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

24. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Dydrogesterone
Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Eksperimentell: 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.
Legemiddel: Dydrogesterone
Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Legemiddel: Human chorionic gonadotrophin (hCG)
Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Achieving Treatment Success in Each Treatment Group
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Visual Analogue Scale (VAS) Pain Score and Vaginal Bleeding Pattern
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. desember 2025

Primær fullføring (Faktiske)

20. april 2026

Studiet fullført (Faktiske)

15. mai 2026

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

24. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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