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Cited by 923Preterm Birth and ChorioamnionitisInfant Development and Preterm CareNeonatal Respiratory Health Research

Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double‐blind, placebo‐controlled trial

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Hassan, S. S., Romero, R., Vidyadhari, D., Fusey, S., Baxter, J. K., Khandelwal, M., Vijayaraghavan, J., Trivedi, Y. +18 more·2011·Ultrasound in Obstetrics & Gynecology
DOI 10.1002/uog.9017PMC PMC3482512
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Abstract

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

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  • Meta-analyses of randomized controlled trials of women with singleton gestation, no prior spontaneous preterm birth and transvaginal sonographic CL <25mm before 24 weeks have shown that administration of vaginal progesterone significantly decreases the risk of preterm birth and neonatal morbidity.

    “Meta-analyses of randomized controlled trials of women with singleton gestation, no prior spontaneous preterm birth and transvaginal sonographic CL &lt; 25mm before 24weeks have shown that administration of vaginal progesterone significantly decreases the risk of preterm birth and neonatal morbidity 99-101 .”

    From <scp>ISUOG</scp> Practice Guidelines (updated): performance of the routine mid‐trimester fetal ultrasound scan (2022) · cites this paper as [101]

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Authors
Hassan, S. S., Romero, R., Vidyadhari, D., Fusey, S., Baxter, J. K., Khandelwal, M., Vijayaraghavan, J., Trivedi, Y., Soma‐Pillay, P., Sambarey, P., Dayal, A., Potapov, V., O'Brien, J., Astakhov, V., Yuzko, O., Kinzler, W., Dattel, B., Sehdev, H., Mazheika, L., Manchulenko, D., Gervasi, M. T., Sullivan, L., Conde‐Agudelo, A., Phillips, J. A., Creasy, G. W., & Trial, F. T. P.
Affiliations
  • National Institutes of Health (US)
  • Mediciti Institute of Medical Sciences (IN)
  • Government of Maharashtra (IN)
  • Thomas Jefferson University (US)
  • Cooper University Hospital (US)
  • Sri Ramachandra Institute of Higher Education and Research (IN)
  • Steve Biko Hospital (ZA)
  • B. J. Medical College & Sassoon Hospital (IN)
  • Albert Einstein College of Medicine (US)
  • Dnipro State Medical University (UA)
  • Donetsk National Medical University (UA)
  • Shupyk National Healthcare University of Ukraine (UA)
  • Winthrop-University Hospital (US)
  • Eastern Virginia Medical School (US)
  • Pennsylvania Hospital (US)
  • Azienda Ospedale - Università Padova (IT)
  • Boston University (US)
Corresponding author
Romero, R.
ORCID
Venue
Ultrasound in Obstetrics & Gynecology
Publisher
Wiley
Published
2011-06-15
Volume
38
Issue
1
Pages
18-31
ISSN
  • 0960-7692 (ISSN-L)
  • 1469-0705
DOI
10.1002/uog.9017
PMC
PMC3482512
OpenAlex
W2144171496
Cited by
923
References
113
Citations by year
2026: 34 · 2025: 23 · 2024: 28 · 2023: 34 · 2022: 43 · 2021: 54 · 2020: 70 · 2019: 52 · 2018: 52 · 2017: 137 · 2016: 74 · 2015: 59 · 2014: 63 · 2013: 76 · 2012: 82
FWCI
60.72
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Ultrasound in Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (ZIAHD002401)
Topics
  • Health Sciences › Medicine › Epidemiology › Preterm Birth and Chorioamnionitis
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
Keywords
vaginal progesterone, short cervix, preterm birth, preterm birth prevention, cervical length, respiratory distress syndrome, neonatal complications, singleton pregnancy
MeSH terms
Administration, Intravaginal, Adolescent, Adult, Cervix Uteri, Double-Blind Method, Female, Humans, Placebos, Pregnancy, Pregnancy Outcome, Progestins, Progesterone, Prospective Studies, Ultrasonography, Vagina, Vaginal Creams, Foams, and Jellies, Pregnancy, High-Risk, Premature Birth, Young Adult

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