NCT01236482

Brief Summary

In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps:

  1. 1.The investigators validate a quantitative measure of uterine tone as our primary endpoint.
  2. 2.The investigators use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each.
  3. 3.Using equipontial ratios based on the ED50, the investigators compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 8, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

September 27, 2010

Last Update Submit

November 5, 2010

Conditions

Post Partum Hemorrhage

Keywords

PregnancyPostpartum hemorrhageUterine toneOxytocinErgometrinePharmacokinetic-pharmacodynamic analysis

Outcome Measures

Primary Outcomes (1)

  • Uterine tone

    Uterine tone as measured by tissue durometry

    Up to 30 minutes

Secondary Outcomes (2)

  • Plasma levels of oxytocin

    Up to 30 minutes

  • Subjective side effects

    Up to 120 minutes

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR
Drug: Oxytocin versus oxytocin-ergometrine

Oxytocin - ergometrine

EXPERIMENTAL
Drug: Oxytocin versus oxytocin-ergometrine

Interventions

Oxytocin versus oxytocin-ergometrineDRUG

Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study

OxytocinOxytocin - ergometrine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women presenting for elective repeat cesarean delivery under regional anesthesia.
  • All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.

You may not qualify if:

  • Obstetric risk factors: Pre-eclampsia, abnormalities of placentation (eg placenta accrete, placenta previa), amnionitis, multiple gestation, preterm delivery (\< 37 completed weeks), more than three previous cesarean deliveries, previous history of ante-partum or post-partum hemorrhage.
  • Maternal medical risk factors: Chronic hypertension, cardiac disease, intracranial pathology, known allergies to oxytocin or ergometrine, autoimmune disorders, SLE, coagulation defect or anticoagulation therapy, amnionitis.
  • Women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 93510, Israel

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2010

First Posted

November 8, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 8, 2010

Record last verified: 2010-09

Locations

IL(1)