Investigation of the effects of carbetocin versus oxytocin in preventing postpartum hemorrhage in patientsundergoing elective cesarean sections

To evaluate the effect of Carbetocin versus Oxytocin in the prevention of postpartum hemorrhage (PPH) in patients undergoing elective cesarean section at Kosar Hospital in Urmia in the year 1404 (2025).

This is a phase 3 randomized, single-blind, parallel-group clinical trial comparing Carbetocin and Oxytocin, conducted on 184 patients.

A total of 184 patients (92 in each of the Carbetocin and Oxytocin groups) will be selected from among candidates undergoing elective cesarean section. The study will be conducted at Kosar Hospital in Urmia in the year 1404 (2025).Baseline patient information—including age, gravidity, parity, history of abortion, gestational age, birth weight, body mass index (at the first prenatal visit), history of myoma, presence of PROM (premature rupture of membranes), meconium-stained amniotic fluid, and fetal distress—will be recorded and compared between the two groups.

Inclusion Criteria: "Elective cesarean candidates: nulliparous, breech, or one prior cesarean, with written consent." Exclusion Criteria: : Diabetes mellitus ,Hypertension ,Multiple pregnancies ,Polyhydramnios ,Fetal macrosomia ,Maternal renal, cardiac, or hepatic diseases ,Maternal coagulation disorders ,Placental adherence disorders (placenta accreta, increta, or percreta)

Intervention Group A (Carbetocin Group), Group B (Oxytocin Group)

Primary Outcomes: volume of blood loss during cesarean section (from placental delivery to uterine suturing)، blood loss during the first 2 hours post-cesarean، Requirement for blood product transfusion within 48 hours after surgery، Changes in hemoglobin levels، Changes in hematocrit levels. Secondary Outcomes: Patients’ vital signs، Need for additional interventions to control bleeding، Drug-related adverse effects

Sampling will be carried out using the convenience sampling method among patients who are candidates for elective cesarean section and do not meet any of the exclusion criteria. Random allocation to the study groups will be performed using the permuted block randomization method in two groups with a block size of four (Sealed Envelope: 65871875657749). The randomization process will be based on a pre-designed Excel file corresponding to the determined sample size. A total of 46 blocks of four will be generated, each containing two assignments to Group A and two to Group B in varying sequences (e.g., BBAA). Each patient within a block will be assigned a unique identification code, which will be known only to the clinical evaluator responsible for assessing patient outcomes. This code will be recorded on the patient's data collection form. At the time of enrollment, patients will only be assigned the unique code. The intervention group will be revealed at the time of drug administration by the clinical evaluator, who will determine which of the two study drugs the patient will receive.

Allocation to the study groups will be performed randomly using the permuted block method in two groups with a block size of 4 (Sealed Envelope: 65871875657749). Random allocation will be done using a pre-designed Excel file based on the calculated sample size. A total of 46 blocks, each consisting of 4 allocations (with two assignments to group A and two to group B, e.g., BBAA), will be used. Each patient within a block will be assigned a unique identification code. This code will only be known to the clinical evaluator and will be recorded in the patient data collection form. Upon entry into the study, only this unique code will be assigned to the patient. The intervention group (i.e., the medication to be administered) will then be revealed at the time of drug administration by the evaluator who is aware of the allocation. Patients will remain blinded to the group assignments. In the random sampling process, each patient will be assigned a unique code that will be kept confidential. As described in the sampling and randomization method, each block and group assignment is associated with a unique code indicating the group. In this way, patients will receive only the code at study entry, and the assigned intervention will be determined at the appropriate time by the clinical evaluator.

non-demographic data files , including the main study variables ,are published online in excel format.

The data will be published after the publication of the protocol paper and the original paper of the study results by the corresponding researcher.

The data will be available online without any request.

For analysis and study by other interested researchers.

The data will be available online.

The data will be available online without any request.