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

NCT ID: NCT01382732

Last Updated: 2015-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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Severe Preeclampsia Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Carbetocin

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

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.

Oxytocin

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Interventions

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Carbetocin

Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Lonactene Pitocin

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo A Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas H

Panama City, Provincia de Panamá, Panama

Site Status RECRUITING

Countries

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Panama

Facility Contacts

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Osvaldo A Reyes, MD

Role: primary

o11(507)65655041

Other Identifiers

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MHST2011-06

Identifier Type: -

Identifier Source: org_study_id

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