Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage (DYD-HCG)

May 24, 2026 updated by: Sara Ashfaque, Pakistan Air Force (PAF) Hospital Islamabad

Comparison of Dydrogesterone Alone With Dydrogesterone Plus Human Chorionic Gonadotrophin (HCG) in the Treatment of Threatened Miscarriage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Threatened miscarriage is a common complication in early pregnancy, affecting a significant proportion of women in the first trimester. It is clinically defined by vaginal bleeding with or without abdominal pain while the cervical os remains closed. Although many pregnancies with early bleeding continue successfully, a considerable proportion may progress to miscarriage, making early and effective management essential.

Progesterone plays a key role in the maintenance of pregnancy by supporting endometrial stability and preventing uterine contractions. Dydrogesterone, a synthetic progesterone, is widely used for the management of threatened miscarriage. However, clinical outcomes remain variable, and additional therapeutic strategies are being explored.

Human chorionic gonadotrophin (HCG) is a glycoprotein hormone produced by the syncytiotrophoblast early in pregnancy. It supports corpus luteum function and progesterone production and may also have direct effects on uterine blood flow, angiogenesis, and endometrial receptivity. These mechanisms suggest a potential benefit of combining HCG with progesterone therapy.

This randomized controlled trial will be conducted in the Department of Obstetrics and Gynecology, PAF Hospital Islamabad after approval from the ethical review committee. A total of 100 women diagnosed with threatened miscarriage in the first trimester will be enrolled through consecutive non-probability sampling and randomly assigned into two equal groups.

Group A will receive oral Dydrogesterone 10 mg twice daily, while Group B will receive the same dose of Dydrogesterone along with intramuscular HCG 5000 IU weekly until 14 weeks of gestation.

Participants will be followed for 14 days after initiation of treatment. The primary outcome measure is treatment efficacy, defined as absence of vaginal bleeding and pain score ≤4 on Visual Analogue Scale (VAS). Secondary analysis will include comparison of efficacy between both groups using chi-square test, with p-value <0.05 considered statistically significant.

Data will be analyzed using SPSS version 24. Results of this study will provide evidence regarding the comparative effectiveness of combination therapy versus progesterone alone in the management of threatened miscarriage and may contribute to improved clinical guidelines in local population settings.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Islamabad, Punjab Province, Pakistan, 44000
        • Pakistan Air Force Hospital, Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dydrogesterone Alone Group
Participants in this arm will receive oral Dydrogesterone 10 mg twice daily as monotherapy for the treatment of threatened miscarriage in the first trimester. The intervention will be continued as per study protocol until assessment of treatment efficacy at day 14. This group will serve as the comparator for evaluating the effect of Dydrogesterone alone.
Drug: Dydrogesterone
Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Experimental: Dydrogesterone + HCG Group
Participants in this arm will receive oral Dydrogesterone 10 mg twice daily in combination with intramuscular human chorionic gonadotrophin (HCG) 5000 IU weekly until 14 weeks of gestation. This combination therapy is being evaluated for its additional benefit over Dydrogesterone alone in the management of threatened miscarriage. Treatment efficacy will be assessed at day 14 based on clinical improvement.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Success as Assessed by Absence of Vaginal Bleeding and Visual Analogue Scale (VAS) Score
Time Frame: 14 days after initiation of treatment
Treatment success is defined as the absence of vaginal bleeding AND a pain score ≤4 on the Visual Analogue Scale (VAS) after 14 days of treatment in women with threatened miscarriage. The VAS is a continuous scale ranging from 0 (no pain) to 10 (worst possible pain), where lower scores indicate less pain and a better outcome.
14 days after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Treatment Success in Each Treatment Group
Time Frame: 14 days after initiation of treatment
To compare the proportion of patients achieving treatment success between Dydrogesterone alone and Dydrogesterone plus human chorionic gonadotrophin (HCG) groups in threatened miscarriage. Treatment success is defined as absence of vaginal bleeding and Visual Analogue Scale (VAS) score ≤4 (scale: 0-10, where 0 = no pain and 10 = worst possible pain; lower scores indicate better outcome).
14 days after initiation of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS) Pain Score and Vaginal Bleeding Pattern
Time Frame: 14 days after treatment initiation
To assess change in abdominal pain and vaginal bleeding patterns in both study groups during the follow-up period. Pain will be assessed using the Visual Analogue Scale (VAS), a continuous scale from 0 (no pain) to 10 (worst possible pain), where lower scores indicate less pain and a better outcome. Vaginal bleeding will be assessed as present/absent and by bleeding pattern (spotting, light, moderate, heavy). Data will be reported as change from baseline to Day 14.
14 days after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Actual)

April 20, 2026

Study Completion (Actual)

May 15, 2026

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAF-OBS-RCT-2025-26-01
  • ERC/FPGMI/ /49/2025 (Other Identifier: FAZAIA POST GRADUATE MEDICAL INSTITUTE, ISLAMABAD, ETHICAL REVIEW COMMITTEE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data (IPD) is currently undecided. Data sharing decisions will be made after completion of the study, taking into account institutional policies, ethical committee guidelines, and publication requirements. Any future data sharing will ensure participant confidentiality and compliance with relevant regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Pregnancy Bleeding

Clinical Trials on Dydrogesterone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe