Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage

NCT07608133 | Completed DMC

• 2 other identifiers: PAF-OBS-RCT-2025-26-01ERC/FPGMI/ /49/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dydrogesterone; HCG; First trimester bleeding; Randomized controlled trial; Pregnancy outcome; Progesterone therapy

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Proportion of Participants Achieving Treatment Success in Each Treatment Group

  14 days after initiation of treatment

Other Outcomes (1)

• Change in Visual Analogue Scale (VAS) Pain Score and Vaginal Bleeding Pattern

  14 days after treatment initiation

Study Arms (2)

Dydrogesterone Alone Group

EXPERIMENTAL

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 + HCG Group

EXPERIMENTAL

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; Drug: Human chorionic gonadotrophin (hCG)

Interventions

Dydrogesterone DRUG

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

Dydrogesterone + HCG Group; Dydrogesterone Alone Group

Human chorionic gonadotrophin (hCG) DRUG

Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone.

Dydrogesterone + HCG Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

Pakistan Air Force Hospital, Islamabad

Islamabad, Punjab Province, 44000, Pakistan

Location

Related Publications (2)

• Devall AJ, Papadopoulou A, Podesek M, Haas DM, Price MJ, Coomarasamy A, Gallos ID. Progestogens for preventing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD013792. doi: 10.1002/14651858.CD013792.pub2.

  PMID: 33872382 BACKGROUND

• Haas DM, Hathaway TJ, Ramsey PS. Progestogen use for prevention of miscarriage: updated systematic review and meta-analysis. Obstetrics & Gynecology. 2021;137(3):503-512.

  BACKGROUND

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Dydrogesterone; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding will be applied in this study. Both participants and investigators will be aware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned into two parallel groups. Group A will receive Dydrogesterone alone, while Group B will receive Dydrogesterone combined with human chorionic gonadotrophin (HCG). Both groups will be followed and compared for treatment efficacy.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 27, 2026
• Study Start: December 9, 2025
• Primary Completion: April 20, 2026
• Study Completion: May 15, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

PA (1)