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Investigation of the effects of carbetocin versus oxytocin in preventing postpartum hemorrhage

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140420017365N5
Enrollment
184
Registered
2025-07-27
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood loss after cesarean. Postpartum hemorrhage

Interventions

Intervention 1: Intervention group: Intervention Group A (Carbetocin Group):In the carbetocin group, to minimize the risk of hypotension caused by spinal anesthesia, all patients will receive an infus

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: All patients who are candidates for elective cesarean section , including nulliparous women , breech presentations , and those with a history of one previous cesarean , provided that they have signed an informed written consent.

Exclusion criteria

Exclusion criteria: diabetes hypertension multiple pregnancy polyhydramnios macrosomia kidney , heart and liver diseases Maternal coagulation disorders placental attachment disorders (accreta , increta and percreta)

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss. Timepoint: from placental delivery to uterine suturing. Method of measurement: Measurement of Blood Loss: Blood volume will be measured by recording the amount collected in the suction device and weighing all surgical gauzes and laparotomy sponges before and after surgery. A non-absorbent plastic sheet will be placed at the beginning of the procedure, and all pre-weighed materials will be collected on it. After surgery, the materials will be reweighed. The difference in weight (in grams) will be recorded, with each gram considered equivalent to 1 mL of blood loss.;Postoperative blood loss during the first 2 hours after cesarean section. Timepoint: during the first 2 hours after cesarean section. Method of measurement: Blood Volume and Blood Loss Estimation:The blood volume in non-pregnant women is calculated using the following formula:Blood volume (mL) = (50 × height in inches) + (25 × weight in pounds) / 2In pregnancy, blood volume increases by approximately 30–60% (about 1500–2000 mL) in women with average body size and no hypovolemia.During delivery, pregnant women can typically tolerate blood loss nearly equal to this additional volume without a significant drop in hematocrit.If blood loss is less than the pregnancy-induced blood volume increase, hematocrit remains stable in the acute phase and for the first few days postpartum.However, if the postpartum hematocrit is lower than the admission hematocrit, the estimated blood loss corresponds to the amount of volume lost, with every 500 mL of blood loss resulting in approximately a 3% decrease in blood volume.In this study, blood loss for each patient will be estimated using the difference between pre-delivery and 24-hour postpartum hematocrit levels.;Need for blood product transfusion within 48 hours post-surgery. Timepoint: within 48 hours post-surgery. Method of measurement: The requirements for transfusion of packed cells (P.C), fresh frozen plasma (FFP), and platelets will be docum

Secondary

MeasureTime frame
Patients vital signs. Timepoint: before the intervention, then every 10 minutes for two times, followed by every 30 minutes for two times, and subsequently every 30 minutes for up to two hours. Method of measurement: Patients' vital signs — including heart rate, systolic blood pressure, diastolic blood pressure, and body temperature — will be recorded before the intervention, then every 10 minutes for two times, followed by every 30 minutes for two times, and subsequently every 30 minutes for up to two hours. Blood pressure and heart rate will be continuously monitored and documented.;Need for hemorrhage control. Timepoint: within 48 hours postpartum. Method of measurement: The indications for administration of anticoagulant drugs and/or surgical interventions will be evaluated within 48 hours postpartum.;Adverse drug effects. Timepoint: first 6 hours after surgery. Method of measurement: The incidence of headache, fever, chills, nausea, and vomiting will be assessed in all patients during the first 6 hours after surgery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoriyeh Gasempoursore

Oroumia University of Medical Sciences

horiya.gsmp93@gmail.com+98 44 3346 0998

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026