NCT00481533

Brief Summary

Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health. Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

June 1, 2007

Status Verified

May 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

Blood Loss, Surgical

Keywords

Cesarean DeliveryUterine Contractility

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    During surgery

Secondary Outcomes (2)

  • Effectiveness of Uterine Contraction

    During surgery

  • Side Effects

    During surgery

Interventions

Methyl-Ergonovine-OxytocinDRUG
OxytocinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cesarean section secondary to failure to progress in labour
  • First stage of labour
  • Received oxytocin for at least 4 hours

You may not qualify if:

  • Require General Anesthesia
  • Cardiac Disease
  • Hypertension
  • Predisposition to uterine atony and postpartum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

  • Balki M, Dhumne S, Kasodekar S, Kingdom J, Windrim R, Carvalho JC. Oxytocin-ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest. BJOG. 2008 Apr;115(5):579-84. doi: 10.1111/j.1471-0528.2007.01658.x.

    PMID: 18333937DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jose CA Carvalho, MD PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

June 1, 2005

Study Completion

January 1, 2007

Last Updated

June 1, 2007

Record last verified: 2007-05

Locations

CA(1)