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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Preeclampsia, Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Carbetocin
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 28 weeks and term Severe pre-eclampsia Exclusion Criteria: Twin pregnancy Coagulation disorders HELLP Syndrome Eclampsia
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbetocin<br>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 | Drug: Carbetocin<br>* Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.<br>* Other names: Lonactene;|
| Active Comparator: Oxytocin<br>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 | Drug: Oxytocin<br>* Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of oliguria | Number of cases that develop oliguria (<30 mL/hr over a 2 hour period) after the administration of the drug. | 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. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia, Postpartum hemorrhage, Carbetocin, Oxytocin