RETRACTED ARTICLE: Vaginal progesterone for prevention of
              preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a
              randomized clinical trial of efficacy and safety

El-refaie, Waleed; Abdelhafez, Mohamed; Badawy, Ahmed

doi:10.1007/s00404-015-3767-1

Cited by 62 publications

(99 citation statements)

References 27 publications

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“…16 Conversely, and at variance with present findings, other clinical trials concluded that vaginal progesterone, administration in asymptomatic twin pregnancies with a sonographic short cervix (20-25 mm) at 20-24 weeks of gestation was found effective and safe treatment for reducing the incidence of preterm labor. 17,18 In view of arguable issues concerning the efficacy of the use of progesterone or cerclage alone in preventing preterm birth in twin gestations, present study by far, may be one of only few if any, in the accessible literature which evaluated a dual approach of both progesterone and cervical cerclage in prevention of preterm labour in twin gestation. In current study, combined progesterone as well as cerclage was found efficacious in reducing preterm labour prior to 34 weeks and 34-37 weeks of gestation with a statistically significant difference when compared to either progesterone or cerclage groups while there was no significant difference between the two latter groups.…”

Section: Discussionmentioning

confidence: 99%

Effect of vaginal progesterone in combination with cervical cerclage on improved gestational age and perinatal outcome in twin pregnancy: A prospective randomized study

AbdElaal

Sanad

Shaheen

et al. 2017

Int J Reprod Contracept Obstet Gynecol

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Background: Prematurity is the second leading cause of death in the first month of life. Objective of present study was to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.Methods: A sample size of seventy-five patients has been calculated out of those recruited from outpatient clinic at menoufia university hospital. All fulfilled eligibility criteria of having a twin pregnancy with a history of spontaneous preterm labour, or with a sonographic short cervical length <25mm in mid trimester. The participants were randomly assigned to three groups. Group 1 (N-25): received vaginal progesterone supplementation of 200 mg from 20 weeks until 34 weeks of gestation. Group2 (N-25): were remedied with cervical cerclage of Mc Donald type at 14-16 weeks of gestation Group 3 (N-25): received both vaginal progesterone as well as cervical cerclage. The primary outcome measure was spontaneous delivery between 34-37 weeks of gestation. Secondary outcomes were delivery prior 34 weeks of gestation as well as some parameters of neonatal morbidity and mortality.Results: There was a statistically significant higher gestational age in combination group when compared to progesterone group or cerclage group (P<0.001). Comparison between progesterone and cerclage groups did not reach statistical significance(P=-0.85). Both progesterone and cerclage groups demonstrated significantly lower birth weights, lower Apgar scores and a higher NICU admission rate than in combination group(P<0.001), while such significant difference did not exist between progesterone and cerclage groups.Conclusions: Combination of vaginal progesterone and cervical cerclage can improve gestational age at delivery as well as some parameters of perinatal morbidity and mortality in twin pregnancy.

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Section: Discussionmentioning

confidence: 99%

Effect of vaginal progesterone in combination with cervical cerclage on improved gestational age and perinatal outcome in twin pregnancy: A prospective randomized study

AbdElaal

Sanad

Shaheen

et al. 2017

Int J Reprod Contracept Obstet Gynecol

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“…We would like to thank Dr. Aeli Ryu, Dr. Tae-Hee Kim and Dr. Hae-Hyeog Lee for their interest in our study [1] and their valuable comments [2].…”

Section: Dear Editormentioning

confidence: 97%

Comment to the letter: The effects of progesterone in women undergoing preterm labor

El-refaie

Abdelhafez

Badawy

2015

Arch Gynecol Obstet

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and their valuable comments [2]. As noted by our colleagues, the role of progesterone in prevention of preterm labor has been investigated for decades. Administration of 17-hydroxyprogesterone caproate during pregnancy has been approved by the Food and Drug Administration (FDA) to decrease the risk of recurrent preterm labor in women with a history of at least one previous spontaneous preterm labor [3]. Moreover, different progesterone forms (vaginal, intramuscular and oral) have been shown to be effective in reducing preterm labor [4]. However, there is no sufficient evidence to use progesterone for treating threatened or established preterm labor [5].We are in agreement with our colleagues in that vaginal progesterone administration is very convenient and more beneficial with lower incidence of side effects than progesterone administration by other routes. Many randomized clinical trials on singleton pregnancies concluded that vaginal progesterone administration reduces the rate of preterm labor in high risk patients as those with short cervix [6] or those with history of prior preterm labor [7].We aimed in our study to evaluate the efficacy of vaginal progesterone administration from the midtrimester for prevention (not treatment) of preterm labor in asymptomatic twin pregnancies at risk for preterm labor due to short cervical length. We found nearly a 33 % relative reduction in the rate of preterm labor before 34 weeks of gestation with subsequent improvement in the neonatal outcome.Based on the results of our study and the results of others' studies, we agree with our colleagues in that vaginal progesterone is safe and effective for prevention (not treatment) of preterm labor with subsequent reduction of the prematurity-related neonatal morbidities and mortality in asymptomatic singleton and twin pregnancies with sonographic short cervix. However, further studies are needed to confirm the results of our study and also, the efficacy of vaginal progesterone administration in women with threatened or established preterm labor remains to be further investigated. Once again, we thank our colleagues for their useful comments. Compliance with ethical standardsConflict of interest We declare that we have no conflict of interest. References 1. El-refaie W, Abdelhafez MS, Badawy A (2015) Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety. Arch Gynecol Obstet.

