Is RhoGAM (Rho(D) immune globulin) recommended for first trimester vaginal bleeding?

From the Guidelines

RhoGAM (Rho(D) immune globulin) is recommended for Rh-negative women experiencing first trimester vaginal bleeding if there is a risk of fetal-maternal hemorrhage, with a standard dose of 50 mg within 72 hours of the bleeding episode, as indicated by the most recent guidelines 1. The decision to administer RhoGAM depends on the clinical situation and confirmation of the mother's Rh-negative status.

• For threatened abortion with minimal bleeding, some providers may not administer RhoGAM, but for heavier bleeding or confirmed pregnancy loss, it is typically given.
• If Rh status is unknown during an emergency, it's safer to administer RhoGAM until status can be confirmed.
• The preventive approach is important because maternal sensitization could lead to hemolytic disease in future pregnancies with Rh-positive fetuses. The Society for Maternal-Fetal Medicine recommends offering both RhD testing and RhIg administration for spontaneous and induced abortion at less than 12 weeks of gestation in unsensitized, RhD-negative individuals, as the risks associated with RhIg administration are low and the consequences of RhD alloimmunization can be severe 1. In cases where the standard 50 mg dose is not available, a 300 mg dose may be used instead, as recommended by the guidelines 1. It is essential to note that the evidence supporting the administration of RhoGAM in the first trimester is based on the potential risk of fetal-maternal hemorrhage and the consequences of RhD alloimmunization, rather than definitive proof of its necessity in all cases 1.

From the FDA Drug Label

Following threatened abortion at any stage of gestation with continuation of pregnancy, it is recommended that a full dose of HyperRHO S/D Full Dose (1500 IU; 300 mcg) be given. The answer is: Yes, RhoGAM (Rho(D) immune globulin) is recommended for first trimester vaginal bleeding, specifically in the case of a threatened abortion at any stage of gestation with continuation of pregnancy 2.

From the Research

RhoGAM Recommendation for First Trimester Vaginal Bleeding

• The use of RhoGAM (Rho(D) immune globulin) in Rh-negative pregnant women has become standard of care to prevent Rh alloimmunization 3, 4.
• However, the evidence to support the use of Rh immune globulin for a diagnosis of first trimester spontaneous abortion is minimal 5.
• There is significant evidence to demonstrate fetomaternal hemorrhage in first trimester spontaneous abortions, yet no studies demonstrate subsequent maternal sensitization or development of hemolytic disease in the fetus as a result of this hemorrhage 5.
• The practice of administering Rh immune globulin to Rh-negative women with a first trimester spontaneous abortion is based on expert opinion and extrapolation from experience with fetomaternal hemorrhage in late pregnancy, rather than being evidence-based 5.
• Guidelines suggest that Rh immune globulin should be given to all RhD negative women with no anti-D alloantibodies after certain events, including termination of pregnancy, spontaneous abortion, and ectopic pregnancy, but the dose and timing may vary 4.
• In cases of first trimester vaginal bleeding, the dose of Rh immune globulin recommended is typically 50 μg* (before 20 weeks gestation) or 100 μg* (after 20 weeks gestation) 4.
• However, the decision to administer Rh immune globulin for first trimester vaginal bleeding should be made on a case-by-case basis, taking into account the individual patient's risk factors and medical history 5, 6.