ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Preeclampsia |
Drug: oxytocin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Randomised Study on Cardiac Effects of Oxytocin During Caesarean Section in Preeclamptic Women |
- Depression of the ST segment on electrocardiograms [ Time Frame: From start of caesarean section until 20 minutes after delivery ] [ Designated as safety issue: No ]
- Mean arterial pressure and heart rate. [ Time Frame: From start of caesarean section until 20 minutes after delivery ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Oxytocin 5 units |
Drug: oxytocin
Intravenous bolus dose given during 1 minute after clamping of the umbilical cord
|
| Oxytocin 10 units |
Drug: oxytocin
Intravenous bolus dose given during 1 minute after clamping of the umbilical cord
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Maria Jonsson, Principal investigator, Uppsala University Hospital |
| ClinicalTrials.gov Identifier: | NCT01530230 History of Changes |
| Other Study ID Numbers: | 2004-74 |
| Study First Received: | February 6, 2012 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Uppsala University Hospital:
|
cesarean section electrocardiography heart hypotension ischemia |
oxytocin preeclampsia regional anesthesia ECG changes suggestive of myocardial ischemia |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Oxytocin Oxytocics |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013