This clinical trial was performed in 2015 on 66 pregnant women hospitalized in Fatemieh hospital of hamedan, Iran. This study was performed aimed to assess the Relationship between serum and salivary biomarkers of oxidative stress during delivery and neonatal outcome. Inclusion criteria is The absence of acute and chronic complications of pregnancy and labor, singleton pregnancy full term pregnancy, lack of indications for cesarean and Exclusion criteria is the unwillingness of parents to continue to participate in the study.
The patients were divided into two groups of Painless delivery and delivery with natural pain. When the cervix dilated 4-5 cm , in intervention group, a bolus of 17 mg of 0.125% bupivacaine injected in spinal space plus 10 microgram sufentanil (2cc) with 2 mg of bupivacaine injected epidural space. Before delivery, 5 ml of mother blood and 5 ml of mother saliva will be taken and after delivery ,5 ml of placenta blood will be taken too. The samples will be sent to the laboratory and then The index of total antioxidant, catalase enzymes and thiol groups will be measured.
.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502266888N7
Registration date:2015-05-16, 1394/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relationship between serum and salivary biomarkers of oxidative stress during delivery and neonatal outcome in Fatemieh
Public title
The levels of oxidative stress biomarkers during labor
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: The absence of acute and chronic complications of pregnancy and labor, singleton pregnancy full term pregnancy, lack of indications for cesarean Exclusion criteria: the unwillingness of parents to continue to participate in the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2015-01-12, 1393/10/22
Ethics committee reference number
5148/1/35/16/پ
Health conditions studied
1
Description of health condition studied
Biomarkers of oxidative stress during labor
ICD-10 code
P00-P96
ICD-10 code description
Certain conditions originating in the perinatal period
Primary outcomes
1
Description
total Antioxidant capacity
Timepoint
After the intervention at 8-9 cm dilatation
Method of measurement
In umol / ml by using FRAP
2
Description
Catalase enzyme
Timepoint
After the intervention at 8-9 cm dilatation
Method of measurement
In umol / ml by using TBA
3
Description
Thiol groups
Timepoint
After the intervention at 8-9 cm dilatation
Method of measurement
In MMol by using laboratory techniques
Secondary outcomes
1
Description
Hypotension
Timepoint
Continuous monitoring of blood pressure after the intervention up to 2 hours after delivery
Method of measurement
pressure on the Mm Hg using a sphygmomanometer
2
Description
hyperthermia
Timepoint
Continuous monitoring of body temperature after intervention Up to 2 hours postpartum
Method of measurement
body temperature in Mm Hg using an oral thermometer
3
Description
Increasing duration of delivery
Timepoint
Every two hours after the intervention
Method of measurement
Partograghy form
Intervention groups
1
Description
Control group: Usual care or no intervention will receive
Category
Diagnosis
2
Description
Group Intervention: The intervention consisted of a combination of local anesthesia administered during the active phase of labor and 3-4 cm cervical dilatation. we used of Marcaine with a concentration of ./125 The rate of 17 mg for spinal anesthesia and the solution sufentanil 1/7 cc & Marcaine with 2 mg used for spinal anesthesia
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital of Hamadan
Full name of responsible person
Fatemeh Shobeiri
Street address
Kermanshah Street, Pasdaran Avenue, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Heidar Tavilani
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
vc_research@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
fshobeiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)