Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix : a multicenter, randomized, double-blind, placebo-controlled trial
Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd..
OBJECTIVES: 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 using 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, double-blind, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10-20 mm) at 19 + 0 to 23 + 6 weeks of gestation. Women were allocated randomly to receive vaginal progesterone gel or placebo daily starting from 20 to 23 + 6 weeks until 36 + 6 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.
RESULTS: 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 did those allocated to placebo (8.9% (n=21) vs 16.1% (n=36); relative risk (RR), 0.55; 95% CI, 0.33-0.92; P=0.02). The effect remained significant after adjustment for covariables (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 weeks (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.
CONCLUSIONS: The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome.
Errataetall: |
CommentIn: Ultrasound Obstet Gynecol. 2011 Jul;38(1):1-9. - PMID 21713990 |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2011 |
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Erschienen: |
2011 |
Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
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Enthalten in: |
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology - 38(2011), 1 vom: 02. Juli, Seite 18-31 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Hassan, S S [VerfasserIn] |
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Links: |
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Anmerkungen: |
Date Completed 12.09.2011 Date Revised 10.04.2022 published: Print-Electronic CommentIn: Ultrasound Obstet Gynecol. 2011 Jul;38(1):1-9. - PMID 21713990 Citation Status MEDLINE |
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doi: |
10.1002/uog.9017 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM207282226 |
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245 | 1 | 0 | |a Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix |b a multicenter, randomized, double-blind, placebo-controlled trial |
264 | 1 | |c 2011 | |
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500 | |a CommentIn: Ultrasound Obstet Gynecol. 2011 Jul;38(1):1-9. - PMID 21713990 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd. | ||
520 | |a OBJECTIVES: 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 using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix | ||
520 | |a METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10-20 mm) at 19 + 0 to 23 + 6 weeks of gestation. Women were allocated randomly to receive vaginal progesterone gel or placebo daily starting from 20 to 23 + 6 weeks until 36 + 6 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 | ||
520 | |a RESULTS: 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 did those allocated to placebo (8.9% (n=21) vs 16.1% (n=36); relative risk (RR), 0.55; 95% CI, 0.33-0.92; P=0.02). The effect remained significant after adjustment for covariables (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 weeks (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 | ||
520 | |a CONCLUSIONS: The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome | ||
650 | 4 | |a Clinical Trial, Phase III | |
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650 | 4 | |a Research Support, N.I.H., Intramural | |
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650 | 7 | |a Progestins |2 NLM | |
650 | 7 | |a Vaginal Creams, Foams, and Jellies |2 NLM | |
650 | 7 | |a Progesterone |2 NLM | |
650 | 7 | |a 4G7DS2Q64Y |2 NLM | |
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700 | 1 | |a Vijayaraghavan, J |e verfasserin |4 aut | |
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700 | 1 | |a O'Brien, J |e verfasserin |4 aut | |
700 | 1 | |a Astakhov, V |e verfasserin |4 aut | |
700 | 1 | |a Yuzko, O |e verfasserin |4 aut | |
700 | 1 | |a Kinzler, W |e verfasserin |4 aut | |
700 | 1 | |a Dattel, B |e verfasserin |4 aut | |
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700 | 1 | |a Conde-Agudelo, A |e verfasserin |4 aut | |
700 | 1 | |a Phillips, J A |e verfasserin |4 aut | |
700 | 1 | |a Creasy, G W |e verfasserin |4 aut | |
700 | 0 | |a PREGNANT Trial |e verfasserin |4 aut | |
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700 | 1 | |a Zanko, S |e investigator |4 oth | |
700 | 1 | |a Ortiz Castro, J |e investigator |4 oth | |
700 | 1 | |a Oyarzun, E |e investigator |4 oth | |
700 | 1 | |a Calda, P |e investigator |4 oth | |
700 | 1 | |a Fusey, S |e investigator |4 oth | |
700 | 1 | |a Sambarey, P |e investigator |4 oth | |
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700 | 1 | |a Vidyadhari, D |e investigator |4 oth | |
700 | 1 | |a Vijayaraghavan, J |e investigator |4 oth | |
700 | 1 | |a Bashiri, A |e investigator |4 oth | |
700 | 1 | |a Hazan, Y |e investigator |4 oth | |
700 | 1 | |a Hendler, I |e investigator |4 oth | |
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700 | 1 | |a Soma-Pillay, P |e investigator |4 oth | |
700 | 1 | |a Astakhov, V |e investigator |4 oth | |
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700 | 1 | |a Artal, R |e investigator |4 oth | |
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