Effects of anaesthesia and oxytocin on maternal vascular tone
| ISRCTN | ISRCTN17860978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17860978 |
| Protocol serial number | 1 |
| Sponsors | Lund University, Skåne University Hospital |
| Funders | Lunds Universitet, Region Skåne |
- 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
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
Scientific
Lund University
Box 117
Lund
22100
Sweden
 ORCID ID |
0000-0001-7840-525X |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled single centre study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | Oxytocin, Propofol |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
20502
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | results | 22/11/2018 | 23/11/2020 | Yes | No |
| Participant information sheet | 26/03/2018 | 01/04/2019 | No | Yes | |
| Participant information sheet | 26/03/2018 | 01/04/2019 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
