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IRCT20240706062338N1 IRCT 2024-07-17 Islamic Azad University Investigating the effect of amniotic pads on the treatment of cervicitis A comparative study of the effect of amniotic pads and cryo on the treatment of cervicitis in patients with cervicitis: A Clinical Trial Study 2024-07-19 anticipated 100 Complete https://irct.ir/trial/77748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, women aged 20-55, based on symptoms and clinical examination and pap smear results, have mild and moderate cervicitis, in two treatment groups: an experimental group treated with amniotic pads and a control group, treated with cryo (in each group 50 people) will be. The samples will be selected using random sampling method. The samples will be distributed in such a way that two types of colored cards will be printed according to the number of samples in each group, and women will choose one of the cards upon entering the study and will be randomly distributed among the two groups according to the color of the card. The patient and the relevant doctor will not know the type of special color card and the study will be double-blind, Blinding description: In this study, women aged 20-55, based on symptoms and clinical examination and pap smear results, have mild and moderate cervicitis, in two treatment groups: an experimental group treated with amniotic pads and a control group, treated with cryo (in each group 50 people) will be. Written consent will be obtained from eligible research units to participate in the research.The samples will be selected using random sampling method. The samples will be distributed in such a way that two types of colored cards will be printed according to the number of samples in each group, and women will choose one of the cards upon entering the study and will be randomly distributed among the two groups according to the color of the card. The patient and the relevant doctor will not know the type of special color card and the study will be double-blind. N/A Cervicitis. Intervention 1: Intervention group: The experimental group will be treated with amniotic pads. After the clinical examination and pap smear and definitive diagnosis of cervicitis, the cervix will be washed and moistened with normal saline under direct vision. Then, the amniotic membrane pad will be completely placed on the cervical wound under a colposcopy guide or the naked eye. Then a piece of Vaseline will be placed on the pad. After a day, the vaseline gas will come out. 3 weeks later, the visit and examination will be done again. This process will be done twice if necessary.The amniotic disc manufacturer is Sinacell, a knowledge-based company, and its product number is AMD020830- 03. Intervention 2: Control group: They will be treated with cryo.The doctor inserts a tool called a cryoprobe into the vagina and presses it on the cervix for 3 minutes. Nitrogen gas at a temperature of -50 degrees Celsius cools the metal and creates an ice ball on the cervix, this ice ball destroys abnormal cells. 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 There is no further information.
public Roya Motavalli
Islamic Azad University., Basij Street
Ardabil Iran (Islamic Republic of) 5615731567 +98 45 3372 8024 Mrmotavalli@yahoo.com Islamic Azad University scientific Roya Motavalli
Islamic Azad University., Basij Street
Ardabil Iran (Islamic Republic of) 5615731567 +98 45 3371 1060 Mrmotavalli@yahoo.com Islamic Azad University Iran (Islamic Republic of) - Married women and having an age of 20-55 years - Patient consent to participate in this study -Women with acute and chronic cervicitis referring to the office based on clinical examination - Pap smear test results indicate mild or moderate cervicitis 20 years 55 years Female -Women with a positive pap smear test for malignancy and CIN - Pregnant women - Abnormal result of cervical biopsy Vaginal spotting or bleeding of unknown cause Chronic infection of unknown cause - Menstrual bleeding N72 Inflammatory disease of cervix uteri Treatment - Other Treatment - Devices Intervention group: The experimental group will be treated with amniotic pads. After the clinical examination and pap smear and definitive diagnosis of cervicitis, the cervix will be washed and moistened with normal saline under direct vision. Then, the amniotic membrane pad will be completely placed on the cervical wound under a colposcopy guide or the naked eye. Then a piece of Vaseline will be placed on the pad. After a day, the vaseline gas will come out. 3 weeks later, the visit and examination will be done again. This process will be done twice if necessary.The amniotic disc manufacturer is Sinacell, a knowledge-based company, and its product number is AMD020830- 03. Control group: They will be treated with cryo.The doctor inserts a tool called a cryoprobe into the vagina and presses it on the cervix for 3 minutes. Nitrogen gas at a temperature of -50 degrees Celsius cools the metal and creates an ice ball on the cervix, this ice ball destroys abnormal cells. Cervicitis. Timepoint: In this study, those who have mild and moderate cervicitis based on clinical examination and pap smear results will be included in the study. 3 weeks after the treatment, the visit and examination will be done again. Method of measurement: Clinical symptoms, clinical examination, pap smear results. Islamic Azad University Approved 2024-04-16 Committee of ethics in research of Islamic Azad University-Ardebil branch Basij Square., Islamic Azad University of Ardabil branch Ardabil Ardabil Iran (Islamic Republic of)