Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization R… (NCT01666249) | Clinical Trial Compass
SuspendedPhase 3
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.
Stopped: Suspended for indetermined period.
Brazil347 participantsStarted 2014-04
Plain-language summary
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Agree to participate, sign and date ICF;
* 18 years old or older;
* Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby.
Exclusion Criteria:
* Be participating simultaneously or have participated in another clinical trial within the last 12 months;
* Mothers who are allergic to any components of the formula;
* Mothers who have a history of IgA deficiency or IgA antibody present;
* Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis;
* Mothers who have indirect Coombs test positive at the beginning of the treatment;
* Rh-negative mothers whose delivered Rh-negative babies;
* Abnormalities of the coagulation system;
* Patients who made use of vaccines made with live pathogens in the last 03 months or will make during the study;
* Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;
* Principal Investigator of the study criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Negative result for coombs test up to six months after immunization