Health Condition 1: O039- Complete or unspecified spontaneous abortion without complication
Conditions
Interventions
Intervention1: Oral dydrogesterone: Oral dydrogesterone (40 mg STAT, followed by 10 mg TID)
till a maximum of 14 weeks of gestation
Control Intervention1: Oral micronized progesterone: Oral micronized
Sponsors
Mankind Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Miscarriage rate before 20 weeks of gestationTimepoint: Week5, Week6, Week8, Week10, Week12, Week14 and Week 18-20 ( Weeks of gestation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints 1. Ongoing pregnancy rate at 24 weeks 2. Change in serum levels of cytokines(IL-4, IL-10, IFN-Ã?³, & TNF-Ã?±) from baseline to end of treatment 3. Time to symptom (vaginal bleeding or abdominal pain) resolution Safety Endpoints 4.Treatment-Emergent Adverse Events(TEAEs) 5. Changes in Complete Blood Count(CBC) 6. Change in results of Liver Function Tests (LFT) from baseline to 14 & 24-26 weeks of gestation 7. Change in results of Kidney Function Tests (KFT) from baseline to 14 & 24-26 weeks of gestation Exploratory Endpoints 8. Rate of live birth 9. Mode of delivery 10. Gestational age & birth weight of newborn 11. Resuscitation requirements 12. Congenital anomalies in the newborn 13. History of pre-eclampsiaTimepoint: Secondary Endpoints 1. Week5,6,8,10,12,14,18-20 & 24-26 2. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery 3. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery Safety Endpoints 1. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery 2. Week5,6,8,10,12,14,18-20 & 24-26 3. Week5-12,14,24-26 4. Week5-12,14,24-26 Exploratory Endpoints 1. Post Delivery 2. Post Delivery 3. Post Delivery 4. Post Delivery 5. Post Delivery 6. Post Delivery | — |
Countries
India
Contacts
Public ContactDr Alka Kriplani
Paras Hospitals
Outcome results
None listed