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

Romero, Roberto; Conde-Agudelo, Agustin; Da Fonseca, Eduardo; O’Brien, John M.; Cetingoz, Elcin; Creasy, George W.; Hassan, Sonia S.; Nicolaides, Kypros H.

doi:10.1016/j.ajog.2017.11.576

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

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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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 < 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 [100]

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Vaginal progesterone decreases preterm birth ≤ 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta‐analysis including data from the OPPTIMUM study
Romero, R. J., Nicolaides, K. H., Conde‐Agudelo, A., O’Brien, J., Çetingöz, E., da Fonseca, E. B., Creasy, G. W., & Hassan, S. S. (2016) · Ultrasound in Obstetrics and Gynecology · doi:10.1002/uog.15953 · Cited by 256 · see citing works
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Effects of vaginal progesterone and placebo on preterm birth and antenatal outcomes in women with singleton pregnancies and short cervix on ultrasound: a meta-analysis
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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: Romero, Roberto
O’Brien, John M.
Creasy, George W.
Hassan, Sonia S.
Nicolaides, Kypros H.
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 · 2016: 1
FWCI: 5.33
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (am, 370 d)
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 › 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, 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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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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