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Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage
Sponsor: Pakistan Air Force (PAF) Hospital Islamabad
Summary
This randomized controlled trial aims to compare the efficacy of Dydrogesterone alone versus Dydrogesterone combined with human chorionic gonadotrophin (HCG) in the treatment of threatened miscarriage in first trimester pregnancy. Threatened miscarriage is defined as vaginal bleeding with abdominal or pelvic pain in early pregnancy with a closed cervical os. It is one of the most common complications of pregnancy and may lead to pregnancy loss if not managed appropriately. In this study, eligible women aged 18-40 years presenting with threatened miscarriage will be randomly assigned into two groups. Group A will receive oral Dydrogesterone 10 mg twice daily, while Group B will receive oral Dydrogesterone 10 mg twice daily along with intramuscular human chorionic gonadotrophin (HCG) 5000 IU weekly up to 14 weeks of gestation. The primary outcome is treatment efficacy, defined as absence of vaginal bleeding and pain score ≤4 on Visual Analogue Scale (VAS) after 14 days of treatment. The results of this study will help determine whether the addition of HCG to Dydrogesterone provides superior clinical benefit in threatened miscarriage and may guide future treatment protocols.
Official title: Comparison of Dydrogesterone Alone With Dydrogesterone Plus Human Chorionic Gonadotrophin (HCG) in the Treatment of Threatened Miscarriage
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-12-09
Completion Date
2026-05-15
Last Updated
2026-05-27
Healthy Volunteers
No
Interventions
Dydrogesterone
Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Human chorionic gonadotrophin (hCG)
Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone.
Locations (1)
Pakistan Air Force Hospital, Islamabad
Islamabad, Punjab Province, Pakistan