ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia
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ClinicalTrials.gov Identifier: NCT01530230 |
Recruitment Status :
Completed
First Posted : February 9, 2012
Last Update Posted : February 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preeclampsia | Drug: oxytocin | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Official Title: | Randomised Study on Cardiac Effects of Oxytocin During Caesarean Section in Preeclamptic Women |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- Depression of the ST segment on electrocardiograms [ Time Frame: From start of caesarean section until 20 minutes after delivery ]
- Mean arterial pressure and heart rate. [ Time Frame: From start of caesarean section until 20 minutes after delivery ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530230
Sweden | |
Department of Obsterics and Gynecology | |
Uppsala, Sweden, 751 85 |
Responsible Party: | Maria Jonsson, Principal investigator, Uppsala University Hospital |
ClinicalTrials.gov Identifier: | NCT01530230 |
Other Study ID Numbers: |
2004-74 |
First Posted: | February 9, 2012 Key Record Dates |
Last Update Posted: | February 13, 2012 |
Last Verified: | February 2012 |
cesarean section electrocardiography heart hypotension ischemia |
oxytocin preeclampsia regional anesthesia ECG changes suggestive of myocardial ischemia |
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Oxytocin |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs |