Condition category
Pregnancy and Childbirth
Date applied
14/03/2018
Date assigned
16/05/2018
Last edited
16/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Oxytocin is a drug routinely used in women to induce contraction of the uterus and prevent bleeding after childbirth. However it has side effects on the blood pressure and the heart which in some patients could lead to serious events.
This study aims to further investigate the effects of oxytocin on the human heart and blood vessels.
Who can participate?
Women aged 18 and over scheduled for termination of pregnancy in first trimester

What does the study involve?
Participants are randomly assigned to one of two groups. Those in the first group receive Oxytocin injections either early or late during the medical abortion, whilst under general anaesthetic. Those in the second group receive a placebo (dummy) injection either early or late during the medical abortion, whilst under general anaesthetic.
Participants are monitored using a pain-free device that analyses the pulse wave (change in blood volume as the heart contracts) in the finger, and a system that monitors blood pressure, heart rate and heart activity during the anaesthetic.

What are the possible benefits and risks of participating?
Participants may benefit from further knowledge about the cardiovascular effects of oxytocin in a clinical setting. The study protocol does not differ from standard clinical procedure, except randomization and further non-invasive, non-painful monitoring.

Where is the study run from?
Skåne University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
August 2012 – January 2017

Who is funding the study?
1. Lund University (Sweden)
2. Region Skåne (Sweden)

Who is the main contact?
Professor Per Olofsson (Scientific)
per.olofsson@med.lu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Per Olofsson

ORCID ID

http://orcid.org/0000-0001-7840-525X

Contact details

Lund University
Box 117
Lund
22100
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Effects of oxytocin and anaesthesia on vascular tone in pregnant women: a randomised double-blind placebo-controlled study using non-invasive pulse wave analysis

Acronym

Study hypothesis

Oxytocin decreases vascular tone and elevates cardiac output in first trimester pregnacy

Ethics approval

Regional Research Ethics Committee in Lund, 13/12/2012, ref: 2012/649

Study design

Randomised double-blind placebo-controlled single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional file (in Swedish)

Condition

Vascular tone and hemodynamic change in pregnancy

Intervention

Participants are randomised by a web-based random number generator to a treatment or placebo group. Those in the treatment group receive 8.3 µg (5 U) Oxytocin by injection during the first trimester surgical evacuation of the gravid uterus under general anaesthesia. Those in the control group receive a placebo injection. The injections are administered once either early or late in the procedure, in a double-blind fashion.
The effects of oxytocin on the heart and the vascular tree are assessed using digital photoplethysmography pulse wave analysis (DPA) variables. The Meridian DPA (TM) works through an infra-red light emitting diode and receiver, measuring light absorption through the finger. The pulse wave through the finger augments the light absorption, and computer analysis generates a pulse volume curve. From the analysis of the waveform of this curve, hemodynamic estimates are computed and presented as 17 different variables. Some of these are shown to have the best repeatability, these are used in this study.
Also, heart rate, mean arterial blood pressure and electrocardiographic ST index are recorded. These variables are noted before and after induction of anaesthesia and 1 minute after each injection. No further follow up. DPA variables together with the other variables make it possible to assess the LV ejection function and vascular tone, possibly differentiating between that of large or small arteries.

Intervention type

Drug

Phase

Drug names

Oxytocin, Propofol

Primary outcome measures

The effect of oxytocin on vascular tone and cardiac LV ejection fraction is assessed using digital photoplethysmography pulse wave analysis (DPA) variables before and 1 minute after each injection.

Secondary outcome measures

The effect of anaesthesia on vascular tone and cardiac LV ejection fraction is assessed by digital photoplethysmography pulse wave analysis (DPA) variables before and after induction of anaesthesia.

Overall trial start date

01/08/2012

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women
2. Aged 18 years and over
3. Scheduled for termination of pregnancy in the first trimester by vacuum aspiration or curettage

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

51

Participant exclusion criteria

1.Gestational age above 12 weeks in viable pregnancies
2. Age less than 18 years
3. Do not understand Swedish
4. Serious cardiovascular disorders.

Recruitment start date

01/01/2013

Recruitment end date

01/06/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital
Malmö
20502
Sweden

Sponsor information

Organisation

Lund University

Sponsor details

Box 117
Lund
22100
Sweden
+46 46 222 0000
lu@lu.se

Sponsor type

University/education

Website

https://www.lu.se/

Organisation

Skåne University Hospital

Sponsor details

Diarium
Rådhus Skåne
Kristianstad
29189
Sweden
+46 40 331 000
region@skane.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Lunds Universitet

Alternative name(s)

Lund University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Region Skåne

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sofus Rabow (sofus.rabow@med.lu.se)

Intention to publish date

01/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes