Comparison of Dydrogesterone Alone Versus Dydrogesterone Plus HCG in Threatened Miscarriage (DYD-HCG)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Islamabad、Punjab Province、パキスタン、44000
- Pakistan Air Force Hospital, Islamabad
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
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実験的：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.
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Dydrogesterone 10 mg administered orally twice daily for the treatment of threatened miscarriage during first trimester pregnancy.
Human chorionic gonadotrophin 5000 IU administered intramuscularly once weekly until 14 weeks of gestation as adjunct therapy with Dydrogesterone.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants with Treatment Success as Assessed by Absence of Vaginal Bleeding and Visual Analogue Scale (VAS) Score
時間枠：14 days after initiation of treatment
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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.
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14 days after initiation of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Achieving Treatment Success in Each Treatment Group
時間枠：14 days after initiation of treatment
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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).
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14 days after initiation of treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Visual Analogue Scale (VAS) Pain Score and Vaginal Bleeding Pattern
時間枠：14 days after treatment initiation
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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.
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14 days after treatment initiation
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PAF-OBS-RCT-2025-26-01
- ERC/FPGMI/ /49/2025 (その他の識別子：FAZAIA POST GRADUATE MEDICAL INSTITUTE, ISLAMABAD, ETHICAL REVIEW COMMITTEE)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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