Health Condition 1: null- Women with recurrent pregnancy loss
Conditions
Interventions
Intervention1: Dydrogestrone: 10 mg BD till 20 weeks of pregnancy
Control Intervention1: Placebo: 10 mg BD till 20 weeks of pregnancy
Sponsors
Indian Council of Medical Research
Maulana Azad Medical College New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age group 18-35 years. 2. Women with history of at least three first trimester pregnancy loss and no history of successful pregnancy. 3. Women enrolled in first trimester preferably at 4-6 weeks of gestation. The pregnancy confirmation is done by estimating serum levels of beta hCG.
Exclusion criteria
Exclusion criteria: 1. Women with 1 or 2 spontaneous abortions. 2. Women with known cause of RPL evaluated as per hospital protocol (anatomical, hormonal, chromosomal, autoimmune or infection). 3. Women who have taken Inj. hCG, proluton etc. during index pregnancy.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome:- To find out how many pregnancies continued beyond 20 weeks of gestation and their pregnancy outcome and its correlation with cytokine levels and dydrogesterone administration.Timepoint: Three Years | — |
Primary
| Measure | Time frame |
|---|---|
| a) To observe the cytokine levels of women with history of RPL and healthy pregnant control at the time of enrollment and the end of study and to compare the variation in their levels. b)To observe whether the administration of dydrogesterone causes any change in titers of Th1 (IFN-gamma, TNF-α) and Th2 (IL-4, IL-10) cytokines.Timepoint: Three years | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar
University of Delhi
Outcome results
None listed