Oxytocin dose effects during cesarean section
| 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
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
Public
Politechnicheskaya str. 1
Blagoveshchensk
675000
Russian Federation
 ORCID ID |
0000-0002-7472-3733 |
|---|---|
| Phone | +7 89246751015 |
| dormicumtrade@gmail.com |
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oxytocin dose effects on ST segment changes, arterial hypotension and blood loss volume in parturients of different ages during cesarean section |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 21/09/2016 |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 45 |
| Total final enrolment | 45 |
| Key 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 |
| Key exclusion criteria | 1. Severe extragenital diseases 2. Preeclampsia and eclampsia |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 30/09/2018 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Blagoveshchensk
675000
Russian Federation
Sponsor information
University/education
Gorkogo str. 95
Blagoveschensk
675000
Russian Federation
| Phone | +7 84162319007 |
|---|---|
| AmurSMA@AmurSMA.su | |
"ROR" |
https://ror.org/05x21mt76 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | PLOS ONE |
| IPD sharing plan | All 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”
