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IRCT20191115045453N1 IRCT 2019-12-12 Gorgan University of Medical Sciences Comparing the Effects of Vaginal Misoprostol, Vaginal Trinitroglycerin (TNG) and oral Evening Primrose Oil in Cervical Ripening at term pregnancy, Comparing the Effects of Vaginal Misoprostol, Vaginal Trinitroglycerin (TNG) and oral Evening Primrose Oil in Cervical Ripening at term pregnancy 2019-12-06 anticipated 201 Complete https://irct.ir/trial/43861 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomly assigned to intervention (A) and Control (B) groups in the study by Block Randomization . That is, by using a dice that has 6 funds, samples are assigned to their groups on any form, and each number is assigned to one of the table blocks, which shows its own state. Group A (vaginal nitroglycerin) and group B (edible capsule primrose evening) and group C (vaginal misoprostol). The complete list of random blocks was presented to the principal researcher by the Epidemiological advisor of the study, Blinding description: The implementation of this study is a blind one (single blinding). In this study, the assessments of the consequences of the study are blind. So that the principal investigator prescribed the drug and the type of group is informed, but the assessment of the consequences for gynecology resident is not in the current purpose of the study and the type of drugs prescribed. 3 pregnancy. Intervention 1: Intervention group: In the intervention group A Pearl TNG Vaginal 400 mg construction of Zahravi company will be prescribed a dose of 4 to 6 hours to 3. Intervention 2: Intervention group: In group B, the capsule of evening primrose evening, 1000 mg capsules of primroses (Barij Essence Company with food and drug verification) will be given every 4 to 6 hours maximum of 3 doses. Intervention 3: Control group: 25 MCG of a misoprostol tablet (a quarter of 100 microgram Mizotak tablets, pharma Abhan) after humidifying the distilled water, every 4th6 hours in a vaginal form will be administered to 3 doses. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the original outcome, or the possibility of sharing. When: Start of access period 6 months after printing results To whom: Only for researchers working in academic and academic institutions Conditions: metanalysis and systematic review Where to obtain: investigator through e-mail: sanazalizadehmd@gmail.com How to obtain: After receiving the email by the researcher, within 14 business days, the application will be examined and the documentation is provided to the applicant. Comments:
public Sanaz Alizadeh
No. 3, Alborz St., Ghaemshahr ., Mazandaran, Iran
Ghaemshahr Iran (Islamic Republic of) 4765694769 +98 17 3222 4477 sanazalizadehmd@gmail.com Gorgan University of Medical Sciences scientific Sanaz Alizadeh
No. 3, Alborz St., Ghaemshahr ., Mazandaran, Iran
Ghaemshahr Iran (Islamic Republic of) 4765694769 0098173224477 sanazalizadehmd@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Pregnant women (primigravid) the term pregnancy (40 weeks onwards) Bishop Score less or equal to 4 candidate for induction of childbirth no limit no limit Female History of past uterine surgery Use of intrauterine contraceptives (IUD) Any medicinal allergy Developing systemic and localized infection Developing known diseases such as diabetes, hypertension and... Existence of any uterine abnormalities. Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group A Pearl TNG Vaginal 400 mg construction of Zahravi company will be prescribed a dose of 4 to 6 hours to 3. Intervention group: In group B, the capsule of evening primrose evening, 1000 mg capsules of primroses (Barij Essence Company with food and drug verification) will be given every 4 to 6 hours maximum of 3 doses. Control group: 25 MCG of a misoprostol tablet (a quarter of 100 microgram Mizotak tablets, pharma Abhan) after humidifying the distilled water, every 4th6 hours in a vaginal form will be administered to 3 doses Cervical ripening according to Bishop Score. Timepoint: Before and after 4 hours of intervention. Method of measurement: Bishop's rating table (between 0 and 13). Baby Apgar Score. Timepoint: Minutes One and 5. Method of measurement: Apgar Scoring System (0 to 10). Duration of prescribing medications to childbirth. Timepoint: Time of prescription medication and delivery time. Method of measurement: Based on minutes. Drug side effects. Timepoint: Prescribed time of medication and 4 hours after drug Administration. Method of measurement: Nausea, vomiting, vaginal bleeding, fever and chills, blurred vision, diarrhea, feeling of bitter taste in the mouth, vaginal pain. Vaginal bleeding rate. Timepoint: Postpartum. Method of measurement: It will be measured with a scale of zero to 3 (= 0 = no bleeding, 1 = bleeding), 2 = Low menstrual bleeding, 3 = severe bleeding with clot excretion. Gorgan University of Medical Sciences Approved 2019-10-09 Ethics Committee of Golestan University of Medical Sciences central organization of Golestan University of Medical Sciences, Hirkan Drive, Gorgan Gorgan Golestan Iran (Islamic Republic of)