The Value of Oral Micronized Progesterone in the Prevention of Spontaneous Preterm Birth: A Randomized Control Trial.

Abstract

SUMMARY P reterm birth is the major cause of neonatal mortality and morbidity. A history of a prior spontaneous PTB remains the greatest risk factor for spontaneous PTB, These high- risk women have been the focus of recent trials for the prevention of recurrent prematurity. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%). Several trials have shown a reduction in spontaneous PTB using various formulations of progesterone, offering progesterone supplementation to women with a prior spontaneous PTB is now recommended by American College of Obstetricians and Gynecologists. Natural (micronized) progesterone is identical to the progesterone produced by the placenta and corpus luteum and so is readily metabolized and associated with minimal side effects. This was a randomized double blind clinical trial was carried out to evaluate the effectiveness of use of oral micronized progesterone in reduction of preterm birth in high risk women. This study included two hundred and twelve (212) pregnant women who were randomly assigned into two parallel groups, (progesterone and placebo group). Group A (progesterone group) included 103 patients and 3 women were lost to follow up, Group B (placebo group) included 102 patients and 4 women were lost to follow up. The subjects were randomized to receive twice daily capsules of either 100 mg of OMP (Utrocare®, October Pharma, Sixth of October city, Egypt) or placebo from enrollment (14–18 weeks) until 36 weeks or delivery. Primary outcome was the rate of preterm birth. There was no statistically significance difference between the two groups as regards age, parity, number of previous preterm labor and body mass index. There was a statistically significant reduction in the rate of preterm birth between the two groups from 63.7%in placebo group, compared with 44.7% in progesterone group. There was high significant increase in the average gestational age for those who had preterm birth from mean (33.40±2.44) weeks in placebo group compared to mean (35.17±2.07) weeks in the progesterone group. Although we used the oral route of progesterone administration, our results were similar to those of most compared studies which used the vaginal or intramuscular routes according to prolongation of gestational age at delivery, reducing of rate of preterm birth and improving of the neonatal outcome.