CompletedNot Applicable

Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage

Pakistan100 participantsStarted 2025-12-09

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with singleton pregnancy diagnosed as threatened miscarriage in the first trimester * Age 18 to 40 years * Presence of vaginal bleeding with or without abdominal pain and closed cervical os * Viable pregnancy confirmed on ultrasound (fetal cardiac activity present) * Willing to provide written informed consent Exclusion Criteria: * History of oxytocin or prostaglandin use during current pregnancy * History of abdominal trauma during pregnancy * Septic abortion or signs of infection * Hemodynamically unstable patients * Known bleeding disorders * Known uterine anomalies * Failed or inevitable miscarriage at presentation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Treatment Success as Assessed by Absence of Vaginal Bleeding and Visual Analogue Scale (VAS) Score

Timeframe: 14 days after initiation of treatment

Trial details

NCT IDNCT07608133

SponsorPakistan Air Force (PAF) Hospital Islamabad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

View on ClinicalTrials.gov More Threatened Miscarriage trials