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Cited by 522Preterm Birth and ChorioamnionitisInfant Development and Preterm CareNeonatal Respiratory Health Research

The DOI matches its Crossref record; 194 of the 197 references it cites were found in a registry or an index.

Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix: a meta-analysis of individual patient data

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Romero, Roberto, Conde-Agudelo, Agustin, Da Fonseca, Eduardo, O’Brien, John M., Cetingoz, Elcin, Creasy, George W., Hassan, Sonia S., Nicolaides, Kypros H.·2018·American Journal of Obstetrics and Gynecology
DOI 10.1016/j.ajog.2017.11.576PMC PMC5987201
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Abstract

Background The efficacy of vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix has been questioned after publication of the OPPTIMUM study.Objective To determine whether vaginal progesterone prevents preterm birth and improves perinatal outcomes in asymptomatic women with a singleton gestation and a midtrimester sonographic short cervix.Study design We searched MEDLINE, EMBASE, LILACS, and CINAHL (from their inception to September 2017); Cochrane databases; bibliographies; and conference proceedings for randomized controlled trials comparing vaginal progesterone vs placebo/no treatment in women with a singleton gestation and a midtrimester sonographic cervical length ≤25 mm. This was a systematic review and meta-analysis of individual patient data. The primary outcome was preterm birth <33 weeks of gestation. Secondary outcomes included adverse perinatal outcomes and neurodevelopmental and health outcomes at 2 years of age. Individual patient data were analyzed using a 2-stage approach. Pooled relative risks with 95% confidence intervals were calculated. Quality of evidence was assessed using the GRADE methodology.Results Data were available from 974 women (498 allocated to vaginal progesterone, 476 allocated to placebo) with a cervical length ≤25 mm participating in 5 high-quality trials. Vaginal progesterone was associated with a significant reduction in the risk of preterm birth <33 weeks of gestation (relative risk, 0.62; 95% confidence interval, 0.47-0.81; P = .0006; high-quality evidence). Moreover, vaginal progesterone significantly decreased the risk of preterm birth <36, <35, <34, <32, <30, and <28 weeks of gestation; spontaneous preterm birth <33 and <34 weeks of gestation; respiratory distress syndrome; composite neonatal morbidity and mortality; birthweight <1500 and <2500 g; and admission to the neonatal intensive care unit (relative risks from 0.47-0.82; high-quality evidence for all). There were 7 (1.4%) neonatal deaths in the vaginal progesterone group and 15 (3.2%) in the placebo group (relative risk, 0.44; 95% confidence interval, 0.18-1.07; P = .07; low-quality evidence). Maternal adverse events, congenital anomalies, and adverse neurodevelopmental and health outcomes at 2 years of age did not differ between groups.Conclusion Vaginal progesterone decreases the risk of preterm birth and improves perinatal outcomes in singleton gestations with a midtrimester sonographic short cervix, without any demonstrable deleterious effects on childhood neurodevelopment.

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  1. Higgins J, Altman D, Sterne J. Chapter 8: Assessing risk of bias in included studies. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1. 0 (updated March 2011). The Cochrane Collaboration; 2011.
  2. Kuon, 2015, Progesterone for prevention of preterm birth–evidence-based indications, Z Geburtshilfe Neonatol, 219, 125

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Metadata

Authors
Romero, R., Conde-Agudelo, A., Da Fonseca, E., O’Brien, J. M., Cetingoz, E., Creasy, G. W., Hassan, S. S., & Nicolaides, K. H.
Affiliations
  • National Institutes of Health (US)
  • University of Kentucky (US)
  • Population Council (US)
  • Harris Birthright Research Centre for Fetal Medicine (GB)
Corresponding author
Romero, Roberto
ORCID
Venue
American Journal of Obstetrics and Gynecology
Publisher
Elsevier BV
Published
2018-02
Volume
218
Issue
2
Pages
161-180
ISSN
0002-9378 (ISSN-L)
DOI
10.1016/j.ajog.2017.11.576
PMC
PMC5987201
OpenAlex
W2768850026
Cited by
522
References
197
Citations by year
2026: 42 · 2025: 46 · 2024: 67 · 2023: 53 · 2022: 94 · 2021: 71 · 2020: 69 · 2019: 45 · 2018: 33
FWCI
5.33
Type
journal article
Language
en
Open access
Licence
Locations
  • American Journal of Obstetrics and Gynecology (acceptedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Perinatology Research Branch
  • Division of Obstetrics and Maternal-Fetal Medicine, Division of Intramural Research
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development
  • National Institutes of Health
  • Department of Health and Human Services
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › 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, preterm birth, short cervix, cervical length, singleton pregnancy, perinatal outcomes, respiratory distress syndrome, neonatal morbidity and mortality, neonatal intensive care admission, neurodevelopmental outcomes, preterm birth prevention, birth weight
MeSH terms
Administration, Intravaginal, Uterine Cervical Diseases, Female, Humans, Infant, Newborn, Pregnancy, Pregnancy Outcome, Progestins, Progesterone, Risk, Treatment Outcome, Premature Birth

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