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Mayekar RV, Paradkar GV, Bhosale AA, et al. Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial. Obstet Gynecol Sci. 2020;63(3):315-322doi: 10.5468/ogs.2020.63.3.315.
Mayekar, R. V., Paradkar, G. V., Bhosale, A. A., Sachan, R., Beeram, S., Anand, A. R., Mundle, S. R., Trivedi, Y., Md, R., Patole, K. P., Sambarey, P. W., Daftary, G. V., John, J., & Divekar, G. H. (2020). Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial. Obstetrics & gynecology science, 63(3), 315-322. https://doi.org/10.5468/ogs.2020.63.3.315
Mayekar, Rahul Vishwanath, et al. "Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial." Obstetrics & gynecology science vol. 63,3 (2020): 315-322. doi: https://doi.org/10.5468/ogs.2020.63.3.315
Mayekar RV, Paradkar GV, Bhosale AA, Sachan R, Beeram S, Anand AR, Mundle SR, Trivedi Y, Md R, Patole KP, Sambarey PW, Daftary GV, John J, Divekar GH. Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial. Obstet Gynecol Sci. 2020 May;63(3):315-322. doi: 10.5468/ogs.2020.63.3.315. Epub 2020 Apr 21. PMID: 32489976; PMCID: PMC7231934.
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Obstet Gynecol Sci. 2020 May;63(3):315-322. doi: 10.5468/ogs.2020.63.3.315. Epub 2020 Apr 21.

Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial.

Obstetrics & gynecology science

Rahul Vishwanath Mayekar, Gopalkrishna Vinayak Paradkar, Archana Anilkumar Bhosale, Rekha Sachan, Sumalatha Beeram, Ashok Ramachandra Anand, Shuchita Ramesh Mundle, Yamini Trivedi, Rashmi Md, Kiran Pandharinath Patole, Pradip Wamanrao Sambarey, Gautam Vinod Daftary, James John, Ganesh Harishchandra Divekar

Affiliations

  1. Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India.
  2. Department of Obstetrics and Gynaecology, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Thane, India.
  3. Department of Obstetrics and Gynaecology, King George's Medical University, Lucknow, India.
  4. Department of Obstetrics and Gynaecology, Gandhi Medical College and Hospital, Secunderabad, India.
  5. Department of Obstetrics and Gynaecology, Grant Medical College and Sir J.J. Group of Hospitals, Mumbai, India.
  6. Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Nagpur, India.
  7. Department of Obstetrics and Gynaecology, AMC MET Medical College and Sheth LG General Hospital, Ahmedabad, India.
  8. Department of Obstetrics and Gynaecology, Apollo BGS Hospital, Mysore, India.
  9. Department of Obstetrics and Gynaecology, Dr. Vasantrao Pawar Medical College and Research Centre, Nashik, India.
  10. Department of Obstetrics and Gynaecology, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
  11. Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.

PMID: 32489976 PMCID: PMC7231934 DOI: 10.5468/ogs.2020.63.3.315

Abstract

OBJECTIVE: To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.

METHODS: This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.

RESULTS: A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D.

CONCLUSION: The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.

Copyright © 2020 Korean Society of Obstetrics and Gynecology.

Keywords: Newborn hemolytic disease; Recombinant proteins; Rh isoimmunization; Rho(D) immune globulin

Conflict of interest statement

Conflict of Interest: The author Gautam Vinod Daftary is the managing director at Bharat Serums and Vaccines Limited. The authors James John and Ganesh Harishchandra Divekar are full-time paid employe

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