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NCT Number: NCT01530230

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

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.

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Key information

Conditions

Preeclampsia Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Hypotension Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obsterics and Gynecology

Uppsala, 751 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Intravenous bolus dose given during 1 minute after clamping of the umbilical cord

Primary outcomes

  1. Depression of the ST segment on electrocardiograms

    Time frame: From start of caesarean section until 20 minutes after delivery

Secondary outcomes

  1. Mean arterial pressure and heart rate.

    Time frame: From start of caesarean section until 20 minutes after delivery

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 9, 2012
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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