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“…Estos estudios abren la puerta al uso de cerclaje profiláctico en pacientes con embarazo gemelar bien seleccionadas, haciendo manifiesta la necesidad de realizar estudios clínicos las 34 semanas del 33% RR 0,67 [IC 95% 0,49-0,90], así como también de parto prematuro antes de las 32 semanas EG, RN menores de 1500 y 2500 grs, síndrome de distress respiratorio, mortalidad neonatal precoz y necesidad de ventilación mecánica en los recién nacidos del grupo expuesto a progesterona (22). Lo relevante de este trabajo es que es el primer ECR que ha demostrado que progesterona vaginal en dosis de 400 mg diarios, podría reducir el parto prematuro en embarazos gemelares con LC ≤ 25 mm.…”

Section: Progesteronaunclassified

“…En 3 de estos se utilizó 17-OH Caproato de progesterona intramuscular y en los otros 9, progesterona micronizada vaginal en dosis de 200 a 400 mg diarios. Solo en uno de estos estudio se consideró la longitud cervical como criterio de inclusión (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22). Es así, como en el grupo general de embarazo múltiple, es decir con cervicometria normal o desconocida, parece claro que el uso de progesterona, ya sea natural o sintética, no tiene mayor utilidad.…”

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Prevención de Parto Prematuro en Gemelar: ¿Qué hay de nuevo?

Niklitschek

Lizana

2017

Rev. chil. obstet. ginecol.

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RESUMENLa incidencia del embarazo gemelar ha aumentado en todo el mundo de manera significativa en los últimos años. Uno de los principales problemas asociados es la prematurez, la cual afecta prácticamente al 50% de los embarazos gemelares, y es la causa única más importante de morbilidad y mortalidad perinatal. En este contexto cobran cada vez mas importancia las medidas de prevención del parto prematuro. En el embarazo único, existe evidencia sólida para recomendar el uso de múltiples estrategias de prevención, con resultados alentadores. En gestaciones múltiples en cambio, la información es menor y los resultados menos prometedores. Este articulo tiene como objetivo revisar la evidencia disponible sobre diferentes técnicas de prevención del parto prematuro en embarazos gemelares. ABSTRACTThe incidence of twin pregnancy has increased significantly worldwide in recent years. One of the main associated problems is prematurity, which affects almost 50% of twin pregnancies, and is the single most important cause of perinatal morbidity and mortality. In this context, measures of prevention of preterm delivery are becoming increasingly important. In single pregnancy, there is strong evidence to recommend the use of multiple prevention strategies, with encouraging results. In multiple gestations, the information is smaller and the results less promising. This article aims to review available evidence on different techniques for preventing preterm birth in twin pregnancies. El parto prematuro es la causa única más importante de morbilidad y mortalidad perinatal. Excluidas las malformaciones congénitas, el 75% de las muertes perinatales son atribuibles a prematurez, siendo en globo el riesgo de muerte de un prematuro 20 veces mayor que el de un RN de término (3). Por otra parte, la edad gestacional al parto juega también un rol esencial en el pronóstico perinatal, así la prematurez menor de 32 semanas, conlleva la mayor morbimortalidad neonatal y la mayor tasa de secuelas. En Estados Unidos los embarazos gemelares a pesar de corresponder solo al 3% del total de nacimientos, explican el 23% de los partos La incidencia del embarazo gemelar ha aumentado en todo el mundo de manera significativa en los últimos años. En Chile, se ha observado un incremento del 11% en los últimos 9 años, esto probablemente explicado por el aumento del uso de técnicas de reproducción asistida y un desplazamiento de la maternidad hacia edades mayores de la mujer (1). Lo anterior, cobra gran relevancia al recordar que el embarazo múltiple es de alto riesgo obstétrico, concentrando el 15% de la morbilidad perinatal total.Uno de los principales problemas asociados es la prematurez, la cual afecta prácticamente al 50% de los embarazos gemelares (2).

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RETRACTED ARTICLE: Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety

Cited by 62 publications

References 27 publications

Effect of vaginal progesterone in combination with cervical cerclage on improved gestational age and perinatal outcome in twin pregnancy: A prospective randomized study

Effect of vaginal progesterone in combination with cervical cerclage on improved gestational age and perinatal outcome in twin pregnancy: A prospective randomized study

Comment to the letter: The effects of progesterone in women undergoing preterm labor

Prevención de Parto Prematuro en Gemelar: ¿Qué hay de nuevo?

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