Health Condition 1: Z349- Encounter for supervision of normal pregnancy, unspecified
Conditions
Interventions
Intervention1: Dydrogesterone Sustained Release (SR) Tablet: Dosage: 20mg,
Dose: OD,
Duration: Participants will be observed from enrolment (4-8 weeks gestation) until 12 weeks gestation,
Mode of Admi
Sponsors
Dr Mehul Sukhadiya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female, age 18 - 40 years, willing to provide written Participant Authorization Consent Form for data collection. 2. Confirmed intrauterine pregnancy by ultrasound (gestational sac) with gestational age of about 4 to 8 weeks at enrolment. 3. Treated in routine practice for early pregnancy support, under one o the following routine care clinical scenarios: Threatened miscarriage: vaginal bleeding with or without abdominal pain/cramping with viable intrauterine pregnancy (fetal cardiac activity present), OR Luteal/early pregnancy support as per Gynaecologist judgement (e.g., history of prior loss, low progesterone suspected/recorded, etc.). 4. The treating Gynaecologists has already prescribed either: Dydrogesterone CR regimen (as per routine practice), or Dydrogesterone SR regimen (as per routine practice), before or at the enrolment visit, and the study does not influence treatment choice. 5. Ability to comply with follow up (clinic) till 12 weeks gestation (or pregnancy outcome, whichever earlier).
Exclusion criteria
Exclusion criteria: 1. Ectopic pregnancy, pregnancy of unknown location, or molar pregnancy. 2. Non-viable pregnancy at baseline (e.g., no fetal cardiac activity when expected, anembryonic pregnancy) as per clinician judgement/ultrasound. 3. Planned elective termination at enrolment. 4. Confounding therapy / medical exclusions. 5. Use of Dydrogesterone or Progesterone or hCG within 30 days prior to enrolment/baseline 6. Use of medications known to materially affect pregnancy outcome in early gestation unless clinically essential and stable. 7. Significant uncontrolled medical illness that, in Investigator s opinion, independently increases miscarriage risk and would confound outcomes (e.g., uncontrolled diabetes, uncontrolled thyroid disease, severe systemic autoimmune flare, etc.). 8. Known major uterine anomaly strongly linked to miscarriage (e.g., large submucosal fibroid distorting cavity) if Investigator feels it is the dominant cause. 9. Inability/unwillingness to provide participant Authorization consent form for data collection or insufficient baseline data to ascertain gestational age and pregnancy viability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing viable pregnancy at 12 weeks gestation (confirmed clinically and/or by ultrasound) ultrasound), OR Incidence of miscarriage up to 12 weeks gestation. Timepoint: Week 12 of gestation age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to cessation of vaginal bleeding (if present at baseline) Proportion with symptom resolution by Day 14 Need for rescue progesterone therapy Maternal adverse events Treatment adherence & discontinuation rates. Timepoint: Week 12 of gestation age. | — |
Countries
India
Contacts
Public ContactDr Gunjan Shah
Radhe Endoscopy Centre & Infertility Hospital Pvt. Ltd.
Outcome results
None listed