R-Anti-D immunoglobulin to prevent Rh-D sensitisation of Rh-negative pregnant wome
Phase 3
Completed
- Conditions
- Health Condition 1: O360- Maternal care for rhesus isoimmunization
- Registration Number
- CTRI/2017/03/008101
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 215
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of RhD sensitisation at the end of the studyTimepoint: Incidence of RhD sensitisation at the end of the study
- Secondary Outcome Measures
Name Time Method Adverse events <br/ ><br>Immunogenicity sample collection negativeTimepoint: Day 0, post Delivery up to 72 hour, after 72 hour of r-anti-D. Day 30, 90 and 180