A study to compare the patient reported outcomes with the use of oral dydrogesterone vs. micronized vaginal progesterone in high risk pregnancies
Not Applicable
- Conditions
- Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history
- Registration Number
- CTRI/2022/11/047511
- Lead Sponsor
- Emcure Pharmaceuticals Ltd
- 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 with age of >= 18 years and who are ready to give informed consent for participation in the study.
2.Women with clinically diagnosed pregnancy of <= 12 weeks of gestation and visiting department of obstetrics and gynecology.
3.History of more than two miscarriages and/or presenting with vaginal bleeding
4.Patient suitable for treatment with micronized vaginal progesterone or dydrogesterone therapy based on locally approved prescribing information.
Exclusion Criteria
1.Pregnant women who have contraindications for use of micronized vaginal progesterone or dydrogesterone.
2.Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Patient reported adverse events: <br/ ><br>o Vulvovaginal symptoms reported: vaginal itching, irritation, burning, discharge and others. <br/ ><br>o Other adverse events reported: Nausea, vomiting, abdominal cramps, gastritis, diarrhoea, constipation headache, fatigue, breast pain or tenderness, muscle, joint or bone pain and others. <br/ ><br>2.Patient experience with the study medicationTimepoint: Week 4 and Week 8
- Secondary Outcome Measures
Name Time Method Other measures: Obstetric History, Risk factor(s), Co-prescribed Medication(s)Timepoint: Week 4 and Week 8;Percentage of patients lost to follow upTimepoint: Week 4 and Week 8;Percentage of patients switched to other treatment (other type of progesterone)Timepoint: Week 4 and Week 8;Treatment complianceTimepoint: Week 4 and Week 8;Utilization pattern: Dose prescribed, Dosing frequency, Duration of treatmentTimepoint: Week 4 and Week 8