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Abstract P rogesterone is a steroid hormone that helps to maintain pregnancy. Removal of progesterone, or blockage of its receptors, reliably ends pregnancy at all gestational ages, and in many non-human species, falling levels precipitate natural labor. Objective: It aimed to test the effect of vaginal natural progesterone on prevention of pre-term birth after either IVF/ ICSI pregnancies through a randomized controlled trial. Patient and method: The study included 150 pregnant women selected on basis of being healthy pregnant women with normal uterine, cervical and fetal anatomy, who conceived after IVF/ICSI between 18-24 weeks of gestation, singleton pregnancies. Exclusion criteria: The women are excluded for Serious fetal anomalies for which termination may be considered (major heart anomaly, CNS anomalies such asanencephaly & spina bifida. Multiple pregnancies, uterine anomalies (unicornuate, septal and bicornuate uterus. Cervical cerclage, ante-partum ROM, cervical incompetence, cerclage, congenital fetal malformations, hypertension requiring medications, progesterone or heparin therapy or history of thrombo-embolic disorders, known liver disease and progesterone allergy. The pregnant women were randomly arranged by closed envelop method into two groups, (progesterone group and placebo group), 75 women in case (progesterone) group & 75 women in control (placebo) group. Progesterone and placebo pessaries are identical in color and shape. Results: There was no statistically significant difference between both groups as regarding to age, parity, body mass index, number of previous preterm labor and occupation of the mothers. In the current study, fewer women in progesterone group reported low birth weight babies (< 1500 gm) 9.33 % compared with 20% in placebo group and the difference is statistically significant. In the current study, the gestational age at delivery was lower in placebo group (mean 36 ± 2.8 weeks) compared to progesterone group (mean 37.2 ± 1.7 weeks) and the difference is highly statistically significant. The average gestational age for those who had preterm birth was 34.3 ±1.4 weeks in the progesterone group and 32.6 ±2.1 weeks in the placebo group and the difference is also highly statistically significant. In the current study, the frequency of neonatal death was more frequently found in the placebo group (16%) than in the progesterone group (2.67%) and the difference was highly statistically significant. In the study group there was an insignificant trend towards IUGR and 2nd trimester abortion. But significant trend towards PROMS, so progesterone may thus delay vaginal bleeding in some patient but it does not prevent miscarriage. |