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

NCT01382732 | Unknown Phase 3

• 1 other identifier: MHST2011-06
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Preeclampsia; Postpartum Hemorrhage

Keywords

Pre-eclampsia; Postpartum hemorrhage; Carbetocin; Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of oliguria

  six months

• Changes in hemodynamic status

  six months

Study Arms (2)

Carbetocin

EXPERIMENTAL

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

Oxytocin

ACTIVE COMPARATOR

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

Interventions

Carbetocin DRUG

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

Also known as: Lonactene

Carbetocin

Oxytocin 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

Also known as: Pitocin

Oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women between 28 weeks and term
• Severe pre-eclampsia

You may not qualify if:

• Twin pregnancy
• Coagulation disorders
• HELLP Syndrome
• Eclampsia

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Postpartum Hemorrhage

Interventions

carbetocin; Oxytocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Osvaldo A Reyes, MD

  Saint Thomas Hospital, Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

PA (1)