Maternal hypotension is the commonest serious problem following spinal anesthesia for Cesarean section,with an incidence up to 83%.1 Volume
preloading has been recommended for prevention of spinal-induced hypotension in this situation. However, controversy regarding the different preloading regimens
remains unresolved.Recent studies have questioned the advantage of
preloading with crystalloid in the prevention of spinal linduced hypotension in patients undergoing Cesarean section.We designed a randomized double-blind study to compare the incidence of hypotension in women undergoing elective cesarean delivery under spinal anesthesia who received 500 mL of colloid solution administered as a preload or coload versus a crystalloid solution adminstered as a preload.
In this double-blind study, 105 patients were randomly assigned to receive a preload of 500 mL of hydroxyethyl starch (n = 35) or normal saline (n = 35) over a period of 15–20 min before initiation of spinal anesthesia or an identical fluid bolus of hydroxyethyl starch starting at the time of identification of cerebrospinal fluid (n =35) .perioperative maternal vital signs (Blood pressure, heart rate and arterial oxygen saturation) and also neonatal outcome including 1st and 5th apgar scores and arterial blood gas analyses are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307215381N6
Registration date:2013-08-06, 1392/05/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-06, 1392/05/15
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of crystalloid or colloid on maternal blood pressure after spinal anesthesia in cesarean section.
Public title
The effects of crystalloid or colloid on maternal blood pressure after spinal anesthesia in cesarean section.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:18 to 35 years pregnant women candided for cesarean secton with ASA class I,II; parturients more than 37-week gestation.
Exclusion criteria: Hypertension BP>140/90; DM;weight >100 kg; multiple gestation; Cardiovascular and cerbrovascular disease; Significant fetal abnormalities; contraindication of spinal anesthesia; mothers who are at the start of active phase of labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Babol University of Medical Sciences
Street address
Daneshgah Sq, Ganjafrooz Ave
City
Babol
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
2824/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Cesarean Section
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline BP before Spinal anesthesia and every 3 minutes control until the end of surgery
Method of measurement
Non invasive BP Cuff
2
Description
PH of umbilical artery
Timepoint
Immediatly after birth
Method of measurement
ABG
Secondary outcomes
1
Description
Base excess
Timepoint
Base excess
Method of measurement
ABG
2
Description
Lactate of umbilical artery
Timepoint
Immediatly after birth
Method of measurement
ABG
3
Description
Infant Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar Score
4
Description
Heart rate
Timepoint
Before spinal anesthesia until the end of surgery every3 minutes
Method of measurement
pulse counting
Intervention groups
1
Description
Intervention 1: patients receive 500 mL of 6% hetastarch intravenously slowly before spinal anesthesia
Category
Prevention
2
Description
Intervention 2: patients receive 500 mL of 6% hetastarch intravenously as quickly as possible immediately after spinal anesthesia.
Category
Prevention
3
Description
Control group: patients receive 500 mL of ringer intravenously slowly before spinal anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Nadia Banihashem
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Daneshgah Square, Ganjafrooz Avenue, Vice-chancellor Of Research
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research Babol University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Freshteh Naziri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
freshteh.naziri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)