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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Jonsson, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01530230
First received: February 6, 2012
Last updated: February 10, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Depression of the ST segment on electrocardiograms [ Time Frame: From start of caesarean section until 20 minutes after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01530230

Locations
Sweden
Department of Obsterics and Gynecology
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University Hospital
  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
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014