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IRCT20130812014333N209 IRCT 2023-08-27 Kermanshah University of Medical Sciences Study of the effectiveness and side effects of buccal and vaginal misoprostol in labor induction A comparative study of the effectiveness and side effects of buccal and vaginal misoprostol in labor induction 2023-09-11 anticipated 42 Complete https://irct.ir/trial/72163 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code. N/A labour induction. Intervention 1: The first intervention group of vaginal misoprostol will receive 25 micrograms of misoprostol (manufactured by Aria Pharmaceutical Company) vaginally. Intervention 2: The second intervention group will receive 25 micrograms of buccal misoprostol (between teeth and cheek mucosa). Intervention 3: The third intervention group will receive 50 micrograms of buccal misoprostol (between teeth and cheek mucosa). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahdis Akrami
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 mahdis_akrami@yahoo.com Kermanshah University of Medical Sciences scientific Dr. Maryam Zangeneh
School of Medicine, parastar boulvarde
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 mzangeneh@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Monogamous Pregnancy above 37 weeks bishop's score less than/equal to 4 Cephalic presentation live fetus The weight of the fetus is less than 4 kilograms and the amniotic fluid index is more than 5 no limit no limit Female Mothers who have contraindications for taking misoprostol (active cardiopulmonary disease, history of previous cesarean section, or history of major uterine surgery such as myomectomy and uterine reconstruction surgery). O61 Failed induction of labor Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group of vaginal misoprostol will receive 25 micrograms of misoprostol (manufactured by Aria Pharmaceutical Company) vaginally. The second intervention group will receive 25 micrograms of buccal misoprostol (between teeth and cheek mucosa). The third intervention group will receive 50 micrograms of buccal misoprostol (between teeth and cheek mucosa). Duration of labor. Timepoint: End of study. Method of measurement: Based on the time measured from induction of labor to final delivery. Nausea. Timepoint: During the study. Method of measurement: Ask the patient. Fever. Timepoint: During the study. Method of measurement: Using a thermometer. Chills. Timepoint: During the study. Method of measurement: Ask the patient. Kermanshah University of Medical Sciences Approved 2023-05-28 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)