A real-world observational study in Rh-negative pregnant wome
Not Applicable
- Registration Number
- CTRI/2022/01/039101
- Lead Sponsor
- Bharat serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Subject who has provided the written informed consent form to participate in the study
2) Subject is = 18 years of age
3) Rh-negative pregnant women
Exclusion Criteria
1) Subject not willing to participate in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Subject demographics (age), anthropometric data (height, weight), vital signs <br/ ><br>2) Family status & Rh-positive or Rh-negative status of husband and/or previous child <br/ ><br>3) Previous pregnancy details (LMP, delivery date & type, ICT done or not, Rh sensitization, complications, history of miscarriages) <br/ ><br>4) Current pregnancy details (LMP, trimester, details of blood test for Rh-negative, ICT result (if done), sensitization, anti-D use, other pregnancy-related regular medications) <br/ ><br>5) Complications in current pregnancy (hemolytic anemia, kernicterus, icterus gravis neonatorum, hydrops fetalis), delivery type <br/ ><br>6) AE related to the use of anti-D and its causal assessment in relation to BSV product(s) <br/ ><br>Timepoint: 3 months of follow up period after date of enrolment
- Secondary Outcome Measures
Name Time Method ATimepoint: NA