Follow-Up During the Use of the Ointment
bleeding, itching, protectors, pain, vaginal dryness
UTERINE CERVIX, ADVERSE EFFECTS, BLEEDING, ADVERSE EVENTS
The patients were monitored daily from the beginning of the use of the ointment through telephone calls guided by structured questions about possible adverse effects or difficulties in use. In addition, the patients underwent weekly consultations for assessment of the uterine cervix and safety of use. Upon return, all patients presented the applicators used, properly stored in disposable plastic bags, for control and verification of compliance with the prescription. At each consultation, a kit containing an ointment, leaflet, gynecological applicators, daily intimate protectors and plastic bags was distributed. Due to the nature of the intervention, statistics, researchers and patients were blinded to the treatment allocation. Both patient and operator blinding was performed and the control method was using a sealed envelope with specific codes. The codes were kept by a third party, not involved in these processes. Therefore, both the operator and the patient were unaware of the objectives of the study. The adverse events monitored were: bleeding, vaginal dryness, pain in the lower abdomen, burning and itching. All observations were performed by 3 different evaluators, including the return for gynecological evaluation.