Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000739213
Ethics application status
Approved
Date submitted
25/04/2018
Date registered
3/05/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of isothermic coloading with crystalloids during spinal anesthesia for cesarean delivery on maternal vital signs and fetal outcomes
Scientific title
Effects of isothermic coloading with crystalloids during spinal anesthesia for cesarean delivery on maternal vital signs and fetal outcomes
Secondary ID [1] 294717 0
none
Universal Trial Number (UTN)
U1111-1212-9080
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
spinal anesthesia during cesarean section 307596 0
hypotension 307597 0
bradycardia 307598 0
hypoxemia 307599 0
Condition category
Condition code
Anaesthesiology 306655 306655 0 0
Other anaesthesiology
Reproductive Health and Childbirth 306656 306656 0 0
Childbirth and postnatal care
Cardiovascular 306674 306674 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
pregnant patients undergoing cesarean section under spinal anesthesia will be randomly allocated into two groups. Control group will be hydrated with single dose 15ml/kg of intravenous crystalloid solution at room temperature and study group will be hydrated with single dose 15ml/kg of intravenous crystalloid solution at body temperature (37 degrees celsius) by the anesthesia nurse of the operation room following administration of spinal anesthesia (following the removal of spinal needle in 5 minutes). The temperature of the infusion fluid will be kept constant using a warming device.
Intervention code [1] 301010 0
Prevention
Intervention code [2] 301011 0
Treatment: Other
Comparator / control treatment
comparator group will receive intravenous co-loading at room temperature (21 degrees celsius).
Control group
Active

Outcomes
Primary outcome [1] 305656 0
maternal hypotension, assessed with a non invasive blood pressure from the left arm measured at the acceptance of patient to operation room and every minute for 10 minutes following induction of spinal anaesthesia [primary timepoint] then every 5 minutes till 30 minutes or at the end of surgery. hypotension is defined as a 20% decrease of basal blood pressure.
Timepoint [1] 305656 0
basal blood pressure will be measured after the patient is accepted to the operation room. blood pressure will than be measured every minute for 10 minutes following induction of spinal anaesthesia [primary timepoint] then every 5 minutes till 30 minutes or at the end of surgery.
Primary outcome [2] 305657 0
maternal bradycardia, assessed with the electrocardiography on the monitor. bradycardia is accepted as a heart rate lower than 50 beats per minute.
Timepoint [2] 305657 0
heart rate will be monitorized beginning with the acceptance of the parturient to the operation room until the end of surgery.
Secondary outcome [1] 346054 0
fetal apgar score (an index used to evaluate the condition of a newborn infant based on a range of 0, 1, 2 for each of the five characteristics of color, heart rate, response to stimulation of the sole of the foot, muscle tone, and respiration with 10 being a perfect score)
Timepoint [1] 346054 0
assessed by a pediatrician at first and fifth minutes after birth.

Eligibility
Key inclusion criteria
parturients scheduled for elective cesarean section under spinal anesthesia with term singleton uncomplicated pregnancies.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
parturients that reject spinal anesthesia or that have any contraindication for spinal anesthesia. Parturients that refuse to be involved in the study. Complicated pregnancies or any history of fetal abnormalities. Emergency cases.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated sequence is used for sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM SPSS package program will be used to assess data. Shapiro Wilk test, repeated measures ANOVA, friedman test, Tukey HSD, chi-square test will be used to analyse data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
1/08/2018
Actual
17/07/2018
Date of last data collection
Anticipated
1/08/2018
Actual
17/07/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 10353 0
Turkey
State/province [1] 10353 0
kirsehir

Funding & Sponsors
Funding source category [1] 299324 0
Hospital
Name [1] 299324 0
Ahi Evran University Training and Research Hospital
Country [1] 299324 0
Turkey
Primary sponsor type
Individual
Name
mehmet canturk
Address
Medical doctor at government hospital
asikpasa mahallesi
sehit ahmet dogangun caddesi
caglar apartmani
30/8
merkez/kirsehir/Turkey p.k.40100
Country
Turkey
Secondary sponsor category [1] 298592 0
None
Name [1] 298592 0
Address [1] 298592 0
Country [1] 298592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300231 0
Ahi Evran Üniversitesi Tip Fakultesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 300231 0
Ahi Evran Universitesi Tip Fakultesi Bagbasi yerleskesi 40100 merkez kirsehir
Ethics committee country [1] 300231 0
Turkey
Date submitted for ethics approval [1] 300231 0
26/03/2018
Approval date [1] 300231 0
10/04/2018
Ethics approval number [1] 300231 0
2018-07/74

Summary
Brief summary
hypotension is a common occurance in parturients undergoing cesarean section with spinal anesthesia. several modalities have been tested to prevent or decrease the degree of hypotension in paturients during cesarean section under spinal anesthesia. In the recent studies, coloading with crystalloids is reported to be superior than preloading with crystalloids. The current study is conducted to determine the effect of isothermic coloading with crystalloid fluid on maternal vital signs and fetal apgar scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82994 0
Dr mehmet canturk
Address 82994 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 40200 merkez kirsehir
Country 82994 0
Turkey
Phone 82994 0
+905053574372
Fax 82994 0
Email 82994 0
[email protected]
Contact person for public queries
Name 82995 0
Dr mehmet canturk
Address 82995 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 40200 merkez kirsehir
Country 82995 0
Turkey
Phone 82995 0
+905053574372
Fax 82995 0
Email 82995 0
[email protected]
Contact person for scientific queries
Name 82996 0
Dr mehmet canturk
Address 82996 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 40200 merkez kirsehir
Country 82996 0
Turkey
Phone 82996 0
+905053574372
Fax 82996 0
Email 82996 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of isothermic crystalloid coload on maternal hypotension and fetal outcomes during spinal anesthesia for cesarean section: A randomized controlled trial.2019https://dx.doi.org/10.1016/j.tjog.2019.01.028
N.B. These documents automatically identified may not have been verified by the study sponsor.