A study to assess clinical use and safety of once daily natural progesterone in threatened miscarriage cases

dRug Utilization Surveillance study of natural progeSterone SR in Threatened miscarriage: with Luteal phase insufficiency: RUSST analyses - RUSST

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/05/013901

Enrollment

250

Registered

2018-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O098- Supervision of other high risk pregnancies Health Condition 2: null- Threatened Miscarriage with spotting or premature contractions

Interventions

Intervention1: Dubagest SR (Oral Micronized Progesterone): 300 mg OD till term (upto 34 weeks) Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive Threatened miscarriage cases supplemented with OMP SR that was administered for Active symptoms or as secondary prophylaxis strategy to prevent PTB

Exclusion criteria

Exclusion criteria: Patients with Baseline reference data ALONE will be ruled out from analyses

Design outcomes

Primary

Measure	Time frame
1. Nuchal scan score 2. Î²-hCG levelsTimepoint: Till 34 weeks	—

Secondary

Measure	Time frame
Safety assessment for TEAEs and SAEsTimepoint: Till 34 weeks	—

Countries

India

Contacts

Public ContactDr K Krishnaprasad

Glenmark Pharmaceuticals Ltd.

K.Krishna.Prasad@glenmarkpharma.com9820806811

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026