A randomized controlled trial comparing the efficacy of oral progestogens in the management of threatened miscarriage
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Oral natural micronized progesterone sustained release is non inferior to
Study Overview
Brief Summary
Threatened miscarriage is a fairly common complication in early
pregnancy. Various studies have claimed the role of progesterone in management of threatened abortion. An oral sustained-release formulation of NMP (NMP-SR) has been developed which has a better tolerability profile and bioavailability than conventional oral NMP allowing for once-daily dosing. Also dydrogesterone allows
administration of lower dose and avoids progestogenic side effects. Based on these evidences we will take an attempt to compare the efficacy of the two preparations of progesterone in patients with threatened miscarriage.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Period of gestation between 6-16 weeks presenting with threatened miscarriage (with or without the history of 1/more abortion of unknown etiology) confirmed by dating scan.
- •Confirmed intra uterine live pregnancy (by means of ultrasonography).
Exclusion Criteria
- •Age of women older than 40 years, IVF pregnancy Multifoetal pregnancy Pregnancy with any condition that can explain her present miscarriage.
Outcomes
Primary Outcomes
Oral natural micronized progesterone sustained release is non inferior to
Time Frame: Till 28 weeks of gestation or the time of delivery (whether complete abortion or live birth)
dydrogesterone in the management of threatened miscarriage in 121 antenatal patients
Time Frame: Till 28 weeks of gestation or the time of delivery (whether complete abortion or live birth)
Secondary Outcomes
- To assess the efficacy of oral progestogens in threatened miscarriage.(From 28 weeks of period of gestation or upto the period of gestation at the time of delivery whether live birth or abortion)