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IRCT20250527065922N1 IRCT 2025-06-08 Khoram-Abad University of Medical Sciences The effect of amniotic disc in treating cervicitis symptoms Studying the effect of amniotic disc combined with standard antibiotics on improving cervicitis symptoms in women of reproductive age: A randomized controlled trial 2025-05-27 anticipated 76 Complete https://irct.ir/trial/83842 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. N/A Women with cervicitis. Intervention 1: • Intervention group: Participants in this group will receive standard antibiotics including cefixime 400 mg orally (single dose, Kowsar Company) and azithromycin 1 g orally (single dose, Thanamed Company). Each participant's sexual partner will also be treated with a similar antibiotic regimen. In addition to drug treatment, a single amniotic disc will be used in this group. The amniotic disc, derived from the human fetal amniotic membrane, is prepared by Sinacell Company, dried and sterilized. Treatment will begin after the end of menstrual bleeding. Patients are advised to refrain from sexual intercourse for two weeks. For the intervention, the patient is placed in the lithotomy position and the amniotic disc is placed on the cervical erosion area under sterile conditions using forceps. After 15 to 20 minutes of absorption, the dressing is applied and the patient can get out of bed. Intervention 2: Control group: Participants in this group will receive cefixime 400 mg orally (single dose, Kowsar Company) and azithromycin 1 g orally (single dose, Thanamed Company). Their sexual partners will also be treated with the same antibiotic. Treatment will begin after the end of menstrual bleeding. Patients are advised to abstain from sexual intercourse for two weeks. No other physical intervention or complementary therapy will be performed in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Fatemeh Jeddi
Qom, Enqelab blvd, After Alley 14, No. 380
Qom Iran (Islamic Republic of) 3715718979 +98 25 3772 0177 Jeddi.fatemeh7272@gmail.com Khoram-Abad University of Medical Sciences scientific Fatemeh Jeddi
Qom, Enqelab blvd, After Alley 14, No. 380
Qom Iran (Islamic Republic of) 3715718979 +98 25 3772 0177 Jeddi.fatemeh7272@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1) Married women of reproductive age 15-45 years. 2) Presence of symptoms of cervicitis including: pain during vaginal intercourse bleeding after vaginal intercourse vaginal itching vaginal burning purulent vaginal mucus discharge erosion (cervical ulcer). 15 years 45 years Female Non-adherence to treatment (the importance of regular treatment will be explained to the research unit and further explanations regarding adherence to treatment will be provided during the telephone call and follow-up). History of pelvic surgery. Pregnancy and breastfeeding. Cervical polyps and fibroids or other diseases related to the cervix. Any cervical malignancy and abnormal cells in a Pap smear test. N72 Inflammatory disease of cervix uteri Treatment - Other Treatment - Drugs • Intervention group: Participants in this group will receive standard antibiotics including cefixime 400 mg orally (single dose, Kowsar Company) and azithromycin 1 g orally (single dose, Thanamed Company). Each participant's sexual partner will also be treated with a similar antibiotic regimen. In addition to drug treatment, a single amniotic disc will be used in this group. The amniotic disc, derived from the human fetal amniotic membrane, is prepared by Sinacell Company, dried and sterilized. Treatment will begin after the end of menstrual bleeding. Patients are advised to refrain from sexual intercourse for two weeks. For the intervention, the patient is placed in the lithotomy position and the amniotic disc is placed on the cervical erosion area under sterile conditions using forceps. After 15 to 20 minutes of absorption, the dressing is applied and the patient can get out of bed. Control group: Participants in this group will receive cefixime 400 mg orally (single dose, Kowsar Company) and azithromycin 1 g orally (single dose, Thanamed Company). Their sexual partners will also be treated with the same antibiotic. Treatment will begin after the end of menstrual bleeding. Patients are advised to abstain from sexual intercourse for two weeks. No other physical intervention or complementary therapy will be performed in this group. Severity of cervicitis symptoms. Timepoint: Pre-study, second week, and sixth week assessments. Method of measurement: Questionnaire, Visual Analogue Scale. Size of the cervical scar. Timepoint: Pre-study, second week, and sixth week assessments. Method of measurement: Visual examination. Pain during vaginal intercourse. Timepoint: Pre-study, the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Bleeding after vaginal intercourse. Timepoint: Pre-study, the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Vaginal itching. Timepoint: Pre-study, the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Vaginal burning. Timepoint: Pre-study, the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Vaginal purulent mucous discharge. Timepoint: Pre-study, the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Satisfaction. Timepoint: the second and sixth weeks of assessment. Method of measurement: Questionnaire, Visual Analogue Scale. Number of vaginal intercourses per week. Timepoint: Pre-Study. Method of measurement: Questionnaire. Khoram-Abad University of Medical Sciences Approved 2025-05-27 Ethics Committee of Khorramabad University of Medical Sciences Qom, Enqelab blvd, After Alley 14, No. 380 Qom Ghoum Iran (Islamic Republic of)