Comparison of two different vaginal preparations of progesterone for prevention of recurrent preterm birth: A Randomized Controlled Trial
Phase 3
- Conditions
- Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history
- Registration Number
- CTRI/2023/01/048696
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Singleton live pregnancy between 16 to 20 weeks.
2. At least one spontaneous mid-trimester abortion or preterm birth (>=16 weeks PoG to <37 weeks PoG) of a singleton infant due to spontaneous Preterm labor or Preterm premature rupture of membranes.
Exclusion Criteria
1.Multifetal gestation
2.Known allergy to progesterone
3.Women with medical disorders (severe chronic hypertension, diabetes mellitus, heart disease, severe anaemia, collagen vascular disorders) which require additional treatment or may result in Preterm delivery
4.Major congenital malformation of the fetus.
5.Women with short cervical length (<= 25 mm)
6.Women with current cerclage
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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 <br/ ><br>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 <br/ ><br>Timepoint: At least 15 days after using the progesterone formulations and later whenever the women complain