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

What Was Tested

The trial (phase 4) is built around Oxytocin.

Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm.

The effect of oxytocin on this outcome has not been investigated to any extent.

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 103 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy women \>/= 18 years scheduled to planned cesarean section.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: BMI \> 35; multiple birth; complications to pregnancy.

How the Study Was Run

Design: randomized, single-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2005-12 with completion listed for 2008-07.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: ST segment depression on ECG (time frame: 30 minutes).

It also tracked 1 secondary outcome, for example mean arterial blood pressure, heart rate, blood loss and symptoms as chest pain.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 103 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.