A Comparative, Randomized Control Trial in Patients of Per Vaginal Bleeding Comparing Efficacy of Oral Dydrogesterone Versus Vaginal Progesterone in Successful Pregnancy Outcome for Patients with Recurrent Pregnancy Loss.

BACKGROUND: Progesterone is essential for the maintenance of a healthy pregnancy. Any defect in the secretion of human chorionic gonadotropin or progesterone is associated with a significantly increased risk of first-trimester abortion. Progesterone is frequently prescribed to patients presenting with per vaginal (PV) bleeding in early pregnancy and a history of recurrent pregnancy loss.
METHODS: Pregnant women up to 12 weeks of gestation with a history of more than two early pregnancy losses and presenting with vaginal bleeding were included in this study. All subjects were randomized to receive either vaginal progesterone 600 mg/day or oral dydrogesterone 30 mg/day. A detailed history-including menstrual history, previous pregnancies, previous miscarriages, and other risk factors-was obtained. The mean time required for the cessation of PV bleeding and continuation of pregnancy up to 24 weeks and till term was compared.
RESULTS: A total of 200 patients were randomized to vaginal progesterone 600 mg/day (n = 100) or oral dydrogesterone 30 mg/day (n = 100). While 74 patients had two miscarriages in the progesterone group, 68 patients had two miscarriages in the dydrogesterone group. The time required for complete cessation of bleeding was significantly lesser among patients who received oral dydrogesterone compared to those who received intravaginal progesterone (53.90 ± 9.09 vs. 94.60 ± 7.29 h, p < 0.0001). Numerically higher number of patients receiving oral dydrogesterone had a successful continuation of pregnancy up to 24 weeks of gestation, as well as till full term compared to progesterone group (70 vs. 75).
CONCLUSION: Oral dydrogesterone is preferred over vaginal progesterone in patients presenting with vaginal bleeding during early pregnancy and a history of recurrent early pregnancy loss. © Federation of Obstetric & Gynecological Societies of India 2021.