Comparing the effect of evening primrose oil and misoprostol on cervical preparation before hysteroscopy and dilation and curettage

The aim of this study was to investigate the effect of evening primrose oil with misoprostol on cervical preparation before hysteroscopic and dilation and curettage surgeries.

The clinical trial has a control group, with parallel groups, is double-blind, randomized, and is a phase 2 study that will be done on 100 patients.

Patients in the intervention group will be inserted vaginally in the back of the neck by the interventionist in sessions, 6 hours before the operation. In the control group, under the same conditions, 400 miligrams of misoprostol tablets will be inserted. For this clinical trial, the primary outcome is the dilatation rate and the secondary outcome is the average size of the first uterus. At the time of surgery, the size of the initial Hagar inserted into the internal os and the need to use mechanical dilatation to enter the hysteroscope into the internal os will be recorded by the surgeon.

Inclusion criteria: Women aged 18 to 75 years who were candidates for hysteroscopy and dilation and curettage. Exclusion criteria: Current pregnancy, cervical or vaginal infections, contraindications to misoprostol and EPO, cervical abnormalities and insufficiency, history of Müllerian type birth.

Intervention group: In the group receiving evening primrose oil, 100mg-capsules are placed in the posterior fornix of the vagina, 6 hours before hysteroscopy. Control group: In the group receiving misoprostol, 400 micrograms suppository are placed in the posterior fornix of the vagina 6 hours before hysteroscopy.

Cervical opening preparation

Due to ease of use and saving time, the participants were divided into two groups using random sequence generation software. In this way, information such as the sample size and the number of groups is given to the software (Random allocation software) and the software provides a table of random numbers in which the letters A and B are randomly assigned to each number. In this study, numbers with letter A are in the intervention and numbers with letter B are in the control group.

This study is a double-blind clinical trial in which the participant, the outcome assessor and the data analyst will be unaware of the treatment process. After randomization, the patients of each treatment group are introduced by researcher 1 (orology resident) to researcher 2 to evaluate the outcome. Researcher 2 ( the supervisor) is only an outcome assessor and records the results without knowing the type of treatment and its effects. A person who is an information analyst (statistician) also receives the recorded information at the end of the work and is not in the process of the intervention groups in any way. Drug injection will be done by an anesthesiologist. In each of the groups, the desired drugs is placed in the posterior fornix of the vagina by the resident 6 hours before hysteroscopy. The surgeon and the patients will not know the type of drug used, and before the surgeon enters, the removal of the probe and the drape will be done by another person, and if there is a vaginal pill, the pill will be removed so that the surgeon does not notice the presence of the vaginal pill and its type.Patients also do not know about the injectable substance.

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