Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000796482
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
17/06/2016
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Isothermic hydration : Effects on maternal body temperature and fetal outcomes
Scientific title
The effect of isothermic hydration on maternal body temperature and fetal outcomes for parturients undergoing cesarean section under spinal anesthesia
Secondary ID [1] 289296 0
none
Universal Trial Number (UTN)
U1111-1183-1466
Trial acronym
IHMBTFO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal anesthesia for cesarean section 298883 0
hypothermia 298884 0
Condition category
Condition code
Reproductive Health and Childbirth 298957 298957 0 0
Childbirth and postnatal care
Anaesthesiology 298958 298958 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
parturients undergoing cesarean section under spinal anesthesia will be randomly divided into two groups. control group will be hydrated with intravenous infusion of Lactated Ringer's solution 10ml/kg at room temperature and the study group will be hydrated with 10ml/kg intravenous Lactated Ringer's solution at 37 degrees celcius before the administration of spinal anesthesia. intravenous infusion continued with a rate of 4ml/min in each group till the end of surgery at 37 degrees celcius in study group and at 21 degrees celcius in the control group. the temperature of the study infusion solution was kept constant by the warming device.
Intervention code [1] 294848 0
Prevention
Intervention code [2] 294849 0
Treatment: Other
Comparator / control treatment
Intravenous infusion of the compator group will be at room temperature (21 degrees celcius).
Control group
Active

Outcomes
Primary outcome [1] 298429 0
Maternal body temperature, assessed with a digital thermometer at tympanic membrane.
Timepoint [1] 298429 0
basal body temperature of the parturient will be recorded on enterance to operation room. the body temperature of the parturient will than be recorded every minute till 10 minutes after spinal anesthesia. and every 5 minutes till 30 minutes or at the end of the operation
Secondary outcome [1] 324100 0
fetal cord blood gas pH value, assessed by cord blood gas analysis.
Timepoint [1] 324100 0
cord blood gas analysis of the newborn will be assessed immediately after delivery
Secondary outcome [2] 324685 0
APGAR scores
Timepoint [2] 324685 0
1 minute and 5 minutes following birth

Eligibility
Key inclusion criteria
parturients consenting to spinal anesthesia for cesarean section
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients rejecting spinal anesthesia or any contraindication for spinal anesthesia

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
following a pilot study, G*power statistical analysis program will be used to determine sample size for a 0,90 power with a statistical significance of 0,05.Kolmogorov-Smirnow and Shapiro Wilk tests, repeated measures ANOVA, friedman test, Tukey HSD, chi-square test, Spearman Rho correlation test will be used for statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
1/08/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7901 0
Turkey
State/province [1] 7901 0
kirsehir

Funding & Sponsors
Funding source category [1] 293676 0
Self funded/Unfunded
Name [1] 293676 0
mehmet canturk
Country [1] 293676 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] 292509 0
None
Name [1] 292509 0
Address [1] 292509 0
Country [1] 292509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295113 0
Turgut Ozal University Clinical Trials Ethics Committee
Ethics committee address [1] 295113 0
Ethics committee country [1] 295113 0
Date submitted for ethics approval [1] 295113 0
29/04/2016
Approval date [1] 295113 0
24/05/2016
Ethics approval number [1] 295113 0
99950669/116

Summary
Brief summary
preserving normothermia decreases morbidity and mortality in patients undergoing surgery. Intravenous infusion is usually provided by solutions present at operation theatre at room temperature and this condition provokes a decrease in body temperature and results in shivering. the decrease in maternal body temperature and resulting shivering and vasoconstriction may affect the fetal outcomes. in this study we are investigating if isothermic hydration will help to preserve maternal normothermia and improves fetal outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62838 0
Dr Mehmet Canturk
Address 62838 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k.40100 kirsehir
Country 62838 0
Turkey
Phone 62838 0
+905053574372
Fax 62838 0
Email 62838 0
[email protected]
Contact person for public queries
Name 62839 0
Dr Mehmet Canturk
Address 62839 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k.40100 kirsehir
Country 62839 0
Turkey
Phone 62839 0
+905053574372
Fax 62839 0
Email 62839 0
[email protected]
Contact person for scientific queries
Name 62840 0
Dr Mehmet Canturk
Address 62840 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3. Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k. 40100 kirsehir
Country 62840 0
Turkey
Phone 62840 0
+905053574372
Fax 62840 0
Email 62840 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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