CTRI/2024/02/063174尚未招募Unknown
An Open-Label, Randomized Controlled Trial to Compare the Efficacy and Safety of Oral Dydrogesterone Versus Oral Micronized Progesterone in Treating Threatened Miscarriage and in Modulation of Immune Factors - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Pregnant women aged 20 to 39 years with threatened miscarriage (vaginal bleeding and or abdominal pain)in the first trimester
- •2. Gestational age between 5 to 12 weeks
- •3. Euthyroidism or controlled hypothyroidism(based on medical history)
- •4. Presence of a viable pregnancy
- •5. Presence of intrauterine gestational sac on ultrasonography if a urine pregnancy test is first positive within the past 2 weeks
- •6. BMI between 18 and 30 kg per m2
- •7. Willingness to provide written informed consent
排除标准
- •1. Pregnant women with inevitable abortion
- •2. History of recurrent miscarriage defined as at least two consecutive spontaneous miscarriages
- •3. Heavy vaginal bleeding or severe abdominal pain requiring surgical intervention
- •4. Presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat, or a mean
- •gestational sac of greater than equal to 25mm with no viable fetal pole in ultrasound
- •5. Evidence of ectopic pregnancy
- •6. Conceived on gonadotrophins or with the use of assisted reproductive technologies
- •7. Abnormalities in the structure of the uterus or amputation of the cervix, or any other genital tract anomalies
- •8. Uterine myoma with submucosal location of the node(a clinically significant size as judged by the Investigator)
- •9. Anembrion or fetal malformations as established causes of loss of previous pregnancies
- •10. Other clinically significant causes of miscarriage identified during
- •examination (including but not limited to pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, or psychiatric illnesses)
- •11. Known Sexually Transmitted Diseases (STDs)
- •12. Administration of enzyme-inducing medicinal products such as (anticonvulsants, antipsychotics, antidepressants, tranquilizers), use
- •of psychoactive substances before and during pregnancy
- •13. Multiple pregnancy
- •14. Known as having an endocervical polyp
- •15. Known as having infection such as pneumonia, pyelonephritis, septicemia
- •16. Known as having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
- •17. Known as having a coagulation defect
- •18. Known as having severe heart, liver, lung, kidney, or other organ disorder
- •19. Current or ongoing substance abuse, including alcohol and tobacco, as determined by the Investigator
- •20. History of chemotherapy or radiotherapy
- •21. Known allergy or hypersensitivity to dydrogesterone or oral micronized progesterone
- •22. Use of hCG or dydrogesterone or progesterone within 1 month prior to study enrollment
- •23. Participation in any other clinical trial within 30 days prior to the study enrollment
- •24. Planned participation in any other trial during the entire duration of the study
- •25. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic or hospital visits and
- •laboratory tests
- •26. Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
- •27. Any other clinical condition(s) that, as judged by the Investigator, contradict(s) inclusion criteria, may lead to early termination of the subject participation in the study, or make it difficult to interpret the results obtained in the study
研究者
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