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

Not Applicable

Completed

• Conditions: Preeclampsia
• Interventions: Drug: oxytocin

• Registration Number: NCT01530230
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-02
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxytocin 10 units	oxytocin	-
Oxytocin 5 units	oxytocin	-

Primary Outcome Measures

Name	Time	Method
Depression of the ST segment on electrocardiograms	From start of caesarean section until 20 minutes after delivery

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure and heart rate.	From start of caesarean section until 20 minutes after delivery

Trial Locations

Locations (1)

Department of Obsterics and Gynecology; 🇸🇪 Uppsala, Sweden