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

Study Overview
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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.

Official Title
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Randomised Study on Cardiac Effects of Oxytocin During Caesarean Section in Preeclamptic Women

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: oxytocin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oxytocin 5 units<br> | Drug: oxytocin<br>* Intravenous bolus dose given during 1 minute after clamping of the umbilical cord<br>|
| Other: Oxytocin 10 units<br> | Drug: oxytocin<br>* Intravenous bolus dose given during 1 minute after clamping of the umbilical cord<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression of the ST segment on electrocardiograms |  | From start of caesarean section until 20 minutes after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure and heart rate. |  | From start of caesarean section until 20 minutes after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, electrocardiography, heart, hypotension, ischemia, oxytocin, preeclampsia, regional anesthesia, ECG changes suggestive of myocardial ischemia