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COMPLETED
NCT07608133
NA

Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage

Sponsor: Pakistan Air Force (PAF) Hospital Islamabad

View on ClinicalTrials.gov

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

DRUG

Dydrogesterone

Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.

DRUG

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