Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
University Women's Hospital
Tübingen, Germany
Spontaneous abortion
Time frame: 6 months
Ectopic pregnancy
Time frame: three years
Vaginal delivery and either
i. Uncomplicated delivery or ii. Delivery with complications such as: * Premature rupture of the membranes (PROM) or * Preterm premature rupture of the membranes (PPROM)
Time frame: three years
Caesarean section delivery and either
i. Uncomplicated delivery or ii. Delivery with complications such as: * Preterm delivery * Preterm labor * Uterine rupture * Stillbirths * Postpartum
Time frame: three years
Procedure-related complications within 1 month post-procedure
Time frame: 1 month
Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie
Time frame: 1 month
Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score
Time frame: three years
Post-treatment changes in myoma size as determined by ultrasound
Time frame: 3, 6, 36 months
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