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Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage

NCT07608133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • Threatened Miscarriage
  • Early Pregnancy Bleeding

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.

Sponsors & Collaborators

  • Pakistan Air Force (PAF) Hospital Islamabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-04-20
Completion
2026-05-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608133 on ClinicalTrials.gov