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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT00777166
First received: October 21, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Myocardial Ischemia
Hypotension
Bloodloss
Drug: oxytocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Oxytocin Used During Cesarean Section

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • ST segment depression on ECG [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean arterial blood pressure, heart rate, blood loss and symptoms as chest pain [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 103
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
oxytocin 5 units
Drug: oxytocin
oxytocin 5 units diluted with normal saline to a total volume of 10 mL
Other Names:
  • syntocinon
  • Pitcotin
Active Comparator: 2
oxytocin, 10 units
Drug: oxytocin
oxytocin 10 units diluted with normal saline to at total volume of 10 mL.
Other Names:
  • Syntocinon
  • Pitcotin

Detailed Description:

All healthy term participants scheduled to undergo elective caesarean section under spinal anaesthesia at the Department of Obstetrics and Gynecology, University Hospital, Uppsala Sweden and who were > 18 years old, were candidates for inclusion in the study. .

The study was approved by the regional ethics committee and informed written consent was obtained from each participant.

ECGs were recorded by continuous ambulatory ECG (Holter) monitoring (GE Medical systems SEER/MARS, UK) during the peroperative period utilizing leads V3, V5 and avF. As secondary outcomes, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest and, Troponin I levels 12 hours postoperatively, were recorded. Also, as secondary outcomes, differences in blood pressure, heart rate, and blood loss were measured.

Before induction of anaesthesia, patients received 1000 mL of lactated Ringer's solution intravenously. Thereafter an additional 500-1000 mL of lactated Ringer's solution or 500 mL Hydroxyethyl starch was infused if considered needed by the anaesthesiologist.

Spinal anaesthesia was established in the sitting position at lumbal interspace L2/L3 or L3/L4. Non invasive blood pressure (systolic, diastolic and mean arterial pressure, MAP) and heart rate was monitored every 2 minutes, throughout surgery. Oxytocin was given as an intravenous bolus dose immediately after clamping of the umbilical cord. Blood loss during the operation was estimated and recorded. During surgery, any spontaneous complaints by the patients of symptoms as chest pain, shortness of breath and feeling of heaviness on the chest, was recorded as well as duration of symptoms. Episodes of chest pain were assessed with the visual analogue scale (VAS).

Troponin I, as a marker of ischemic myocardial damage, was sampled 12 hours postoperatively.

The incidence of ECG changes related to different doses of intravenous bolus doses of oxytocin (5 and 10 units) during caesarean section is unknown. In a pilot study preceding the present study, 5 units oxytocin were administrated and the incidence of ECG changes was 15%. With the assumption that ECG changes could occur in 50% of subjects receiving 10 units oxytocin and based on 0.8 power to detect a significant difference (P = 0.05, two-sided), 25 patients were required for each study group. An interim analysis performed after inclusion of 50 patients revealed that ECG-changes occured in 8 and 24 % respectively in the two groups of 5 and 10 units of oxytocin. An additional 50 patients were allocated and a second interim analysis planned.

A computer-generated randomisation list with block of four was drawn up by a statistician and given to the pharmacy department who performed the randomisation. The procedure ensured allocation concealment.

All participants, health care providers, investigators and other persons (cardiologist) were blinded to treatment assignment for the duration of the study.

The Statistical Package for Social Sciences (SPSS) for Windows, version 15.0, was used (SPSS, Inc., Chicago, IL, USA). To compare group distributions the chi-squared test or Fisher's exact test was applied and the Mann-Whitney U-test or t-test for continuous variables. A p-value < 0.05 was considered to indicate a significant difference

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI > 35
  • Multiple birth
  • Complications to pregnancy
  • Non proficiency in the Swedish language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777166

Locations
Sweden
University hospital Uppsala
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Ove Axelsson, Professor Uppsala University, Sweden
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT00777166     History of Changes
Other Study ID Numbers: 2004-004929-99
Study First Received: October 21, 2008
Last Updated: March 13, 2014
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
European Union: European Medicines Agency

Keywords provided by Uppsala University:
oxytocin
ST depression
cesarean section
blood loss

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Hemorrhage
Hypotension
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014