Cesarean Section ComplicationsNCT04230525
Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section
An observational study of Cesarean Section Complications, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- non invasive whole body bioimpedence system
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2020to 10 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Adult
Study population: Emergency or elective cesarean patients, which are between 18-45 years of age
Who may be able to join
- Must be scheduled for elective or emergency cesarean section
Who cannot join
- History of cardiac surgery, and advanced cardiac valvular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
aygen türkmen, MD.prof., +902129453000, aygenturkmen@hotmail.com
About this study
Official title: Noninvasive Evaluation of Hemodynamics by Using Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section
Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions.
Read the detailed description
Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions. Under general anesthesia, measuring the hemodynamic changes with the method of non-invasive whole-body bioimpedance system during C/S.
Detection of in which phase of operations the potential changes densify and differences between urgent and elective conditions non invasively.
- Conditions
- Cesarean Section Complications
- Being tested
- non invasive whole body bioimpedence system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive whole body bioimpedence systemDiagnostic test
Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. The whole-body bioimpedance method will be used to monitör the hemodynamic changes non invasively. This method can evaluate such as cardiac output, cardiac index, stroke volüme, stroke index, stroke volüme variations, cardiac reserve, etc. Parameters with a completely noninvasive method by using only electrots. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.
| Study group | Role | What they receive |
|---|---|---|
| Bioimpedence | Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. Receives: Diagnostic Test: non invasive whole body bioimpedence system |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP
The difference in mean arterial pressure during the cesarean section between elective and emergency ceasreansection subjects
Measured: 1, 5, 15, and 30 minutes following the induction of the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start5 Mar 2020
- Primary completion5 Jun 2020
- Study completion10 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zuhal Çavuş, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230525
- Sponsor's protocol ID
- Zuhal1
- Status last verified
- Jun 2020
- First submitted
- 13 Jan 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Evaluation of Hemodynamics by Using Body Impedance Method in Patients Undergoing Urgent and Elective Cesarian Section
- ClinicalTrials.gov ID
- NCT04230525
- Acronym / sponsor ID
- Zuhal1
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions.
Detailed description
Independent form anesthetic methods, during C/S, considering both maternal and fetal conditions, some crucial hemodynamic changes can appear and can be claimed non invasively with the whole body bioimpedance. In this research, any kind of hemodynamic difference between this method and urgent or elective C/S case will be detected and the clinic pursuit can be developed creating an advantage in favor of both maternal and fetal conditions. Under general anesthesia, measuring the hemodynamic changes with the method of non-invasive whole-body bioimpedance system during C/S.
Detection of in which phase of operations the potential changes densify and differences between urgent and elective conditions non invasively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioimpedence | – | Diagnostic Test: non invasive whole body bioimpedence systemNoninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Emergency or elective cesarean patients, which are between 18-45 years of age
Key inclusion criteria (1 listed)
- Must be scheduled for elective or emergency cesarean section
Key exclusion criteria (1 listed)
- History of cardiac surgery, and advanced cardiac valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive whole body bioimpedence systemNoninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. The whole-body bioimpedance method will be used to monitör the hemodynamic changes non invasively. This method can evaluate such as cardiac output, cardiac index, stroke volüme, stroke index, stroke volüme variations, cardiac reserve, etc. Parameters with a completely noninvasive method by using only electrots. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists. | Diagnostic test | Bioimpedence |
Primary outcome
MAP
Time frame: 1, 5, 15, and 30 minutes following the induction of the anesthesia
The difference in mean arterial pressure during the cesarean section between elective and emergency ceasreansection subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zuhal Cavus, MD (+902124041500, zuhalcavus74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP (time frame: 1, 5, 15, and 30 minutes following the induction of the anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.