Progesterone and the Risk of Preterm Birth among Women with a Short Cervix
Eduardo B. Fonseca, M.D., Ebru Celik, M.D., Mauro Parra, M.D., Mandeep Singh, M.D., Kypros H. Nicolaides, M.D., for the Fetal Medicine Foundation Second Trimester Screening Group
Background Previous randomized trials have shown that progesteroneadministration in women who previously delivered prematurelyreduces the risk of recurrent premature delivery. Asymptomaticwomen found at midgestation to have a short cervix are at greatlyincreased risk for spontaneous early preterm delivery, and itis unknown whether progesterone reduces this risk in such women.
Methods Cervical length was measured by transvaginal ultrasonographyat a median of 22 weeks of gestation (range, 20 to 25) in 24,620pregnant women seen for routine prenatal care. Cervical lengthwas 15 mm or less in 413 of the women (1.7%), and 250 (60.5%)of these 413 women were randomly assigned to receive vaginalprogesterone (200 mg each night) or placebo from 24 to 34 weeksof gestation. The primary outcome was spontaneous delivery before34 weeks.
Results Spontaneous delivery before 34 weeks of gestation wasless frequent in the progesterone group than in the placebogroup (19.2% vs. 34.4%; relative risk, 0.56; 95% confidenceinterval [CI], 0.36 to 0.86). Progesterone was associated witha nonsignificant reduction in neonatal morbidity (8.1% vs. 13.8%;relative risk, 0.59; 95% CI, 0.26 to 1.25; P=0.17). There wereno serious adverse events associated with the use of progesterone.
Conclusions In women with a short cervix, treatment with progesteronereduces the rate of spontaneous early preterm delivery. (ClinicalTrials.govnumber, NCT00422526
[ClinicalTrials.gov]
.)
Source Information
From the Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London.
Address reprint requests to Dr. Nicolaides at the Harris Birthright Research Centre for Fetal Medicine, King's College Hospital Medical School, Denmark Hill, London SE5 8RX, United Kingdom, or at kypros{at}fetalmedicine.com.
Progesterone and Preterm Birth
O'Brien J. M., Chandiramani M., Tribe R., Shennan A., Nicolaides K. H., Celik E., Fonseca E. B., Rouse D. J., Thom E. A., Spong C. Y., the NICHD Maternal Fetal Medicine Units Network
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N Engl J Med 2007;
357:2306-2307, Nov 29, 2007.
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