Threatened MiscarriageDYD-HCGNCT07608133
Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage
A study testing Dydrogesterone and Human chorionic gonadotrophin (hCG) in people with Threatened Miscarriage and Early Pregnancy Bleeding, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Threatened Miscarriage, Early Pregnancy Bleeding
- What is being tested?
- Dydrogesterone and Human chorionic gonadotrophin (hCG)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Dec 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Air Force Hospital, Islamabad
Islamabad, Punjab Province, 44000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Threatened Miscarriage, Early Pregnancy Bleeding
- Being tested
- Dydrogesterone, Human chorionic gonadotrophin (hCG)
- Keywords
- Dydrogesterone, HCG, First trimester bleeding, Randomized controlled trial, Pregnancy outcome, Progesterone therapy
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Human chorionic gonadotrophin (hCG)Drug
Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dydrogesterone; Drug: Human chorionic gonadotrophin (hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after initiation of treatment
Secondary outcomes (1)
Proportion of Participants Achieving Treatment Success in Each Treatment Group
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).
Measured: 14 days after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start9 Dec 2025
- Primary completion20 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Threatened MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ashfaque, Pakistan Air Force (PAF) Hospital Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608133
- Sponsor's protocol ID
- PAF-OBS-RCT-2025-26-01
- Other IDs
- ERC/FPGMI/ /49/2025
- Acronym
- DYD-HCG
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 33872382Haas DM, Hathaway TJ, Ramsey PS. Progestogen use for prevention of miscarriage: updated systematic review and meta-analysis. Obstetrics & Gynecology. 2021;137(3):503-512.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dydrogesterone Alone With Dydrogesterone Plus Human Chorionic Gonadotrophin (HCG) in the Treatment of Threatened Miscarriage
- ClinicalTrials.gov ID
- NCT07608133
- Acronym / sponsor ID
- DYD-HCG / PAF-OBS-RCT-2025-26-01
- Conditions
- Threatened Miscarriage, Early Pregnancy Bleeding
- Keywords
- Dydrogesterone, HCG, First trimester bleeding, Randomized controlled trial, Pregnancy outcome, Progesterone therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pakistan Air Force (PAF) Hospital IslamabadUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone Alone Group | Experimental | Drug: DydrogesteroneParticipants 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. |
| Dydrogesterone + HCG Group | Experimental | Drug: Dydrogesterone, Drug: Human chorionic gonadotrophin (hCG)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DydrogesteroneDydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy. | Drug | Dydrogesterone + HCG Group, Dydrogesterone Alone Group |
| Human chorionic gonadotrophin (hCG)Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone. | Drug | Dydrogesterone + HCG Group |
Primary outcome
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.
1 secondary outcome
Proportion of Participants Achieving Treatment Success in Each Treatment Group
Time frame: 14 days after initiation of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 33872382Devall 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.
- BackgroundHaas DM, Hathaway TJ, Ramsey PS. Progestogen use for prevention of miscarriage: updated systematic review and meta-analysis. Obstetrics & Gynecology. 2021;137(3):503-512.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Threatened Miscarriage
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Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dydrogesterone and Human chorionic gonadotrophin (hCG) in people with Threatened Miscarriage and Early Pregnancy Bleeding, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07608133, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.