Comparing the effects of carbetocin and oxytocin in preventing postpartum hemorrhage in patients undergoing elective cesarean section: a double-blind randomized controlled trial.

A comparative study of carbetocin versus oxytocin in the prevention of postpartum hemorrhage in patients undergoing cesarean section.

The double-blind clinical trial has a control group of 500 patients who are candidates for elective caesarean section, and the patients are entered into two study groups in parallel using simple randomization. Phase 2-3 is a trial.

The number of 500 patients was randomly divided 1:1 into two groups (control and intervention groups). The method of assigning people to study groups will be simple randomization. The study is double-blind - from the point of view of the evaluator and the patient, but not blind from the point of view of the study administrator. Place of study Imam Khomeini Hospital Complex (RA), Yas Hospital Complex

Inclusion criteria: patients who are candidates for elective cesarean section who will undergo spinal anesthesia and have signed written informed consent also: Absence of severe underlying disease (heart-liver-kidney-pulmonary) and mental disabilities.Cesarean section not due to placenta accreta and previa. Exclusion criteria: Patients in whom we have to perform general anesthesia for any reason. Postpartum bleeding for a reason other than uterine atony

Intervention group: After the removal of the placenta, 100 micrograms of intravenous carbetocin ampoule is administered. Control group: After the placenta is removed, 5 units of oxytocin are injected intravenously. Next, 20 units of intravenous oxytocin are administered as an infusion in one liter of Linger lactate serum or 0.9% normal saline during 2 hours when the patient is in the operating room and recovery, and then another 20 units of oxytocin are administered during 8 hours.

Postpartum hemorrhage

Allocation of patients into intervention and control groups will be done randomly with a ratio of 1:1 and using the blocking method. Bi-allelic blocks of size 4 will be used for this purpose. AABB, ABAB, BBAA, BABA,.... We determine the sequence through the following site: Sealedenvelope.com/simple-randomizer/v1/lists. This program can generate random numbers and assign participants to groups based on a defined random sequence.

We allocate the participants between two study groups A and B based on a defined random sequence. The method of random allocation will be explained to the patients, but the patient does not know which treatment group he is in. The study is double-blind - from the point of view of the evaluator and the patient, but not from the point of view of the main study administrator.

There is no further information

The results of the study data will be given to the company in the form of articles and reports, and the data will be provided anonymously if needed and requested by the company manager or the editor of the article.

The access period starts 6 months after the results are printed, only by the editor of the article anonymously or the company responsible

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