Condition category
Pregnancy and Childbirth
Date applied
02/10/2019
Date assigned
03/10/2019
Last edited
03/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Publication citations

Additional files

Editorial Notes

03/10/2019: Trial’s existence confirmed by Ethics Committee of the Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”