Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history
Conditions
Interventions
Intervention1: Dydrogesterone Extended-Release tablets (Dydrogest-ER 20): One tablet to be consumed orally, once daily along with water.
Consumption of tablet until the 20th gestational week.
Contro
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pregnant woman aged 20 to 39 years (both inclusive at the time of screening). 2) Participants with unexplained recurrent miscarriages (based on a documented history of 2 or more spontaneous, consecutive miscarriages before 20 weeks gestation) with same partner. 3) Spontaneous conception (as confirmed by serum pregnancy test). 4) Presence of a viable pregnancy with gestational age of 5 to 8 weeks at the time of screening. 5) Positive urine pregnancy test within 2 weeks prior to screening (based on participantâ??s confirmation). 6) Body mass index (BMI) in the range of 18.5 to 29.9 kg/m2 (both inclusive). 7) Participants who are literate and with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 8) Participants who are willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Participants with known hypersensitivity to dydrogesterone. 2) Participants who may have structural uterine anomalies like septate uterus, bicornuate uterus, fibroid, Ashermanâ??s syndrome as assessed by Ultrasonography. 3) Participants with vaginal bleeding or severe abdominal pain requiring surgical intervention. 4) Participants with other clinically significant causes of miscarriage (endocrine disorders) identified during examination (including but not limited to pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, PCOS, hyperprolactinemia). 5) Participants with evidence of clinically relevant cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunologic, dermatologic, connective tissue, Musculo-skeletal, neurologic, psychiatric disorders, major surgery or other relevant disease as revealed by history, physical examination and/or laboratory assessments which might limit participation in, or completion of, the study. 6) Participants with presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat. 7) Participants with evidence of ectopic pregnancy 8) Participants with evidence of multiple pregnancy. 9) Participants with anembryonic pregnancy or fetal malformations as established causes of loss of previous pregnancies - conceived on gonadotrophins or with the use of assisted reproductive technologies. 10) Participants with uterine myoma with submucosal location of the node (a clinically significant size as judged by the Investigator). 11) Participants with known or suspected progesterone dependent neoplasms 12) Participants with Sexually Transmitted Diseases (STDs) 13) Participants with an endocervical polyp. 14) Participants with autoimmune diseases such as but not limited to systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis. 15) Participants with coagulation disorder. 16) Participants with history of chemotherapy or radiotherapy. 17) Use of dydrogesterone or progesterone or hCG within 30 days prior to screening. 18) Participants with current or ongoing substance abuse, including alcohol and tobacco. 19) Participants with suspected inability or unwillingness to comply with the study procedures. 20) Participation in any other clinical trial within 30 days prior to screening. 21) Planned participation in any other trial during the entire duration of the study. 22) Participant with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing participantâ??s safety and her inability to understand and comply with the requirements of the surveillance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with ongoing pregnancy at 20 weeksTimepoint: Visit 02 {Week 5 to 8 of gestation} up to end of study i.e., Visit 04 {Week 20 of gestation} | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with ongoing pregnancy at 12 weeksTimepoint: Visit 02 {Week 5 to 8 of gestation} up to Visit 03 {Week 12 of gestation};Miscarriage rateTimepoint: Visit 02 {Week 5 to 8 of gestation} up to end of study i.e., Visit 04 {Week 20 of gestation};Monitoring adverse events (AEs) and Serious adverse events (SAEs)Timepoint: Throughout the study duration;Monitoring vital signs and conducting physical examinationTimepoint: At each study visit;Monitoring change in Hematological parameters, Routine Biochemical parameters and Routine UrinalysisTimepoint: Screening Visit (Visit 01) and Visit 04 (Week 20 of gestation) | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cliantha Research
Outcome results
None listed