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IRCT20221011056143N1 IRCT 2022-10-16 Karaj University of Medical Sciences The effect of rectal oxytocin suppositories compared to routine methods in reducing pain and bleeding after elective cesarean section The effect of rectal oxytocin suppositories compared to routine methods in reducing pain and bleeding after elective cesarean section - a randomized clinical trial 2022-10-31 anticipated 52 Complete https://irct.ir/trial/66292 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done as a block randomization method. So, initially, in the Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB). (AB, AB), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is the confirmation of the treatment or intervention group and B is the confirmation of the placebo group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to the treatment or placebo groups. The random process of selecting blocks and assigning people to the intervention and placebo groups will continue until the desired sample size is reached, Blinding description: For the study subjects, before the random assignment, it is explained how the work process is and they may receive one of the two treatments randomly, and the drug used for the subjects is not known in advance, the form of the intervention drug and placebo and also, the frequency and times of administration of these two will be similar, so that it is not possible for the patient to distinguish them from each other, so the patient will not know which group she is in. 2-3 Pain and bleeding after Cesaean Section. Intervention 1: Intervention group: In recovery, 10 units of intravenous oxytocin (per liter of serum) are injected and then rectal oxytocin suppositories are given. Suppositories contain 10 effective units of oxytocin. Intervention 2: Control group: In recovery, 10 units of intravenous oxytocin (per liter of serum) are injected and then placebo rectal suppositories are given. Placebo suppositories are completely similar to medicinal suppositories in terms of shape, size and color, and in terms of composition, they contain paraffin. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published. To whom: Research centers and faculty members Conditions: At the request of the researcher and faculty members Where to obtain: send email to the scientific respondent How to obtain: Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people Comments:
public Mehdi Zakikhani MD
Kamali Medical Education Center, Kamali Street, Shahada Square, Shahid Beheshti Street
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 mehdizakikhani۹۵@gmail.com Karaj University of Medical Sciences scientific Mehdi Zakikhani MD
Kamali Medical Education Center, Kamali Street, Shahada Square, Shahid Beheshti Street
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 mehdizakikhani۹۵@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Pregnant women candidates for elective cesarean surgery for the second time Age 20 to 40 years Full-term women (37 full weeks of pregnancy and singletons) who undergo active cesarean section for non-emergency reasons. A.S.A Class II Not suffering from underlying diseases such as diabetes, high blood pressure, preeclampsia, eclampsia or a history of taking certain drugs. Not suffering from hypothyroidism Insensitivity to oxytocin Absence of fetal anomalies No history of headache and migraine No history of taking psychotropic drugs No alcohol or drug addiction Complete mastery of official language conversation and the ability to read and write in Persian No meningitis at the time of study Not suffering from psychiatric diseases 20 years 40 years Female Severe drop in blood pressure during cesarean section Any arrhythmia, whether tachyarrhythmia or bradyrhythmia Heavy bleeding during cesarean section Any disruption in the delivery process that prolongs the surgical process or repeats the caesarean section, including rupture of the bladder or bowels during surgery. Hemodynamic changes during surgery, nausea and vomiting, respiratory arrest, arrhythmia and severe bleeding The occurrence of shivering and severe pain in patients after surgery The need for extra days of oxytocin or the need for other drugs such as metrogen and misopropylol O75.4 Other complications of obstetric surgery and procedures Prevention Prevention Intervention group: In recovery, 10 units of intravenous oxytocin (per liter of serum) are injected and then rectal oxytocin suppositories are given. Suppositories contain 10 effective units of oxytocin. Control group: In recovery, 10 units of intravenous oxytocin (per liter of serum) are injected and then placebo rectal suppositories are given. Placebo suppositories are completely similar to medicinal suppositories in terms of shape, size and color, and in terms of composition, they contain paraffin. Pain. Timepoint: 0.5, 1, 1.5, 3.5, 6 hours after surgery. Method of measurement: Visual analog scale questionnaire. Bleeding. Timepoint: Within 24 hours after delivery. Method of measurement: Counting gasses and blood-soaked sheets to estimate the amount of bleeding. Headache. Timepoint: 12, 24, 48 and 72 hours after surgery. Method of measurement: visual analog scale questionnaire. Shivering. Timepoint: 20, 35, 50, 65, 80 and 95 minutes after surgery. Method of measurement: Crossley and Mahajan scale. Karaj University of Medical Sciences Approved 2022-05-20 Ethics Committee of Alborz University of Medical Sciences Second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)