The evaluation of consuming evening primrose oil with misoprostol on cervical preparation before hysteroscopy

Comparison of evening primrose oil with misoprostol in cervical opening preparation in hysteroscopy candidate patients

Clinical trial with control group with parallel groups, single blind, randomized phase 3 on 102 patients. The rand function of Excel software was used for randomization

Patients in the intervention group will be inserted vaginally in the back of the neck by the interventionist in two sessions, 6 and 2 hours before the operation. In the control group, under the same conditions, 200 micrograms 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.

Women candidates for hysteroscopy Having informed consent to enter the study No need for laparoscopy - no pregnancy - - no cervical and vaginal infection - no bleeding disorders - no use of anticoagulants no epilepsy and blood pressure - no Anomalies and insufficiency of the cervix - absence of Müllerian anomalies - no ban on the use of prostaglandins Exclusion criteria: Lack of consent to continue studying

In the intervention group, the effect of evening primrose capsules on cervical dilatation will be investigated. In the control group, misoprostol will be added to compare its effect with evening primrose capsules.

cervical opening preparation

First, we make a column of random numbers, so the Rand() function is used in Excel. Then we will consider the random numbers below half as a block of 4 and the numbers above half as a block of 6. For this purpose, symbols A and B will be used for the intervention of evening primrose oil capsules and misoprostol tablets, respectively. The way of doing the work is that in a block of 4, two interventions A and two interventions B will be written in a column one after the other. Then, 4 random numbers will be assigned to this 4 column using the Rand() function. Then the order of assigned random numbers will be sorted from small to large so that the order of our intervention codes will also change. The same work will be repeated for the block of 6. This process continues until we reach an equal number of control and intervention groups. After generating random numbers without repetition, a number is assigned to each assigned sequence, which, along with the type of intervention received, is placed inside a sealed envelope, the contents of which are not known, so that the operating room nurse can qualify for each patient. He takes the condition of one of the 102 envelopes and after tearing the letter, informs the person in charge of prescribing the medicine of the intervention group.

Candidate patients are interviewed by the researcher when they visit. Patients are requested to participate in this study if they have consent. In case of patient's consent, first the goals and conditions of the study are explained to the patient and a written consent form is obtained from the patient. Then, using Excel software, the patients will be randomly assigned to two control (n=51) and intervention (n=51) groups. And the interventionist will insert the desired drugs, and as a result, only the participant from The type of intervention will be uninformed

Part of the data related to the main outcome will be shared

From 2025

Researchers working in academic institutions

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