Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia

Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01382732

Enrollment

636

Registered

2011-06-27

Start date

2012-01-31

Completion date

2016-01-31

Last updated

2015-01-05

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

Conditions

Postpartum Hemorrhage, Severe Preeclampsia

Keywords

Pre-eclampsia, Postpartum hemorrhage, Carbetocin, Oxytocin

Brief summary

Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage but the hemodynamic changes associated with this pathology make the management of any kind of bleeding particularly troublesome. There are many pharmacological options, being oxytocin the first line of treatment. However there is no evidence about the safety and efficacy of carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.

Interventions

DRUGCarbetocin

Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.

DRUGOxytocin

Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Pregnant women between 28 weeks and term * Severe pre-eclampsia

Exclusion criteria

* Twin pregnancy * Coagulation disorders * HELLP Syndrome * Eclampsia

Design outcomes

Primary

Measure	Time frame	Description
Need for additional uterotonics	Six months	Number of cases allocated to one arm of the study that due to the presence of continous bleeding postpartum need the use of an additional uterotonic.

Secondary

Measure	Time frame	Description
Development of oliguria	six months	Number of cases that develop oliguria (\<30 mL/hr over a 2 hour period) after the administration of the drug.
Changes in hemodynamic status	six months	Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026