CTRI/2017/03/008101
Completed
Phase 3
A prospective, randomised clinical trial to confirm safety and efficacy of recombinant anti-D immunoglobulin in prevention of isoimmunisation in comparison with polyclonal anti-D immunoglobulin
Bharat Serums and Vaccines Ltd0 sites215 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: O360- Maternal care for rhesus isoimmunization
- Sponsor
- Bharat Serums and Vaccines Ltd
- Enrollment
- 215
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Rh negative pregnant wome delivering Rh positive infants.
- •2\.Patients able to adhere to the study visit schedule .
- •3\.Patients willing to participate in the study
Exclusion Criteria
- •1\.Rh D positive or Rh D negative sensitised
- •2\.Rh D negative women delivering Rh D negative infants.
- •3Patients who are HIV positive
- •4\.Rh D negative patients with Rh D negative husband.
Outcomes
Primary Outcomes
Not specified
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