Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial
Article first published online: 16 NOV 2009
Copyright © 2009 ISUOG. Published by John Wiley & Sons, Ltd.
Ultrasound in Obstetrics & Gynecology
Volume 34, Issue 6, pages 653–659, December 2009
How to Cite
O'Brien, J. M., DeFranco, E. A., Adair, C. D., Lewis, D. F., Hall, D. R., How, H., Bsharat, M. and Creasy, G. W. (2009), Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol, 34: 653–659. doi: 10.1002/uog.7338
- Issue published online: 1 DEC 2009
- Article first published online: 16 NOV 2009
- Manuscript Accepted: 23 FEB 2009
- Columbia Laboratories, Inc., Livingston, NJ, USA
- cervical length;
- premature cervical shortening;
- preterm birth;
To determine whether progesterone supplementation alters cervical shortening in women at increased risk for preterm birth.
We performed a planned secondary analysis from a large, multinational preterm birth prevention trial of daily intravaginal progesterone gel, 90 mg, com- pared with placebo in women with a history of spontaneous preterm birth or premature cervical shortening. Transvaginal cervical length measurements were obtained in all randomized patients at baseline (18 + 0 to 22 + 6 weeks' gestation) and at 28 weeks' gestation. For this secondary analysis, the difference in cervical length between these time points was compared for the study population with a history of spontaneous preterm birth and for a population with premature cervical shortening (≤ 30 mm) at randomization. Differences between groups in cervical length for the 28-week examination were analyzed using ANCOVA, including adjustment for relevant clinical parameters and maternal characteristics.
Data were analyzed from 547 randomized patients with a history of preterm birth. The progesterone-treated patients had significantly less cervical shortening than the placebo group (difference 1.6 (95% CI, 0.3–3.0) mm; P = 0.02, ANCOVA). In the population of 104 subjects with premature cervical shortening at randomization, the cervical length also differed significantly on multivariable analysis, with the treatment group preserving more cervical length than the placebo group (difference 3.3 (95% CI, 0.3–6.2) mm; P = 0.03, ANCOVA), with adjustment for differences in cervical length at screening. A significant difference was also observed between groups for categorical outcomes including the frequency of cervical length progression to ≤ 25 mm and a ≥ 50% reduction in cervical length from baseline in this subpopulation.
Intravaginal progesterone enhances preservation of cervical length in women at high risk for preterm birth. Copyright © 2009 ISUOG. Published by John Wiley & Sons, Ltd.