NCT01530230

Brief Summary

The investigators examined whether there was a difference in the occurrence of ST depressions after injection of five or ten units of oxytocin, in preeclamptic patients delivered by caesarean section (CS) under regional anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

February 6, 2012

Last Update Submit

February 10, 2012

Conditions

Preeclampsia

Keywords

cesarean sectionelectrocardiographyhearthypotensionischemiaoxytocinpreeclampsiaregional anesthesiaECG changes suggestive of myocardial ischemia

Outcome Measures

Primary Outcomes (1)

  • Depression of the ST segment on electrocardiograms

    From start of caesarean section until 20 minutes after delivery

Secondary Outcomes (1)

  • Mean arterial pressure and heart rate.

    From start of caesarean section until 20 minutes after delivery

Study Arms (2)

Oxytocin 5 units

OTHER
Drug: oxytocin

Oxytocin 10 units

OTHER
Drug: oxytocin

Interventions

oxytocinDRUG

Intravenous bolus dose given during 1 minute after clamping of the umbilical cord

Oxytocin 10 unitsOxytocin 5 units

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with preeclampsia undergoing CS under spinal anesthesia. Preeclampsia was diagnosed if blood pressure was ≥ 140/90 mm Hg and if proteinuria of more than 1000 mg/day persisted.

You may not qualify if:

  • multiple birth,
  • obesity (body mass index \> 35),
  • age \< 18 years,
  • complications of the pregnancy other than preeclampsia or non-proficiency in the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obsterics and Gynecology

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Pre-EclampsiaHypotensionIschemia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

November 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

SE(1)