ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia

NCT ID: NCT01530230

Last Updated: 2012-02-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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ST depression on electrocardiograms has been reported in healthy women undergoing cesarean section in regional anesthesia. The investigators examined whether there was a difference in the occurrence of electrocardiogram changes suggestive of myocardial ischemia (ST depressions) in preeclamptic patients randomized to five or ten units of oxytocin during cesarean section with regional anesthesia.

In a double-blind randomized controlled study preeclamptic patients undergoing cesarean section under spinal anesthesia were randomized to 5 or 10 units of oxytocin, given as an intravenous bolus. A Holter monitor was used to record electrocardiograms. Non-invasive blood pressure and heart rate were monitored.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oxytocin 5 units

Group Type OTHER

oxytocin

Intervention Type DRUG

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

Oxytocin 10 units

Group Type OTHER

oxytocin

Intervention Type DRUG

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

Interventions

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oxytocin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maria Jonsson

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obsterics and Gynecology

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2004-74

Identifier Type: -

Identifier Source: org_study_id

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