A study to Understand Safety and Benefits ofDydrogesterone Pregnant wome
Not Applicable
- Conditions
- Health Condition 1: O098- Supervision of other high risk pregnancies
- Registration Number
- CTRI/2022/09/045715
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate at 24th weeks (fetal viability confirmed with <br/ ><br>ultrasound)Timepoint: 24th weeks
- Secondary Outcome Measures
Name Time Method Patientâ??s acceptability to treatmentTimepoint: 24th week;Safety assessment for Common Adverse events (1%)Timepoint: 24th week