VAGINAL PROGESTERONE ADMINISTRATION FOR WOMEN AT RISK OF PRETERM BIRTH WITH A SHORT CERVIX
Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University
Objective: This is a randomized trial to evaluate the effect of vaginal progesterone on the frequency of spontaneous early preterm delivery in asymptomatic women with short cervix during mid-trimester transvaginal sonography (TVS) screening.
Methods: All women with singleton pregnancies at-risk of preterm labor presenting to obstetrics clinic, Kasr El-Aini University from May 2004 to June 2006 were assessed with TVS between 20 and 28 weeks. Women with cervical length < 25 mm (n = 42) were included in the treatment trial and randomized into one of two treatment groups; group 1 (n = 23) received Utergestan vaginal tablets 100 mg twice daily until 34 weeks and group 2 (n = 19) did not receive any treatment apart from modified bed rest, stopping smoking, abstain sexual activity. The primary outcome measure was spontaneous delivery before 34 completed weeks of gestation. The secondary outcome measures were spontaneous delivery before 37 weeks, birth weight and fetal or neonatal death.
Results: No significant difference in median cervical length between the 2 groups (p = 0.493). The proportion of spontaneous delivery before 34 weeks was 8.7% in group 1 and 26.3% in group 2 (p = 0.214). The proportion of delivery before 37 weeks was 21.7% in group 1 and 52.6% in group 2 (p = 0.038, Odds Ratio 0.50, 95% CI: 0.23-1.07). The proportion of small for gestational age infants was rather high in both groups, but not statistically significant (p = 0.273). No fetal or neonatal deaths were recorded.
Conclusion: Vaginal administration of natural micronized progesterone starting during second trimester seems to be an effective and safe measure for preventing preterm delivery, especially before 37 weeks in women with cervical length < 25 mm measured with TVS.