Conflict of interest The authors have stated explicitly that there are no conflicts of interest in connection with this article.
Main Research Article
Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone
Article first published online: 5 DEC 2012
© 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology
Acta Obstetricia et Gynecologica Scandinavica
Volume 92, Issue 2, pages 215–222, February 2013
How to Cite
MAHER, M. A., ABDELAZIZ, A., ELLAITHY, M. and BAZEED, M. F. (2013), Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstetricia et Gynecologica Scandinavica, 92: 215–222. doi: 10.1111/aogs.12017
Please cite this article as: Maher MA, Abdelaziz A, Ellaithy M, Bazeed MF. Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstet Gynecol Scand 2012; 91:DOI: 10.1111/aogs.12017.
- Issue published online: 23 JAN 2013
- Article first published online: 5 DEC 2012
- Accepted manuscript online: 27 SEP 2012 08:58AM EST
- Received: 20 March 2011 Accepted: 17 September 2012
- Intramuscular progesterone;
- preterm birth;
- vaginal progesterone
Objective. To assess efficacy and tolerability of vaginal compared with intramuscular progesterone in reducing the rate of recurrent preterm birth before 34 weeks of gestation. Design. Prospective randomized study. Setting. Obstetrics and Gynecology Department, Armed Forces Hospital Southern Region, Kingdom of Saudi Arabia. Sample. Five-hundred and eighteen women with a prior history of preterm birth. Methods. Women were randomized to receive either 90 mg of vaginal progesterone gel once daily or 250 mg of intramuscular progesterone weekly. Treatment began between 14 and 18 weeks of gestation and continued until 36 complete weeks of gestation, delivery or the occurrence of premature rupture of membranes. Main outcome measures. The primary outcome measure was delivery before 34 weeks of gestation. The secondary outcome measures were PTB between 34 and 37 weeks of gestation and neonatal outcomes including birthweight, neonatal death, and the need for admission to the neonatal intensive care unit. Results. The baseline characteristics of the study participants were similar. Two-hundred and thirty-eight (94.1%) patients in the vaginal group and 226 (90.8%) patients in the intramuscular group were compliant with their medications. Vaginal progesterone was associated with a lower percentage of deliveries before 34 weeks of gestation than the intramuscular preparation (p= 0.02). This association was also observed at 28 and 32 weeks of gestation (p= 0.04). Adverse effects were reported in 14.1% of patients in the intramuscular group, but in only 7.5% of patients in the vaginal group (p= 0.017). Conclusions. Vaginal progesterone was more effective than intramuscular progesterone for the prevention of preterm birth and had fewer adverse effects.