Objective: Comparison of normal saline solution and dextrose saline infusion on duration of active phase and second stage of labor in nulliparous women. Materials and Methods: In this randomized clinical trial 150 eligible pregnant women presenting with labor pain were randomly divided into two groups. Inclusion criteria: gestational age 36 weeks or more; nulliparity; singleton; cephalic presentation;cervical dilatation 3-5 cm (active phase of labor). Exclusion criteria : diabetes; preeclampsia; cardiac or kidney diseases; intrauterian fetal death; chorioamnionitis; meconium in amniotic fluid; fetal distress. One group received normal saline and the other dextrose saline 5% administrated at a rate of 120cc/h. Initial vaginal examination and onset of serum administration was recorded for each patient. Thereafter examination was done every hour and the results were recorded.
If the dilatation progress was less than 1.2 cm per hour, uterine contractions was assessed and if inappropriate, oxytocin at a dose of 10unit/liter serum was administrated. In case of no change in dilatation for 2 hours or descend for 1 hour the patient was scheduled for c/s. If labor progressed at a normal pace,the time of complete dilation , duration of second stage of labor , Apgar scores were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209253025N3
Registration date:2014-02-21, 1392/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-21, 1392/12/02
Registrant information
Name
Farideh Movahed
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 0307
Email address
fmovahed@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University Of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of normal saline solution and dextrose saline infusion on duration of active phase and second stage of labor in nulliparous women
Public title
Comparison of normal saline solution and dextrose saline infusion on duration of active phase and second stage of labor in nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 36 weeks or more; nulliparity; singleton; cephalic presentation; cervical dilatation 3-5 cm (active phase of labor).
Exclusion criteria: diabetes; preeclampsia; cardiac or kidney diseases; intrauterian fetal death; chorioamnionitis; meconium in amniotic fluid; fetal distress.
Age
From 16 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Qazvin University Of Medical Sciences
Street address
Bahonar Blvd
City
Qazvin
Postal code
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
7777/20/28
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
Single spo
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Duration of active phase of labor
Timepoint
Vaginal examination : bigining of active phase (cervical dilatation 3-5 cm ) , time of full dilatation (10 cm)
Method of measurement
Minute
2
Description
Duration of second phase of labor
Timepoint
Time of full dilatation until expulsion of fetus
Method of measurement
Minute
Secondary outcomes
1
Description
Apgar score
Timepoint
First Minute, minute 5 after birth
Method of measurement
Apgar tab
Intervention groups
1
Description
Infusion of normal salin 120 cc/h in active phase of labor
Category
Treatment - Drugs
2
Description
Infusion of dexterose saline 5% 120cc/h in active phase of labor
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Farideh Movahed
Street address
Kosar Hospita, Taleghni street, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor For Research of Qazvin University of Medical Science
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor For Research of Qazvin University of Medical Science
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
Qazvin University of Medical Science
Full name of responsible person
Dr Farideh Movahed
Position
Obstetrician & Gynecologist / Associated professor
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
fmovahed@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr farideh Movahed
Position
Obstetrician & Gynecologist / Associated professor
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
fmovahed@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)