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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01382732
Other study ID # MHST2011-06
Secondary ID
Status Recruiting
Phase Phase 3
First received June 24, 2011
Last updated January 1, 2015
Start date January 2012
Est. completion date January 2016

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

Drug:
Carbetocin
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
Oxytocin
Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Locations

Country Name City State
Panama Saint Thomas H Panama

Sponsors (1)

Lead Sponsor Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

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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