study of drug (rhoclone) on Rh negative blood group mother giving birth to Rh positive blood group baby

Phase 3

Completed

• Conditions: Health Condition 1: O360- Maternal care for rhesus isoimmunizationHealth Condition 2: null- Rh negative pregnant females delivering Rh positive baby.

• Registration Number: CTRI/2015/09/006172
• Lead Sponsor: Bharat Serums Vaccines Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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 (If already randomized, such patients will be withdrawn from the study)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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o sensitization (negative indirect coombâ??s test result)Timepoint: 72 hours, day 90 and day 180 post study drug administration

Secondary Outcome Measures

Name	Time	Method
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