Intrauterine System Effective for Those With and Without Inherited HMB

Intrauterine System Effective for Those With and Without Inherited HMB
Research compares outcomes in the two groups using long-acting levonorgestrel-releasing intrauterine systems.

Intrauterine systems (IUS) still suffer from a reputation carried over from past concerns about perforation, pelvic inflammatory disease, or lasting impact on fertility.

These concerns recently have been resolved by a combination of superior devices and the accumulation of data demonstrating good safety profiles, and IUS are emerging as a mainstay of treatment for girls and women with heavy menstrual bleeding.

Additional work is underway to promulgate guidelines for appropriate IUS use and delineate the benefits for patients with and without an inherited blood disorder.

Hematologist Allison P. Wheeler, M.D., runs a women’s bleeding disorder clinic at Vanderbilt University Medical Center with gynecologist Celeste O. Hemingway, M.D., who has a special interest in adolescent health.

Wheeler is also part of the Foundation for Women and Girls with Blood Disorders Learning Action Network, a group that is striving to build an evidence base for optimal treatments for all girls and women, including IUS use. In April, the group published a study in the Journal of Adolescent Health comparing outcomes from a 52mg levonorgestrel-releasing intrauterine system (LNG-IUS) used by females with inherited and non-inherited heavy menstrual bleeding, a novel query. The study also is one of a few to focus more on adolescents than adults.

The outcomes provide more assurance on IUS safety and effectiveness and demonstrate general equivalency between these two groups of patients.

“Historically, the average age at which a woman with heavy menstrual bleeding is diagnosed with a bleeding disorder is 35 years old,” Wheeler said. “We in the medical community think we can do better to improve care for women with bleeding disorders.”

Treating Adolescents with a QOL Focus

Heavy menstrual bleeding is a common complaint among adolescents and is defined by factors enumerated in the Philipp tool, including clot size, presence of anemia, length of the periods and saturation rate of pads or tampons.

“Defining heavy menstrual bleeding has always been difficult. Previously, it has been defined as blood loss of greater than 80 milliliters in a menstrual period, however this has always been difficult to measure. We are now asking the broader question: Is heavy menstrual bleeding disruptive to quality of life for these girls and women?” Wheeler said.  

Upwards of 10 percent of adolescent girls and women with heavy menstrual periods have an inherited bleeding disorder such as von Willebrand disease (most common), or a platelet or clotting disorder such as a hemophilia A carrier. Wheeler says that these are the patients most likely to find themselves in the emergency department requiring blood or iron infusion or in need urgent hormone treatment to stabilize heavy menstrual bleeding.

“We in the medical community think we can do better to improve care for women with bleeding disorders.”

Management options such as hormonal preparations or non-hormonal options require shots or pills taken regularly, which can be challenging for adolescent adherence. The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists both promote the LNG-IUS for management of heavy menstrual bleeding in adolescents to avoid these challenges.

Equivalent Outcomes

Past studies have demonstrated IUS superiority to other treatments in adult women with heavy menstrual bleeding, with or without an inherited bleeding disorder.

However, there have been concerns about higher complications like expulsion and malpositioning in women with blood disorders. This new multi-center retrospective study by Wheeler and colleagues helps respond to these concerns and provides additional insight.

The team recruited 139 patients between 14 and 21 years of age who had undergone a total of 144 insertions of the long-acting LNG-IUS. The group, all of whom experienced heavy menstrual bleeding, included 59 with an inherited bleeding disorder and 85 without a blood disorder.

All patients were evaluated through the first 12 months following insertion. Not unexpectedly, those with an inherited bleeding disorder experienced heavier blood flow. However, more than 90 percent of patients across both groups reported significant symptom improvement. Therefore, contrary to reports from some previous studies, underlying inherited blood disorders did not dampen the beneficial effect of 52-LNG-IUS use.

More adolescent girls with an inherited bleeding disorder experienced IUS expulsion, but the differences did not reach statistical significance, in contrast to some smaller studies showing higher rates in those with inherited bleeding.

“The novel finding of our study, however, is that rates of overall improvement from 52-LNG-IUS use were similar across all subjects with heavy menstrual bleeding, whether or not a diagnosed inherited blood disorder was present,” Wheeler said.

Clinical Approaches to IUS

“There has been a more recent increase in the hematology focus on women with bleeding disorders as we hematologists are working in much closer relationship with our gynecology colleagues,” Wheeler said.

In 2019, Wheeler and colleagues surveyed clinicians who care for adolescents with heavy menstrual bleeding both with and without inherited blood disorders to determine provider attitudes and clinical practices regarding the LNG-IUS.

The consensus among providers was that the progesterone-based IUS was both safe and effective, regardless of whether the patient had a bleeding disorder. However, their approaches to IUS use varied widely in terms of candidacy, insertion settings, sedation and other medications given.

“This really has to be personalized,” Hemingway said. “If the patient has used tampons, for example, an office placement is usually a very good option. However, we have patients that are better suited for sedated placement in the operating room, and we can accommodate that with a quick, same-day procedure.”

Prospective Studies on Deck

Wheeler says prospective studies are needed to more rigorously compare the 52-LNG-IUS’s benefits and complication rates over a longer period of time among those with and without an inherited blood disorder.

“Rates of overall improvement from 52-LNG-IUS use were similar across all subjects with heavy menstrual bleeding, whether or not a diagnosed inherited blood disorder was present.”

“We plan to address the gaps in the literature with a prospective study and the development of an IUS registry of adolescents with inherited bleeding disorders,” Wheeler said.

In the meantime, she and Hemingway will continue to educate girls and women and their families on their IUS options. “Once you start telling people they don’t have to have horrible periods, it’s really lovely to see the relief,” she said.