by John Wiley &amp; Sons Ltd.<\/jats:p><\/jats:sec><jats:sec><jats:title>Comparaci\u00f3n entre la progesterona vaginal y el 17\u03b1\u2010hidroxiprogesterona caproato intramuscular para la prevenci\u00f3n del parto pret\u00e9rmino espont\u00e1neo recurrente en embarazos con feto \u00fanico: revisi\u00f3n sistem\u00e1tica y metaan\u00e1lisis de ensayos controlados aleatorios<\/jats:title><jats:p><jats:bold>RESUMEN<\/jats:bold><\/jats:p><\/jats:sec><jats:sec><jats:title>Objetivo<\/jats:title><jats:p>Recientemente se han realizado varios ensayos controlados aleatorios (ECA) que comparaban el caproato de 17\u03b1\u2010hidroxiprogesterona (17\u2010OHPC, por sus siglas en ingl\u00e9s) por v\u00eda intramuscular con la progesterona por v\u00eda vaginal para la reducci\u00f3n del riesgo de parto pret\u00e9rmino espont\u00e1neo (PPTE) en embarazos con feto \u00fanico de gestantes con historial de PPTE. El objetivo de esta revisi\u00f3n sistem\u00e1tica y metaan\u00e1lisis fue evaluar la eficacia de la progesterona vaginal en comparaci\u00f3n con la 17\u2010OHPC en la prevenci\u00f3n de embarazos con feto \u00fanico de gestantes con historial de PPTE.<\/jats:p><\/jats:sec><jats:sec><jats:title>M\u00e9todos<\/jats:title><jats:p>Se realizaron b\u00fasquedas en bases de datos electr\u00f3nicas para identificar todos los ECA con embarazos de feto \u00fanico asintom\u00e1ticos con historial de PPTE antes de ser asignados al azar a un tratamiento profil\u00e1ctico, ya fuera con progesterona vaginal (grupo de intervenci\u00f3n) o con 17\u2010OHPC intramuscular (grupo de control). No se aplicaron restricciones respecto al idioma o la ubicaci\u00f3n geogr\u00e1fica. El resultado primario fue PPTE &lt; 34 semanas. Los resultados secundarios fueron PPTE &lt;37 semanas, &lt; 32 semanas, &lt; 28 semanas y &lt; 24 semanas, la reacci\u00f3n materna adversa al f\u00e1rmaco y los resultados neonatales. Las medidas del resumen se reportaron como riesgo relativo (RR) con IC del 95%. Para cada estudio incluido se evalu\u00f3 el riesgo de sesgo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Resultados<\/jats:title><jats:p>Se incluyeron tres ECA (680 mujeres). La media de la edad gestacional en el momento de la aleatorizaci\u00f3n fue de 16 semanas. A las mujeres se les administr\u00f3 progesterona hasta la semana 36 o hasta el parto. Con respecto a la progesterona vaginal, un estudio utiliz\u00f3 gel de 90 mg diariamente, otro utiliz\u00f3 un supositorio diario de 100 mg y el otro utiliz\u00f3 un supositorio diario de 200 mg. Todos los ECA incluidos en el grupo de comparaci\u00f3n utilizaron 250 mg semanales de 17\u2010OHPC por v\u00eda intramuscular. Las mujeres que recibieron progesterona vaginal tuvieron tasas significativamente m\u00e1s bajas de PPTE &lt; 34 semanas (17,5% vs. 25,0%; RR 0,71 (IC 95%, 0,53\u20130,95); calidad de la evidencia baja) y &lt; 32 semanas (8,9% vs. 14,5%; RR 0,62 (IC 95%, 0,40\u20130,94); calidad de evidencia baja), en comparaci\u00f3n con las mujeres que recibieron 17\u2010OHPC. No hubo diferencias significativas en las tasas de PPTE &lt; 37 semanas, &lt; 28 semanas y &lt; 24 semanas. La tasa de mujeres que reportaron reacciones adversas a los medicamentos fue significativamente menor en el grupo de progesterona vaginal en comparaci\u00f3n con el grupo de 17\u2010OHPC (7,1% vs. 13,2%; RR 0,53 (IC 95%, 0,31\u20130,91); calidad de la evidencia muy baja). En cuanto a los resultados neonatales, la progesterona vaginal se asoci\u00f3 a una menor tasa de admisiones en la unidad neonatal de cuidados intensivos en comparaci\u00f3n con la 17\u2010OHPC (18,7% vs. 23,5%; RR 0,63 (IC 95%, 0,47\u20130,83); calidad de evidencia baja). Para la comparaci\u00f3n del 17\u2010OHPC con la progesterona vaginal se rebaj\u00f3 la calidad de las pruebas para todos los resultados en al menos un grado debido a imprecisiones (no se alcanz\u00f3 el tama\u00f1o \u00f3ptimo de la informaci\u00f3n) y en al menos un grado debido al car\u00e1cter indirecto de los estudios (diferentes intervenciones).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusiones<\/jats:title><jats:p>La progesterona vaginal administrada diariamente (ya fuera como supositorio o como gel) desde la semana 16 de gestaci\u00f3n es una alternativa razonable, si no mejor, a una inyecci\u00f3n semanal de 17\u2010OHPC para la prevenci\u00f3n de PPTE en mujeres con embarazos de feto \u00fanico e historial de PPTE. Sin embargo, el nivel de calidad de las estimaciones del resumen fue bajo o muy bajo seg\u00fan lo evaluado por GRADE, lo que indica que el verdadero efecto puede ser, o es probable que sea, sustancialmente diferente de la estimaci\u00f3n del efecto.<\/jats:p><\/jats:sec><jats:sec><jats:title>\u5355\u80ce\u598a\u5a20\u65f6\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u4e0e\u808c\u8089\u6ce8\u5c0417\u03b1\u2010\u5df2\u9178\u7f9f\u5b55\u916e\u9884\u9632\u590d\u53d1\u6027\u81ea\u53d1\u6027\u65e9\u4ea7:\u7cfb\u7edf\u56de\u987e\u548c\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c\u7684meta\u5206\u6790<\/jats:title><\/jats:sec><jats:sec><jats:title>\u76ee\u7684<\/jats:title><jats:p>\u6700\u8fd1\u6709\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c(randomized controlled trials,<jats:styled-content style=\"fixed-case\">RCTs<\/jats:styled-content>)\u5bf9\u6bd4\u4e86\u6709\u81ea\u53d1\u6027\u65e9\u4ea7(spontaneous preterm birth,<jats:styled-content style=\"fixed-case\">SPTB<\/jats:styled-content>)\u65e2\u5f80\u53f2\u7684\u5355\u80ce\u598a\u5a20\u4e2d\u808c\u8089\u6ce8\u5c0417\u03b1\u2010\u5df2\u9178\u7f9f\u5b55\u916e(intramuscular 17\u03b1\u2010hydroxyprogesterone caproate,17\u2010<jats:styled-content style=\"fixed-case\">OHPC<\/jats:styled-content>)<jats:styled-content style=\"fixed-case\">\u4e0e\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u964d\u4f4eSPTB\u7684\u98ce\u9669<\/jats:styled-content>\u3002<jats:styled-content style=\"fixed-case\">\u672c\u7bc7\u7cfb\u7edf\u56de\u987e\u548cmeta\u5206\u6790\u7684\u76ee\u7684\u662f\u8bc4\u4f30\u5728\u6709SPTB\u65e2\u5f80\u53f2\u7684\u5355\u80ce\u598a\u5a20\u4e2d\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u5bf9\u6bd417\u2010OHPC\u9884\u9632SPTB\u7684\u7597\u6548<\/jats:styled-content>\u3002<\/jats:p><\/jats:sec><jats:sec><jats:title>\u65b9\u6cd5<\/jats:title><jats:p>\u68c0\u7d22\u7535\u5b50\u6570\u636e\u5e93,<jats:styled-content