Postpartum Hemorrhage Clinical Trial
Official title:
Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial
Verified date | January 2015 |
Source | Saint Thomas Hospital, Panama |
Contact | n/a |
Is FDA regulated | No |
Health authority | Panama: Ministry of Health |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 636 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Pregnant women between 28 weeks and term - Severe pre-eclampsia Exclusion Criteria: - Twin pregnancy - Coagulation disorders - HELLP Syndrome - Eclampsia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Panama | Saint Thomas H | Panama |
Lead Sponsor | Collaborator |
---|---|
Saint Thomas Hospital, Panama |
Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
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