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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530230
• Other study ID #: 2004-74
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: February 10, 2012
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: February 2012
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• oxytocin
Intravenous bolus dose given during 1 minute after clamping of the umbilical cord

Locations

Country	Name	City	State
Sweden	Department of Obsterics and Gynecology	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression of the ST segment on electrocardiograms		From start of caesarean section until 20 minutes after delivery	No
Secondary	Mean arterial pressure and heart rate.		From start of caesarean section until 20 minutes after delivery	No