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

Pakistan Air Force (PAF) Hospital Islamabad

Status: Completed

Conditions: Early Pregnancy Bleeding; Threatened Miscarriage

Treatments: Drug: Dydrogesterone; Drug: Human chorionic gonadotrophin (hCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07608133

PAF-OBS-RCT-2025-26-01

ERC/FPGMI/ /49/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Dydrogesterone Alone Group

Experimental group

Description:

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.

Treatment:

Drug: Dydrogesterone

Dydrogesterone + HCG Group

Experimental group

Description:

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.

Treatment:

Drug: Human chorionic gonadotrophin (hCG)

Drug: Dydrogesterone