style=\"fixed-case\">\u67e5\u627e\u5173\u4e8e\u6709SPTB\u65e2\u5f80\u53f2\u7684\u65e0\u75c7\u72b6\u5355\u80ce\u598a\u5a20\u7684\u6240\u6709RCTs<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\">RCTs\u4e2d\u5c06\u60a3\u8005\u968f\u673a\u5206\u4e3a\u63a5\u53d7\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f<\/jats:styled-content>(\u5e72\u9884\u7ec4)\u6216\u808c\u8089\u6ce8\u5c0417\u2010<jats:styled-content style=\"fixed-case\">OHPC<\/jats:styled-content>(\u5bf9\u7167\u7ec4)\u3002\u5bf9\u8bed\u8a00\u6216\u5730\u7406\u4f4d\u7f6e\u65e0\u9650\u5236\u3002<jats:styled-content style=\"fixed-case\">\u4e3b\u8981\u7ed3\u5c40\u4e3a\u5b5534\u5468\u524d\u53d1\u751fSPTB<\/jats:styled-content>\u3002\u6b21\u8981\u7ed3\u5c40\u4e3a\u5b5537\u5468\u524d\u3001\u5b5532\u5468\u524d\u3001<jats:styled-content style=\"fixed-case\">\u5b5528\u5468\u524d\u548c\u5b5524\u5468\u524d\u53d1\u751fSPTB<\/jats:styled-content>,\u6bcd\u4eb2\u4e0d\u826f\u836f\u7269\u53cd\u5e94\u4ee5\u53ca\u65b0\u751f\u513f\u7ed3\u5c40\u3002\u7efc\u5408\u68c0\u6d4b\u7ed3\u679c\u4ee5\u76f8\u5bf9\u5371\u9669\u5ea6(relative risk,<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>)\u548c95%<jats:styled-content style=\"fixed-case\">CI\u8868\u793a<\/jats:styled-content>\u3002\u5bf9\u6bcf\u9879\u7eb3\u5165\u7814\u7a76\u7684\u504f\u501a\u98ce\u9669\u8fdb\u884c\u8bc4\u4f30\u3002<\/jats:p><\/jats:sec><jats:sec><jats:title>\u7ed3\u679c<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">\u7eb3\u51653\u9879RCTs<\/jats:styled-content>(680\u4f8b\u5b55\u5987)\u3002\u968f\u673a\u5206\u7ec4\u65f6\u5e73\u5747\u5b55\u5468\u7ea6\u4e3a16\u5468\u3002\u7ed9\u4e88\u5b55\u5987\u9ec4\u4f53\u916e,\u76f4\u81f3\u5b5536\u5468\u6216\u5206\u5a29\u3002\u5728\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u7ec4\u4e2d,\u4e00\u9879\u7814\u7a76\u91c7\u7528\u6bcf\u65e590 mg\u51dd\u80f6,\u4e00\u9879\u91c7\u7528\u6bcf\u65e5100 mg\u6813\u5242,\u53e6\u5916\u4e00\u9879\u7814\u7a76\u91c7\u7528\u6bcf\u65e5200 mg\u6813\u5242\u3002\u5bf9\u7167\u7ec4\u4e2d,<jats:styled-content style=\"fixed-case\">\u6240\u6709\u7eb3\u5165\u7684RCTs\u5747\u91c7\u7528\u6bcf\u5468250<\/jats:styled-content> mg 17\u2010<jats:styled-content style=\"fixed-case\">OHPC\u808c\u8089\u6ce8\u5c04<\/jats:styled-content>\u3002\u4e0e17\u2010<jats:styled-content style=\"fixed-case\">OHPC\u7ec4\u5b55\u5987\u76f8\u6bd4<\/jats:styled-content>,\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u7ec4\u5b55\u5987\u5b5534\u5468\u524d [17.5%\u548c25.0%;<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>,0.71(95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>,0.53 ~ 0.95);\u4f4e\u8d28\u91cf\u8bc1\u636e]\u548c\u5b5532\u5468\u524d[8.9%\u548c14.5%;<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>,0.62(95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>,0.40 ~ 0.94);\u4f4e\u8d28\u91cf\u8bc1\u636e]<jats:styled-content style=\"fixed-case\">SPTB\u7684\u53d1\u751f\u7387\u660e\u663e\u8f83\u4f4e<\/jats:styled-content>\u3002\u5b5537\u5468\u524d\u3001<jats:styled-content style=\"fixed-case\">\u5b5528\u5468\u524d\u548c\u5b5524\u5468\u524dSPTB\u7684\u53d1\u751f\u7387\u65e0\u660e\u663e\u5dee\u5f02<\/jats:styled-content>\u3002\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u7ec4\u4e0e17\u2010<jats:styled-content style=\"fixed-case\">OHPC\u7ec4\u6bd4\u8f83<\/jats:styled-content>,\u5b55\u5987\u4e0d\u826f\u836f\u7269\u53cd\u5e94\u7684\u53d1\u751f\u7387\u660e\u663e\u8f83\u4f4e[7.1%\u548c13.2%;<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>,0.53(95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>,0.31 ~ 0.91);\u6781\u4f4e\u8d28\u91cf\u8bc1\u636e]\u3002\u5728\u65b0\u751f\u513f\u7ed3\u5c40\u65b9\u9762,\u4e0e17\u2010<jats:styled-content style=\"fixed-case\">OHPC\u7ec4\u6bd4\u8f83<\/jats:styled-content>,\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u7ec4\u65b0\u751f\u513f\u91cd\u75c7\u76d1\u62a4\u75c5\u623f\u4f4f\u9662\u7387\u8f83\u4f4e[18.7%\u548c23.5%;<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>,0.63(95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>,0.47 ~ 0.83);\u4f4e\u8d28\u91cf\u8bc1\u636e]\u3002\u5bf917\u2010<jats:styled-content style=\"fixed-case\">OHPC\u548c\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f\u8fdb\u884c\u6bd4\u8f83<\/jats:styled-content>,\u6240\u6709\u7ed3\u5c40\u7684\u8bc1\u636e\u8d28\u91cf\u7531\u4e8e\u4e0d\u7cbe\u786e\u964d\u4f4e\u81f3\u5c11\u4e00\u7ea7(\u672a\u8fbe\u5230\u6700\u4f73\u4fe1\u606f\u91cf),\u7531\u4e8e\u95f4\u63a5\u6027\u81f3\u5c11\u964d\u4f4e\u4e00\u7ea7(\u4e0d\u540c\u5e72\u9884\u63aa\u65bd)\u3002<\/jats:p><\/jats:sec><jats:sec><jats:title>\u7ed3\u8bba<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">\u4e3a\u4e86\u9884\u9632\u6709SPTB\u65e2\u5f80\u53f2\u7684\u5355\u80ce\u598a\u5a20\u5b55\u5987\u53d1\u751fSPTB<\/jats:styled-content>,\u5728\u7ea6\u5b5516\u5468\u65f6\u5f00\u59cb\u6bcf\u65e5\u9ec4\u4f53\u916e\u9634\u9053\u7ed9\u836f(\u6813\u5242\u6216\u51dd\u80f6)\u662f\u6bcf\u5468\u6ce8\u5c0417\u2010<jats:styled-content style=\"fixed-case\">OHPC\u7684\u4e00\u9879\u5408\u7406\u7684<\/jats:styled-content>,\u5373\u4f7f\u4e0d\u662f\u66f4\u597d\u7684\u66ff\u4ee3\u65b9\u6848\u3002\u7136\u800c,<jats:styled-content style=\"fixed-case\">\u6839\u636eGRADE<\/jats:styled-content>,\u7efc\u5408\u8bc4\u4f30\u7684\u8d28\u91cf\u6c34\u5e73\u8f83\u4f4e\u6216\u6781\u4f4e,\u8868\u660e\u771f\u5b9e\u7684\u6548\u679c\u53ef\u80fd\u6216\u5f88\u53ef\u80fd\u4e0e\u4f30\u8ba1\u7684\u6548\u679c\u5927\u4e0d\u76f8\u540c\u3002<\/jats:p><\/jats:sec>","DOI":"10.1002\/uog.17245","type":"journal-article","created":{"date-parts":[[2016,8,22]],"date-time":"2016-08-22T09:24:25Z","timestamp":1471857865000},"page":"315-321","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":65,"title":["Vaginal progesterone <i>vs<\/i> intramuscular 17\u03b1\u2010hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta\u2010analysis of randomized controlled trials"],"prefix":"10.1002","volume":"49","author":[{"given":"G.","family":"Saccone","sequence":"first","affiliation":[{"name":"Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine University of Naples Federico II  Naples Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Khalifeh","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology Sidney Kimmel Medical College of Thomas Jefferson University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Elimian","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology, New York Medical College Westchester Medical Center  Valhalla NY 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