Effects of anaesthesia and oxytocin on maternal vascular tone

ISRCTN	ISRCTN17860978
DOI	https://doi.org/10.1186/ISRCTN17860978
Secondary identifying numbers	1

Submission date: 14/03/2018
Registration date: 16/05/2018
Last edited: 23/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Per Olofsson
Scientific

Lund University
Box 117
Lund
22100
Sweden

ORCID ID	0000-0001-7840-525X

Study information

Study design	Randomised double-blind placebo-controlled single centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	ISRCTN17860978_PIS_26Mar18_abort.pdf
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
Study objectives	Oxytocin decreases vascular tone and elevates cardiac output in first trimester pregnacy
Ethics approval(s)	Regional Research Ethics Committee in Lund, 13/12/2012, ref: 2012/649
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)	Oxytocin, Propofol
Primary outcome measure	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 study start date	01/08/2012
Completion date	01/01/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	51
Total final enrolment	51
Key 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
Key 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.
Date of first enrolment	01/01/2013
Date of final enrolment	01/06/2013

Locations

Countries of recruitment

Sweden

Study participating centre

Skåne University Hospital

Malmö
20502
Sweden

Sponsor information

Lund University
University/education

Box 117
Lund
22100
Sweden

Phone	+46 46 222 0000
Email	lu@lu.se
Website	https://www.lu.se/

Skåne University Hospital
Hospital/treatment centre

Diarium
Rådhus Skåne
Kristianstad
29189
Sweden

Phone	+46 40 331 000
Email	region@skane.se

Funders

Funder type

Government

Lunds Universitet
Government organisation / Universities (academic only)

Alternative name(s): Lund University, Universitas Lundensis, Universitas Gothorum Carolina, Royal Caroline Academy, Regia Academia Carolina, Lund University | Lund, Sweden | LU, Lunds universitet, LU
Location: Sweden

Region Skåne

No information available

Results and Publications

Intention to publish date	01/06/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet		26/03/2018	01/04/2019	No	Yes
Participant information sheet		26/03/2018	01/04/2019	No	Yes
Results article	results	22/11/2018	23/11/2020	Yes	No

Additional files

ISRCTN17860978_PIS_26Mar18_abort.pdf: Uploaded 01/04/2019
ISRCTN17860978_PIS-26mar18_missfall.pdf: Uploaded 01/04/2019

Editorial Notes

23/11/2020: Publication reference added.
24/04/2019: Internal review.
01/04/2019: The participant information sheet has been uploaded.