Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial - Hassan - Ultrasound in Obstetrics & Gynecology - Wiley Online Library

Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial
Sonia S. Hassan1,2, Roberto Romero1,3,*, Dommeti Vidyadhari4, Shalini Fusey5, Jason Baxter6, Meena Khandelwal7, Jaya Vijayaraghavan8, Yamini Trivedi9, Priya Soma-Pillay10, Pradip Sambarey11, Ashlesha Dayal12, Valentin Potapov13, John O'Brien14, Vladimir Astakhov15, Oleksandr Yuzko16, Wendy Kinzler17, Bonnie Dattel18, Harish Sehdev19, Liudmila Mazheika20, Dmitriy Manchulenko21, Maria Teresa Gervasi22, Lisa Sullivan23, Agustin Conde-Agudelo1, James A. Phillips24, George W. Creasy25, for the PREGNANT Trial
DOI: 10.1002/uog.9017

Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.

Abstract
Background:
Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the efficacy and safety of micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix.

Methods:
This was a multicenter, randomized, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10 to 20 mm) at 19 - 23 6/7 weeks of gestation. Women were randomly allocated to receive vaginal progesterone gel or placebo daily from 20 – 23 6/7 weeks until 36 6/7 weeks, rupture of membranes, or delivery, whichever occurred first. Randomization sequence was stratified by center and history of a previous preterm birth. The primary endpoint was preterm birth before 33 weeks of gestation. Analysis was by intention to treat.

Findings:
Of 465 women randomized, seven were lost to follow-up and 458 (vaginal progesterone gel, n = 235; placebo, n = 223) were included in the analysis. Women allocated to receive vaginal progesterone had a lower rate of preterm birth before 33 weeks than those allocated to placebo (8.9% [n = 21] vs 16.1% [n = 36], relative risk [RR] 0.55, 95% confidence interval [CI] 0.33-0.92, p = 0.02). The effect remained significant after adjustment for co-variables (adjusted RR 0.52, 95% CI 0.31-0.91, p= 0.02). Vaginal progesterone was also associated with a significant reduction in the rate of preterm birth before 28 (5.1% vs 10.3%, RR 0.50, 95% CI 0.25-0.97, p = 0.04) and 35 weeks (14.5% vs 23.3% RR 0.62, 95% CI 0.42-0.92, p = 0.02), respiratory distress syndrome (3.0% vs 7.6% RR 0.39, 95% CI 0.17-0.92, p = 0.03), any neonatal morbidity or mortality event (7.7% vs 13.5% RR 0.57, 95% CI 0.33-0.99, p = 0.04), and birth weight <1500 g (6.4% [15/234] vs 13.6% [30/220], RR 0.47, 95% CI 0.26-0.85, p=0.01). There were no differences in the incidence of treatment-related adverse events between the groups.

Interpretation:
The administration of vaginal progesterone gel to women with a sonographic short cervix in the midtrimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation, and improved neonatal outcomes.

Funding:
Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health and Columbia Laboratories, Inc. Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.



Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial - Hassan - Ultrasound in Obstetrics & Gynecology - Wiley Online Library




OBSTETRICIA
Actualidad Ultimas noticias - JANOes -
Un gel de progesterona reduce los nacimientos prematuros en un 45%
JANO.es · 03 Mayo 2011 09:26

.Investigadores de los Institutos Nacionales de Salud de Estados Unidos publican haber hallado un tratamiento sencillo con el que prevenir este problema en gestantes con cuello uterino corto.



El tratamiento con progesterona enmujeres embarazadas de alto riesgo redujo su tasa de parto prematuro en 45% y ayudó a disminuir el riesgo de complicaciones respiratorias de sus hijos, según un estudio que ha evaluado un gel vaginal, publicado por investigadores estadounidenses en Ultrasound in Obstetrics and Gynecology. La investigación aumenta las esperanzas de lograr una forma sencilla de prevenir el parto prematuro en mujeres con cuello uterino corto.

"En todo el mundo, nacen cada año más de 12 millones de prematuros y los resultados son a menudo trágicos. Nuestro estudio clínico muestra claramente que es posible identificar mujeres en riesgo y reducir la tasa de parto prematuro en cerca de la mitad, por el simple hecho de tratar a las mujeres que tienen cuello uterino corto con una hormona natural, la progesterona", indicó el Dr. Romero, de los Institutos Nacionales de Salud (NIH) de Estados Unidos.

Los niños que nacen muy temprano -antes de la semana número 33 del embarazo- tienen un mayor riesgo de muerte y problemas de salud y de desarrollo a largo plazo. En el estudio, investigadores de los NIH y 44 centros médicos de todo el mundo evaluaron los efectos de administrar progesterona a mujeres con cuello uterino corto.

Los investigadores sospechan que las mujeres con un cuello del útero corto pueden no tener suficientes niveles de esta hormona y pensaron que administrarla durante el embarazo en forma de gel podría ayudar a prolongar la gestación.

El equipo estudió 458 mujeres con cuello uterino corto que recibieron el gel vaginal con progesterona o placebo entre las semanas 19 y 23 del embarazo. Sólo el 8,9% de las mujeres que recibieron el gel dieron a luz antes de la semana 33 del embarazo, en comparación con 16,1% del grupo placebo.

El tratamiento también ayudó a los recién nacidos. Sólo el 3% de los nacidos de mujeres tratadas con progesterona presentaron dificultades respiratorias en comparación con el 7,6% en el grupo placebo.


National Institutes of Health
National Institutes of Health (NIH)

Ultrasound in Obstetrics & Gynecology
Ultrasound in Obstetrics & Gynecology - Wiley Online Library

Ultrasound in Obstetrics and Gynecology 2001;DOI: 10.1002/uog.901
Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial - Hassan - Ultrasound in Obstetrics & Gynecology - Wiley Online Library


Actualidad Ultimas noticias - JANOes - Un gel de progesterona reduce los nacimientos prematuros en un 45 - JANO.es - ELSEVIER