Plain English Summary
Background and study aims
To conduct a comparative study of the effect of oxytocin dose on heart activity (ST-segment depression), during the operation, cesarean section under spinal anesthesia.
Who can participate?
Women aged 15 - 25 with singleton pregnancy undergoing an elective cesarean section
What does the study involve?
Participants will be randomised to receive one of two different doses of oxytocin during childbirth. The blood pressure and heart activity will be monitored.
What are the possible benefits and risks of participating?
There are no possible advantages and risks of participation
Where is the study run from?
Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”, Regional Perinatal Center, Russia
When is the study starting and how long is it expected to run for?
October 2016 to September 2018
Who is funding the study?
Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”, Regional Perinatal Center, Russia
Who is the main contact?
Evgeny Degtyaryov
dormicumtrade@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Mr Evgeny Degtyaryov
ORCID ID
http://orcid.org/0000-0002-7472-3733
Contact details
Politechnicheskaya str. 1
Blagoveshchensk
675000
Russian Federation
+7 89246751015
dormicumtrade@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1
Study information
Scientific title
Oxytocin dose effects on ST segment changes, arterial hypotension and blood loss volume in parturients of different ages during cesarean section
Acronym
Study hypothesis
Oxytocin (OT) is a first-line treatment for post-delivery bleeding prevention and treatment, but it is known to provide a range of other effects: parasympathetic neuromodulation, vasodilation, negative inotropic and chronotropic effects as a consequence of blood pressure (BP) drop. The hemodynamic effects of different dose of oxytocin and its influence on myocardium in different types of parturients remain unresolved. This prospective study was planned to assess the influence of the different dose of oxytocin on myocardial damage during cesarean section in primiparas of different ages.
Ethics approval
Approved 21/09/2016, Ethics Committee of the Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital” (Russia, 675006, Amur region, Blagoveshchensk, Gorky str., 95, Scientific Department; +8 (4162) 319 - 032; science.prorector@AmurSMA.su), ref: n/a
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Control of bleeding during cesarean section
Intervention
All patients were randomized into 2 arms according to OT dosing given by various clinical guidelines: 5 IU and 10 IU. The rate of intravenous drip of oxytocin in all puerperas was equal to 0.5 IU/min. the Introduction of additional doses of OR other drugs with uterotonic effect was not carried out.
Arterial hypotension was noted as systolic blood pressure below 80 mm Hg, lasted less than 5 min. and was controlled with IV microfluidic infusion of noradrenalin solution with the rate of 0.03 µg/kg/min.
ST-segment status was analyzed using BeneView T6 patient monitor (Mindray, China). Clinically significant ST-segment depression was reported if ST fell more than 0.5 mm below the isoelectric line. ST-segment depression was reversible and did not last more than 15 min. All patients were randomized into 2 arms according to oxytocin dosing given by various clinical guidelines: 5 IU and 10 IU.
The surgeon assessed oxytocin uterotonic effects via palpation during cesarean section and within 2 hours afterwards.
Randomization algorithm included patient randomization into 2 arms using a random number generator and closed envelope method. Also in each randomized arm patients were stratified by age into 2 subgroups: young patients (below 18) and ones of optimal reproductive age (18 years and older).
Intervention type
Drug
Phase
Not Applicable
Drug names
Oxytocin
Primary outcome measure
1. Intraoperative ST segment depression measured using intraoperative ECG monitoring (II standard lead), ST segment depression (mm); ST segment status was analyzed using BeneView T6 patient monitor (Mindray, China).
2. Intraoperative hypotension: Arterial hypotension was noted as systolic blood pressure below 80 mm Hg, lasted less than 5 min. and was controlled with IV microfluidic infusion of noradrenalin solution with the rate of 0.03 µg/kg/min.
Secondary outcome measures
Intraoperative blood loss was determined using indirect visual method by a team of MD’s, which included: a surgeon (obstetrician-gynecologist, highest Qualification Grade), an assistant surgeon and an anesthesiologist-intensivist (highest Qualification Grade).
Overall trial start date
21/09/2016
Overall trial end date
30/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Full-term singleton pregnancy
2. Elective cesarean section
3. Age of 15 to 25 years inclusive
4. Body mass index (BMI) below 25 kg/m²
5. Pregnancy and labor parity - 1
Participant type
Healthy volunteer
Age group
Mixed
Gender
Female
Target number of participants
45
Total final enrolment
45
Participant exclusion criteria
1. Severe extragenital diseases
2. Preeclampsia and eclampsia
Recruitment start date
01/10/2016
Recruitment end date
30/09/2018
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”, Regional Perinatal Center
Voronkova str. 26
Blagoveshchensk
675000
Russian Federation
Sponsor information
Organisation
Federal state budget educational institution higher education «Amur State Medical Academy» of the Ministry of Health of the Russian Federation.
Sponsor details
Gorkogo str. 95
Blagoveschensk
675000
Russian Federation
+7 84162319007
AmurSMA@AmurSMA.su
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”, Regional Perinatal Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
PLOS ONE
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/03/2020
Participant level data
Other
Basic results (scientific)
Publication list