Comparison of labor duration and short-term maternal-neonatal outcome in nulliparous women with vaginal delivery receiving intravenous normal saline and intravenous dextrose
This study aimed at comparing labor duration and short-term maternal-neonatal outcomes in nulliparous women with vaginal delivery receiving intravenous normal saline or dextrose. In this double-blind randomized clinical trial, 300 term nulliparae with singleton in active labor were recruited in Tabriz Alzahra Teaching Center during a 15-month period. These women were randomized in three well-matched 100-case groups receiving either intravenous normal saline as 125 ml/h , 5% dextrose as 125 ml/h , or nothing (controls). The primary outcome was total length of labor from onset of fluid administration. Maternal and neonatal outcomes were also analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008184592N1
Registration date:2011-06-01, 1390/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-01, 1390/03/11
Registrant information
Name
Tahereh Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+91 44021161
Email address
jpourhaji@iau-garmsar.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Siences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-01-15, 1389/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of labor duration and short-term maternal-neonatal outcome in nulliparous women with vaginal delivery receiving intravenous normal saline and intravenous dextrose
Public title
Efficacy of intravenous dextrose in progress of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term nulliparae women with singleton in active labor were candidates of vaginal delivery
Exclusion criteria: history of cardiovascular diseases, diabetes, or renal disease, prior c/s, induction, chorioamnionitis, pyelonephritis, other febrile disease at the onset of the study
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Faculty of medicine, Tabriz University of Medical Sciences - University Street
City
Tabriz
Postal code
Approval date
2010-11-10, 1389/08/19
Ethics committee reference number
5/4/6387 مورخه 89/8/19
Health conditions studied
1
Description of health condition studied
normal delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Labor duration
Timepoint
During delivery
Method of measurement
in minutes
Secondary outcomes
1
Description
Short-term maternal outcomes
Timepoint
One week after delivery to start labor
Method of measurement
Minte and Examination
2
Description
Short-term neonatal outcomes
Timepoint
One week after delivery to start labor
Method of measurement
Minute and Examination
Intervention groups
1
Description
control group: no ontervention
Category
Other
2
Description
Intravenous 5% dextrose as 125 ml/h in nulliparous women with vaginal delivery
Category
Treatment - Drugs
3
Description
Intravenous normal saline as 125 ml/h in nulliparous women with vaginal delivery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Alzahra Teaching Center
Full name of responsible person
Tahereh Alizadeh
Street address
Baghshomal crossroad
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Productivity Health Center of Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Sahhaf
Street address
University Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Productivity Health Center of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tahereh Alizadeh
Position
Assistant of Obstetrics & Gynecology
Other areas of specialty/work
Street address
No8 mohammadi alley abbasi street
City
Tabriz
Postal code
5156653191
Phone
+98 41 1685 4288
Fax
Email
Drpourhaji@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Sahhaf
Position
Obstetrics & Gynecology
Other areas of specialty/work
Street address
Faculty of medicine, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 914 114 5079
Fax
Email
Farnazsahhaf@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)