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A study to Understand Safety and Benefits of Dydrogesterone Pregnant women

A Case-Cohort, Observational Study to Understand Clinical Safety and Effectiveness of Dydrogesterone In High Risk Pregnancy - D-One Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045715
Enrollment
2500
Registered
2022-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Interventions

None listed

Sponsors

Torrent Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women up to 12 weeks of gestation 2. Women with a history of miscarriage with suspect luteal phase insufficiency 3. Patients willing for follow-up at scheduled visit as per protocol at same center

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or contraindication to study drug 2. Heavy vaginal bleeding requiring surgical intervention. 3. Any uterine anomalies. 4. Any associated medical and surgical illness.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate at 24th weeks (fetal viability confirmed with ultrasound)Timepoint: 24th weeks—

Secondary

MeasureTime frame
Patientâ??s acceptability to treatmentTimepoint: 24th week;Safety assessment for Common Adverse events (1%)Timepoint: 24th week—

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Torrent Pharmaceuticals Limited

KrishnaprasadKorukonda@torrentpharma.com9820806811

Outcome results

None listed

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