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Safety and Use of Dydrogesterone in Women with Repeated Miscarriages or Pregnancy Complications

A cross-sectional analysis to assess the safety and Utilization of dydrogesterone in Patients with bad obstetRIc hiStory or habitual abortion in rEal world outpatients of India - UPRISE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068990
Enrollment
2000
Registered
2024-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Torrent Pharmaceuticals Ltd
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 (fetal viability confirmed with ultrasound)Timepoint: At 12 weeks—

Secondary

MeasureTime frame
Patient acceptability to treatmentTimepoint: At 4 weeks;Safety assessment for Common Adverse eventsTimepoint: At 4 weeks—

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Ayuh Fertility Centre

ayuhfertilitycentre@gmail.com7948983895

Outcome results

None listed

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