IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Screening: All potential participants will be screened. Screening may take place via a phone call if possible. Menstrual history will be reviewed to ensure potential participants meet study definition of heavy menstrual bleeding (self-described bothersome heavy periods, or >7 bleeding days per month). If the participant is a current or former patient in the Jefferson system, the electronic medical record (EMR) will be reviewed as part of screening. If records are available in the EMR that allow confirmation of anemia via the criteria below, screening may be considered complete, and the potential participant may move to an enrollment visit. If the potential participant does not have any records available to review to confirm anemia, they will be seen for an in-person screening visit. If patient has had evaluation as described immediately below completed elsewhere, that is not accessible in the Jefferson EMR or Care Everywhere system, participant will be asked to provide those records for review, and will be seen for an in-person screening visit.

Records will be reviewed to determine if patient has a recently documented diagnosis of anemia. Records will be reviewed to determine if there has been an appropriate clinical evaluation of AUB, generally considered a pelvic ultrasound within the last 12 months and possibly endometrial biopsy within the last 12 months. Standard clinical criteria will be applied to consider whether an endometrial biopsy is needed to rule out malignancy or hyperplasia prior to enrollment. An endometrial biopsy within 12 months will be required for all women over age 40 who have >7 bleeding days per month. An endometrial biopsy will be required for women under age 40 who have >7 bleeding days per month who have at least one additional risk factor for endometrial hyperplasia: obesity with BMI>30, use of any hormone therapy other than standard contraceptive formulations, reported history of polycystic ovarian syndrome, family history of gynecologic or colon cancers in a first degree relative.

If patient has known anemia (hgb <11.5 documented within 60 days) and is not on any current corrective iron therapy and has had appropriate clinical evaluation, participant will move to the enrollment phase.

If patient does not meet above criteria, further evaluation will be done to ensure enrollment criteria. Any patient who needs any evaluation that involves a procedure as described below, will undergo informed consent for the study at this time.

This evaluation will be targeted to address what is lacking in screening: