postpartum women with blood type negative Rh and indirect coombs test negative, whose newborn is positive Rh
Conditions
Interventions
Study multicenter, prospective and non-comparative. They will be selected 232 female participants, puerperae with a negative Rh factor. The participants will receive a single dose of the drug (anti-Rh
Biological/vaccine
Sponsors
Hospital São Lucas da PUC/RS (Centro Coordenador)
LAL Clinica Pesquisa e Desenvolvimento Ltda.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Postpartum women who agreed to participate and sign and date back to the Informed Consent (IC); Postpartum women over the age of 18; negative Rh postpartum women, Coombs negative indirect analyzed by gel agglutination method, whose newborn is Rh +.
Exclusion criteria
Exclusion criteria: Simultaneously be participating or have participated in another clinical study within the last 12 months; postpartum women allergy sufferers to any of the components of the formula; postpartum women with IgA deficiency history or story to IgA antibody; postpartum women with a history of autoimmune hemolytic anemia with pre-existing risk with hemolysis or hemolysis; postpartum women who have positive Indirect Coombs test at the beginning of treatment; postpartum women who have given birth to negative Rh fetuses; postpartum women with abnormalities of the coagulation system; Patients who used elaborate vaccines with live pathogens in the last 03 months or will do during the study; Patients with pre-natal clinical diagnosis of liver disease and / or severe nephropathy. At the discretion of the Principal Investigator of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is hoped that the study drug (anti-Rh D human immunoglobulin) is effective in maintaining the negative result for the consideration of indirect Coombs, 06 months after birth, measured by the indirect Coombs test. The indirect Coombs test uses the agglutination gel method due to its higher sensitivity than the conventional method of agglutination plate. Product efficacy will be assessed by the prevalence of the disease in the study, compared to the data available in the literature (bi-nominal testing) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is hoped that the study drug is safe for administration to women in the postpartum period. The safety of the drug will be evaluated through quantitative and qualitative parameters (type, frequency and intensity) related adverse events presented by the patients during the study, obtained through clinical, laboratory tests and reports of the participants. The data obtained at the end of the survey will be analyzed and presented to statistical study | — |
Countries
Brazil
Contacts
Public ContactJoão Hazbun
Panamerican Medical Supply Suprimentos Médicos Ltda.
Outcome results
None listed