Health Condition 1: O360- Maternal care for rhesus isoimmunization Health Condition 2: null- Rh negative pregnant females delivering Rh positive baby.
Conditions
Interventions
Intervention1: Monoclonal anti Rho (D) immunoglobulin (Rhoclone®): 300 mcg of Monoclonal anti Rho (D) immunoglobulin (Rhoclone®) will be administered intramuscularly
postnatal within 72 hours of delivery.
Control Intervention1: Polyclonal anti Rho (D) immunoglobulin (RhoGAM®): 300 mcg of Polyclonal anti Rho (D) immunoglobulin (RhoGAM®) will be administered intra
postnatal within 72 hours of delivery.
Sponsors
Bharat Serums Vaccines Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rh negative pregnant non-sensitised (negative indirect Coombs titre) women delivering live Rh positive infant. 2. Patients able to adhere to the study visit schedule and other protocol requirements 3. Subjects willing to participate in the study by giving written informed consent and permission to record the same on a video camera.
Exclusion criteria
Exclusion criteria: 1. Rh negative women with husbands who are Rh negative. 2. Rh D positive or Rh D negative sensitised (positive indirect coombs titre) pregnant women with antibodies to Rh antigen. 3. Rh D negative women delivering Rh D negative infants. 4. Women with history of receiving incompatible blood transfusion. 5. Premature delivery prior to 36 weeks. 6. Women delivering stillborn baby. 7. Patients suffering from any medical condition that in the investigators opinion could compromise the patients ability to participate in the trial. 8. Women participating in another clinical trial in the four weeks before the screening visit. 9. History of anaphylactic or other severe systemic reaction to immunoglobulins. 10. Women with known history of IgA deficiency. 11. Women requiring blood transfusion after delivery. (If already randomized, such patients will be withdrawn from the study) 12. Women with Abruptio placentae, Placenta previa or IUD will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No sensitization (negative indirect coombâ??s test result)Timepoint: 72 hours, day 90 and day 180 post study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of antibodies against Monoclonal Rho Anti-DTimepoint: at screening , post Monoclonal Rho Anti-D administration on day 90 and day 180;Safety assessmentTimepoint: at screening, post study drug administration at 72 hours, day 90 and day 180 | — |
Countries
India
Contacts
Public ContactMs Naju Turakhia
Seth G. S. Medical College & KEM Hospital
Outcome results
None listed