ISRCTN ISRCTN28030442
DOI https://doi.org/10.1186/ISRCTN28030442
Secondary identifying numbers 1
Submission date
02/10/2019
Registration date
03/10/2019
Last edited
03/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Evgeny Degtyaryov
Public

Politechnicheskaya str. 1
Blagoveshchensk
675000
Russian Federation

ORCiD logoORCID ID 0000-0002-7472-3733
Phone +7 89246751015
Email dormicumtrade@gmail.com

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOxytocin dose effects on ST segment changes, arterial hypotension and blood loss volume in parturients of different ages during cesarean section
Study objectivesOxytocin (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(s)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
Health condition(s) or problem(s) studiedControl of bleeding during cesarean section
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oxytocin
Primary outcome measure1. 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 measuresIntraoperative 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 study start date21/09/2016
Completion date30/11/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexFemale
Target number of participants45
Total final enrolment45
Key inclusion criteria1. 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
Key exclusion criteria1. Severe extragenital diseases
2. Preeclampsia and eclampsia
Date of first enrolment01/10/2016
Date of final enrolment30/09/2018

Locations

Countries of recruitment

  • Russian Federation

Study 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

Federal state budget educational institution higher education «Amur State Medical Academy» of the Ministry of Health of the Russian Federation.
University/education

Gorkogo str. 95
Blagoveschensk
675000
Russian Federation

Phone +7 84162319007
Email AmurSMA@AmurSMA.su
ROR logo "ROR" https://ror.org/05x21mt76

Funders

Funder type

Hospital/treatment centre

Autonomous Public Health Care Institution of Amur Region “Amur Regional Clinical Hospital”, Regional Perinatal Center

No information available

Results and Publications

Intention to publish date01/03/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPLOS ONE
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

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”