Cervix narrowing and stenosis
Conditions
Interventions
Intervention group: 159 postmenopausal women with indication of surgical hysteroscopy will receive cervical preparation with promestriene (vaginal route) in the 4 weeks prior to surgery. In the first
E02.319.452.150
Sponsors
Hospital da Baleia/Fundação Benjamin Guimarães
Hospital da Baleia/Fundação Benjamin Guimarães
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: postmenopausal women; with indication of surgical hysteroscopy; patients of the Hospital da Baleia
Exclusion criteria
Exclusion criteria: Patients who refuse to participate, not signing the consent form; Patients who do not make adequate use of promestriene; Previous attempt at surgical hysteroscopy with complication; Patients with a personal history of breast, ovarian or endometrial cancer; Patients already using hormone therapy; Known hypersensitivity to promestriene or any component of the formulation; Exclusion criteria for the promestriene group: patients with other diseases that contraindicates the use of estrogen (unexplained vaginal bleeding, severe active liver disease, coronary heart disease, stroke, dementia, high risk of venous thromboembolic disease, porphyria cutanea tarda, hypertriglyceridemia and patients with whom there is concern about endometriosis reactivation, possibility of migraine worsening or possibility of leiomyoma growth). These patients will be will be allocated in the placebo group without randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of intraoperative complications in each group (intervention group and placebo group), verified through the review of the participants' operative bulletin. We will see if there is a reduction in the percentage of complications with the use of promestriene | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactIsabela Caetano
Outcome results
None listed