Clinical Research Directory

Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.

Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.

PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.