Cardiac Effects of Oxytocin Administrated During Cesarean Section, Signs of Myocardial Ischemia

NCT00777166 | Completed Phase 4

• 1 other identifier: 2004-004929-99
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm. The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this outcome has not been investigated to any extent. In the current study, we tested the hypothesis that there was no difference in occurrence of ECG changes (ST segment depression) between two doses of oxytocin. Participants were randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion. Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest.

Conditions

Myocardial Ischemia; Hypotension; Bloodloss

Keywords

oxytocin; ST depression; cesarean section; blood loss

Outcome Measures

Primary Outcomes (1)

• ST segment depression on ECG

  30 minutes

Secondary Outcomes (1)

• mean arterial blood pressure, heart rate, blood loss and symptoms as chest pain

  60 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

oxytocin 5 units

Drug: oxytocin

2

ACTIVE COMPARATOR

oxytocin, 10 units

Drug: oxytocin

Interventions

oxytocin DRUG

oxytocin 5 units diluted with normal saline to a total volume of 10 mL

Also known as: syntocinon, Pitcotin

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women \>/= 18 years scheduled to planned cesarean section

You may not qualify if:

• BMI \> 35
• Multiple birth
• Complications to pregnancy
• Non proficiency in the Swedish language

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

University hospital Uppsala

Uppsala, Sweden

Location

MeSH Terms

Conditions

Myocardial Ischemia; Hypotension; Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ove Axelsson, Professor

  Uppsala University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: December 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

SE (1)