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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
636
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL 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
Saint Thomas H
Panama City, Provincia de Panamá, Panama
RECRUITINGNeed for additional uterotonics
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.
Time frame: Six months
Development of oliguria
Number of cases that develop oliguria (\<30 mL/hr over a 2 hour period) after the administration of the drug.
Time frame: six months
Changes in hemodynamic status
Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.
Time frame: six months
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