None listed
Conditions
Interventions
None listed
Sponsors
Bharat serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject who has provided the written informed consent form to participate in the study 2) Subject is â?¥ 18 years of age 3) Rh-negative pregnant women
Exclusion criteria
Exclusion criteria: 1) Subject not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Subject demographics (age), anthropometric data (height, weight), vital signs 2) Family status & Rh-positive or Rh-negative status of husband and/or previous child 3) Previous pregnancy details (LMP, delivery date & type, ICT done or not, Rh sensitization, complications, history of miscarriages) 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) 5) Complications in current pregnancy (hemolytic anemia, kernicterus, icterus gravis neonatorum, hydrops fetalis), delivery type 6) AE related to the use of anti-D and its causal assessment in relation to BSV product(s) Timepoint: 3 months of follow up period after date of enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactAnirban Roy Chowdhury
Bharat Serums and Vaccines Ltd.
Outcome results
None listed