Comparison of the efficacy of oral progestogens in the management of threatened miscarriage

Phase 3

Completed

• Conditions: Other specified pregnancy relatedconditions,

• Registration Number: CTRI/2023/07/055743
• Lead Sponsor: Dr bidisha banerjee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Study Completion: 2024-11-28
• Last Update Posted: 2024-12-28

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 121

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral natural micronized progesterone sustained release is non inferior to	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	Till 28 weeks of gestation or the time of delivery (whether complete abortion or live birth)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vivekananda institute of medical sciences, Ramakrishna mission seva pratishthan; 🇮🇳 Kolkata, WEST BENGAL, India

Vivekananda institute of medical sciences, Ramakrishna mission seva pratishthan

🇮🇳Kolkata, WEST BENGAL, India

Dr bidisha banerjee

Principal investigator

8250431091

banerjeebids@gmail.com