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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
Open accessAbstract
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 24weeks have shown that administration of vaginal progesterone significantly decreases the risk of preterm birth and neonatal morbidity 99-101 .”
From ISUOG Practice Guidelines (updated): performance of the routine mid‐trimester fetal ultrasound scan (2022) · cites this paper as [100]
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ISUOG Practice Guidelines (updated): performance of the routine mid‐trimester fetal ultrasound scan
Salomon, L. J., Alfirevic, Z., Berghella, V., Bilardo, C. M., Chalouhi, G. E., Da Silva Costa, F., Hernandez‐Andrade, E., Malinger, G., Munoz, H., Paladini, D., et al. (2022) · Ultrasound in Obstetrics & Gynecology · doi:10.1002/uog.24888 · Cited by 436
Prediction and Prevention of Spontaneous Preterm Birth
(2021) · Obstetrics & Gynecology · doi:10.1097/aog.0000000000004479 · Cited by 377
The exciting potential for ChatGPT in obstetrics and gynecology
Grünebaum, A., Chervenak, J., Pollet, S. L., Katz, A., & Chervenak, F. A. (2023) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2023.03.009 · Cited by 234
Stewart, L. A., Simmonds, M. C., Duley, L., Llewellyn, A., Sharif, S., Walker, R., Beresford, L., Wright, K. E., Aboulghar, M. M., Alfirević, Ž., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00217-8 · Cited by 248
Self-citationProgesterone-Related Immune Modulation of Pregnancy and Labor
Shah, N. M., Lai, P. F., Imami, N., & Johnson, M. R. (2019) · Frontiers in Endocrinology · doi:10.3389/fendo.2019.00198 · Cited by 225
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
- 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)
- 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
- bronze
- doi.org
- 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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