R-Anti-D immunoglobulin to prevent Rh-D sensitisation of Rh-negative pregnant women

A prospective, randomised clinical trial to confirm safety and efficacy of recombinant anti-D immunoglobulin in prevention of isoimmunisation in comparison with polyclonal anti-D immunoglobulin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008101

Enrollment

210

Registered

2017-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O360- Maternal care for rhesus isoimmunization

Interventions

Intervention1: Recombinant anti-D: recombinant IgG antibody 300 mcg postnatally once within 72 hours of delivery Intramuscular route of administration Control Intervention1: Polyclonal anti-D immuno

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Rh D positive or Rh D negative sensitised 2. Rh D negative women delivering Rh D negative infants. 3 Patients who are HIV positive 4. Rh D negative patients with Rh D negative husband.

Design outcomes

Primary

Measure	Time frame
Incidence of RhD sensitisation at the end of the studyTimepoint: Incidence of RhD sensitisation at the end of the study	—

Secondary

Measure	Time frame
Adverse events Immunogenicity sample collection negativeTimepoint: Day 0, post Delivery up to 72 hour, after 72 hour of r-anti-D. Day 30, 90 and 180	—

Countries

India

Contacts

Public ContactGanesh Divekar

Bharat serums and Vaccines ltd.

ganesh.divekar@bharatserums.com022-45043456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026