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IRCT20230227057554N1 IRCT 2023-03-18 Tehran University of Medical Sciences The effect of misoprostol, and metrogen with oxytocin in reducing of postpartum hemorrhage Investigating the incidence of postpartum hemorrhage in high-risk pregnant women who underwent cesarean section after the prophylactic administration of misoprostol, metrogen, and oxytocin compared to oxytocin alone 2023-05-20 anticipated 240 Complete https://irct.ir/trial/68856 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using the random allocation rule, people are placed in one of the study groups (intervention group A (misoprostol + oxytocin), intervention group B (metrogen + oxytocin), and control group C (oxytocin)). First, 80 letters A, 80 letters B, and 80 letters C are written on special papers that are not marked inside. Then all of them (240 pieces) are placed in a bag and for each patient, after obtaining informed consent, a piece of paper is randomly removed without replacement, and based on the letter written on it, the desired intervention is performed for the patient, Blinding description: The patient and the anesthesiologist know about the group assignment process, but the person gathering data (gynecological resident) does not know about the grouping of patients. Therefore, the study is single-blind. 3 Postpartum hemorrhage. Intervention 1: Intervention group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. After clamping the umbilical cord 400 micrograms of misoprostol (produced by Samisaz Pharmaceutical Manufacturing) is placed in the patient's sublingual space by the anesthesia technician. Intervention 2: Intervention group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. After clamping the umbilical cord, an ampoule of metrogen (0.2 mg), produced by Minoo Pharmaceutical Manufacturing, is injected into the patient by the anesthesia technician. Intervention 3: Control group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants. When: After the manuscript is published. To whom: No limitations. Conditions: Those who are allowed to request to receive nonidentifiable personal data or other documents must have a written proposal (including the type of statistical analysis) and the ethics number. any additional analysis must perform under the corresponding author's supervision. Where to obtain: Communicate with the corresponding author via email: mahboobehshirazi4@gmail.com How to obtain: Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Shirazi. Comments:
public Mahboobeh Shirazi
Yas hospital, Nejatollahi St., Karimkhan Blvd., Tehran Town.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0852 mahboobehshirazi4@gmail.com Tehran University of Medical Sciences scientific Mahboobeh Shirazi
Yas hospital, Nejatollahi St., Karimkhan Blvd., Tehran Town.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0852 mahboobehshirazi4@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Singleton term pregnant women who have an indication for termination of pregnancy (37-40 weeks). Have an indication for an elective cesarean section. At least one risk factor for postpartum bleeding (such as polyhydramnios, multiparity, having a history of postpartum bleeding, macrosomia, and anemia). 18 years 40 years Female Emergency cesarean section Abnormal fetal heartbeat Vaginal bleeding Person with unexpected bleeding during the surgery Severe anemia (hemoglobin less than 8 mg/dL) before surgery Advanced underlying diseases History of coagulation disorders Low-lying placenta, decolman or accreta previa Reaction history to the drugs O72 Postpartum hemorrhage Prevention Prevention Prevention Intervention group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. After clamping the umbilical cord 400 micrograms of misoprostol (produced by Samisaz Pharmaceutical Manufacturing) is placed in the patient's sublingual space by the anesthesia technician. Intervention group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. After clamping the umbilical cord, an ampoule of metrogen (0.2 mg), produced by Minoo Pharmaceutical Manufacturing, is injected into the patient by the anesthesia technician. Control group: In these women, the intravenous infusion of 40 units of oxytocin (produced by Aburaihan Pharmaceutical Manufacturing) in 1 liter of Ringer's serum at a rate of 10 ccs per minute for 30 minutes is done and then continued at 2 ccs per minute for one hour. Incidence of postpartum hemorrhage. Timepoint: Once, six hours after the caesarean section. Method of measurement: Number of pads used in the first six hours after the caesarean section. Hemoglobin and hematocrit concentration. Timepoint: Once, six hours after the cesarean section. Method of measurement: Complete blood count. Tehran University of Medical Sciences Approved 2023-01-11 Ethical Committee of Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd. Tehran Tehran Iran (Islamic Republic of)