Comparison of two different vaginal preparations of progesterone for prevention of recurrent preterm birth: a Randomized Controlled Trial

INTERVENTION: Intervention1: 200 milligrams of micronized progesterone effervescent vaginal tablet: The effervescent vaginal tablet, contains progesterone in a base of sodium bicarbonate, and an acid‐base reaction occurs when the tablet comes into contact with vaginal moisture, thus releasing carbon dioxide, which improves drug absorption across epithelium. As a result, this formulation has rapid dissolution and quick progesterone absorption. It will be given daily, per vaginally, from (16‐20 weeks Period of Gestation) till delivery Control Intervention1: 200 milligram of micronized progesterone gelatin capsule, vaginally: With repeated administration, the vaginal gel will build up in the vagina and will release progesterone gradually. It will be given daily, per vaginally, from (16‐20 weeks Period of Gestation) till delivery CONDITION: Health Condition 1: O092‐ Supervision of pregnancy with other poor reproductive or obstetric history PRIMARY OUTCOME: To compare micronized progesterone effervescent vaginal tablet with micronized progesterone gelatin capsule used vaginally, for prevention of PTB less than 37 weeks, in women with a prior spontaneous PTB or a mid‐trimester abortion.Timepoint: Till the delivery SECONDARY OUTCOME: 1 To compare the incidence of PTB less than and equal to 32 weeks (very PTB) and less than and equal to 28 weeks (extreme PTB) in the above two groups ; Timepoint: Preterm delivery less than and equal to 32 weeks and 28 weeks respectively To compare the acceptability and tolerability of the two progesterone formulations ; Timepoint: At least 15 days after using the progesterone formulations and later whenever the women complain INCLUSION CRITERIA: 1. Singleton live pregnancy between 16 to 20 weeks. 2. At least one spontaneous mid‐trimester abortion or preterm birth (â?¥16 weeks PoG to <37 weeks PoG) of a singleton infant due to spontaneous Preterm labor or Preterm premature rupture of membranes.