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

Saint Thomas Hospital (HST)

Status and phase: Unknown; Phase 3

Conditions: Severe Preeclampsia; Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01382732

MHST2011-06

Details and patient eligibility

About

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.

Enrollment: 636 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Twin pregnancy
• Coagulation disorders
• HELLP Syndrome
• Eclampsia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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636 participants in 2 patient groups

Carbetocin

Experimental group

Description:

Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes. Ringer's Lactate 4mL applied to a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Treatment:

Drug: Carbetocin

Oxytocin

Active Comparator group

Description:

Protocol B (oxytocin + placebo) Ringer's Lactate 11mL directly into the vein in no less than two minutes. Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Treatment:

Drug: Oxytocin