Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis - 27/06/18
, Eduardo Da Fonseca, MD f, John M. O’Brien, MD g, Elcin Cetingoz, MD h, George W. Creasy, MD i, Sonia S. Hassan, MD a, b, Offer Erez, MD a, b, j, Percy Pacora, MD a, b, Kypros H. Nicolaides, MD kAbstract |
Background |
An indirect comparison meta-analysis published in 2013 reported that both vaginal progesterone and cerclage are equally efficacious for preventing preterm birth and adverse perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a sonographic short cervix. The efficacy of vaginal progesterone has been challenged after publication of the OPPTIMUM study. However, this has been resolved by an individual patient-data meta-analysis (Am J Obstet Gynecol. 2018;218:161-180).
Objective |
To compare the efficacy of vaginal progesterone and cerclage in preventing preterm birth and adverse perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a midtrimester sonographic short cervix.
Data Sources |
MEDLINE, EMBASE, LILACS, and CINAHL (from their inception to March 2018); Cochrane databases, bibliographies, and conference proceedings.
Study Eligibility Criteria |
Randomized controlled trials comparing vaginal progesterone to placebo/no treatment or cerclage to no cerclage in women with a singleton gestation, previous spontaneous preterm birth, and a sonographic cervical length <25 mm.
Study Appraisal and Synthesis Methods |
Updated systematic review and adjusted indirect comparison meta-analysis of vaginal progesterone vs cerclage using placebo/no cerclage as the common comparator. The primary outcomes were preterm birth <35 weeks of gestation and perinatal mortality. Pooled relative risks (RRs) with 95% confidence intervals were calculated.
Results |
Five trials comparing vaginal progesterone vs placebo (265 women) and 5 comparing cerclage vs no cerclage (504 women) were included. Vaginal progesterone, compared to placebo, significantly reduced the risk of preterm birth <35 and <32 weeks of gestation, composite perinatal morbidity/mortality, neonatal sepsis, composite neonatal morbidity, and admission to the neonatal intensive care unit (RRs from 0.29 to 0.68). Cerclage, compared to no cerclage, significantly decreased the risk of preterm birth <37, <35, <32, and <28 weeks of gestation, composite perinatal morbidity/mortality, and birthweight <1500 g (RRs from 0.64 to 0.70). Adjusted indirect comparison meta-analyses did not show statistically significant differences between vaginal progesterone and cerclage in the reduction of preterm birth or adverse perinatal outcomes.
Conclusion |
Vaginal progesterone and cerclage are equally effective for preventing preterm birth and improving perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a midtrimester sonographic short cervix. The choice of treatment will depend on adverse events and cost-effectiveness of interventions and patient/physician’s preferences.
Le texte complet de cet article est disponible en PDF.Key words : admission to neonatal intensive care unit, birthweight <1500 g, cervical length, cervical stitch, perinatal mortality, prematurity, progestin, progestogens, recurrent preterm birth, transvaginal ultrasound, uterine cervix
Plan
| The funder had no role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. |
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| This research was supported, in part, by the Perinatology Research Branch, 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. |
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| Dr O’Brien was involved in studies of progesterone gel treatment for preterm birth prevention sponsored by a maker of progesterone gel. He served on advisory boards and as a consultant for Watson Pharmaceuticals, a company with a financial interest in marketing vaginal progesterone gel for preterm birth prevention; he and others are listed in a patent on the use of progesterone compounds to prevent preterm birth (US patent 7884093: progesterone for the treatment and prevention of spontaneous preterm birth). He has received no royalty payments. Dr Creasy was an employee of Columbia Laboratories, Inc when the previous indirect comparison meta-analysis was conducted in 2012. The other authors report no conflict of interest. |
Vol 219 - N° 1
P. 10-25 - juillet 2018 Retour au numéro
Article précédent
- Vaginal progesterone is an alternative to cervical cerclage in women with a short cervix and a history of preterm birth
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