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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
Sponsor:
Information provided by (Responsible Party):
Maria Jonsson, Uppsala University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: oxytocin Not Applicable

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Depression of the ST segment on electrocardiograms [ Time Frame: From start of caesarean section until 20 minutes after delivery ]

Secondary Outcome Measures :
  1. Mean arterial pressure and heart rate. [ Time Frame: From start of caesarean section until 20 minutes after delivery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Locations
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Sweden
Department of Obsterics and Gynecology
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University Hospital
More Information
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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
Keywords provided by Maria Jonsson, Uppsala University Hospital:
cesarean section
electrocardiography
heart
hypotension
ischemia
 oxytocin
preeclampsia
regional anesthesia
ECG changes suggestive of myocardial ischemia
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Oxytocin
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs