Efficacy of mifepristone as compared to oral progestin therapy in management of acute abnormal uterine bleeding: a randomised pilot study

Topic Efficacy of mifepristone compared to oral progestin therapy in management of acute aub

This study is designed as a randomized controlled pilot trial to be conducted in the Department of Obstetrics and Gynaecology, AIIMS New Delhi. The participants will include non-pregnant women of reproductive age presenting with acute abnormal uterine bleeding . Eligible women will be  screened based on inclusion and exclusion criteria, and those consenting will be  randomized using a computerized table with concealed allocation. A total of 110 subjects will be recruited and will be divided equally into two groups.

Group 1 will  receive oral mifepristone 50 mg twice daily for five days or until cessation of bleeding  while Group 2 will receive oral medroxyprogesterone acetate 20 mg thrice daily for five days followed by 10 mg twice daily for 21 days. Tranexamic acid 500 mg  8 hourly will be administered additionally in either group if required. All participants shall receive oral iron supplementation.

The primary outcome will be  measured in terms of the number of women achieving cessation of bleeding within five days of initiating treatment. Secondary outcomes will include time taken for cessation of bleeding reduction in blood loss assessed by PBAC scores comparative efficacy of mifepristone versus progestins across different etiologies requirement of additional tranexamic acid, and patient satisfaction.

Participants will undergo baseline investigations and follow-up including clinical and laboratory evaluation. Response to treatment will be  assessed after two weeks either in person or telephonically with PBAC scoring used for quantification. All women will be  further evaluated to determine the underlying cause of AUB and will be  provided with definitive management along with treatment for iron deficiency or anemia where indicated.