comparison of effect between Oral Dydrogesterone and Oral Micronized Progesterone in treating Threatened Miscarriage
- Conditions
- Health Condition 1: O039- Complete or unspecified spontaneous abortion without complication
- Registration Number
- CTRI/2024/02/063174
- Lead Sponsor
- Mankind Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method