Studying the effect of amniotic disc combined with standard antibiotics on improving cervicitis symptoms in women of reproductive age: A randomized controlled trial

Determining the effect of amniotic disc on cervicitis symptoms.

Clinical trial with control group, parallel, unblinded, randomized, without reference on 76 patients. Randomization with the rand function of Excel software.

In the women's clinic of Qom, two groups will be studied using a three-part data collection tool. From all individuals with the inclusion criteria, a Pap smear sample will be taken by the researcher and after confirmation by a gynecological oncologist (research assistant), both intervention and control groups will receive standard antibiotics; in the intervention group, an amniotic disc will be placed on the cervical wound; then, with an evaluation of the second and sixth weeks, both groups will be studied.

Inclusion criteria: Married women of reproductive age 15-45 years with symptoms of cervicitis. Exclusion criteria: Non-compliance with treatment and presence of abnormal pelvic conditions.

The intervention group includes women with cervicitis who receive standard antibiotic treatment including azithromycin 1g (Sanamed Pharmaceutical Company) and cefixime 400mg (Kowsar Pharmaceutical Company) as a single oral dose, along with treatment of the sexual partner with the same regimen. In addition, this group also receives a single amniotic disc (manufactured by Sinacel Company) vaginally. • The control group includes women with cervicitis who receive the same standard antibiotic treatment alone including azithromycin 1g and cefixime 400mg (both as a single oral dose) along with treatment of the sexual partner with the same antibiotic regimen.

Vaginal mucopurulent discharge; Vaginal itching; Vaginal burning; Pain during vaginal intercourse; Bleeding after vaginal intercourse; Cervical ulcer size; Severity of cervicitis symptoms; Satisfaction

In this study, stratified randomization with individual randomization was used. Participants were stratified based on three key variables: 1. Education level (diploma and less/higher than diploma) 2. Severity of cervicitis symptoms (0-4, 5-10) 3. Number of sexual intercourses per week (once or less, 2-3 times, 4 times or more) In each stratum, a random number table will be used to assign participants to two groups A and B. In this way: • Numbers between 1 and 4 were assigned to group AB • Numbers between 5 and 10 were assigned to group BA . This process will be performed separately in all combinations of the above strata (total of 12 strata). Allocation to groups was performed by an impartial person independent of the research team who will assign participants to the study groups solely based on a pre-prepared random sequence. This method will maintain allocation concealment as much as possible and prevent bias in patient enrollment.