Clinical Research Directory

Single-Layer Versus Double-Layer Uterine Closure After Primary Cesarean Section

This study compares two surgical techniques for closing the uterus after cesarean section: single-layer versus double-layer closure. The primary objective is to determine which technique results in better uterine scar healing, measured by residual myometrial thickness (RMT) and cesarean scar defect (niche) prevalence at 6 weeks and 6 months postoperatively. BACKGROUND: Cesarean section is one of the most common surgeries worldwide. After fetal delivery, the uterine incision must be closed by suture. Poor scar healing can lead to niche formation, abnormal bleeding, pelvic pain, dyspareunia, and complications in future pregnancies including uterine rupture and placenta accreta. INTERVENTION: Participants are randomized 1:1 to receive either: * Single-layer closure: one continuous non-locking suture through full myometrial thickness * Double-layer closure: two successive extra-mucosal non-locking sutures excluding the decidua ASSESSMENTS: Transvaginal ultrasound at 6 weeks and 6 months measures RMT and niche presence. Standardized symptom questionnaires assess pelvic pain, spotting, dysmenorrhea, and dyspareunia. ELIGIBILITY: Women aged 18-45 years undergoing primary cesarean section with singleton pregnancy at term (gestational age ≥ 37 weeks). ENROLLMENT: 384 participants (192 per group) SETTING: Department of Obstetrics and Gynecology, Hedi Chaker University Hospital, Sfax, Tunisia FOLLOW-UP: 6 months per participant in which the patients attend 2 follow-up visits: First visit 6 weeks after surgery. Second visit at 6 months after surgery .And have a pelvic ultrasound at each visit

Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women

The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: * Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? * Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? Participants will be asked to do the following over the \~3 month enrollment period: * attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month * provide several urine and saliva samples each month * either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment. Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.