A Prospective, Randomized, Open Label, Phase III, Multicentric ClinicalTrial To Compare The Efficacy And Safety Of Monoclonal Anti Rho (D)Immunoglobulin With Polyclonal Anti Rho (D) Immunoglobulin InPrevention of Hemolytic Disease Of Newborn.

Bharat Serums Vaccines Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

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 (If already randomized, such patients will be withdrawn from the study)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

发起方

Bharat Serums Vaccines Limited