Background and Objectives: Lack of information regarding biochemical changes in women during labor and it’s outcomes on maternal and neonatal health was the main reason for conducting the trial. Our objectives were to determine the effect of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes.
Design: A parallel prospective randomized controlled trial.
Setting, and Conducts: The study conducted between September 2008 and April 2009, at the University Affiliated Teaching Hospital in Gonabad.
Participants: 177 women were randomly assigned to an intervention group (N=97) or control group (N=90).
Inclusion and Exclusion Criteria: Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3-4 cm. Exclusion criteria were cesarean section; fast labor; and fetal compromise.
Interventions: Women generally were unaware of group allocation. Women in the carbohydrate group have been advised to consume based on their own preferences, three medium dates with 110 ml water; or three dates with 110 ml light tea without sugar; or 110 ml industrial orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Women assigned to the control group were asked to consume just water as routine practice.
Results: Differences between duration of the active phase of labor was assessed as primary outcome measure. Other maternal and neonatal outcomes were the frequency of vomiting, type of delivery, need for augmentation of labor, analgesia, and neonatal outcomes that were considered as secondary outcome measures
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105155805N2
Registration date:2011-05-31, 1390/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Parvaneh Yavari
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2738
Email address
pyavari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Faculty of Nursing & Midwifery, Tehran University of Medical sciences.
Dates: 05/01/2008-14/69/250/ص
Expected recruitment start date
2008-03-04, 1386/12/14
Expected recruitment end date
2008-06-14, 1387/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Controlled Trial to Compare the Effect of Oral Carbohydrate Intake or Fasting in Low-risk Women during Labor Progress
Public title
Oral carbohydrate intake on labor progress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion and Exclusion Criteria: Inclusion criteria were low-risk women; singleton cephalic presentation; and cervical dilatation 3-4 cm. Exclusion criteria were cesarean section; fast labor; and fetal compromise
Age
From 19 years old to 33 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
187
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No.106, 6th Floor, Central Bldg. for TUMS , Ghods St.,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2008-01-05, 1386/10/15
Ethics committee reference number
14/69/250/ص
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
080
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Duration of active phase of labor
Timepoint
From dilatation 3-4 Cm to the complete dilatation
Method of measurement
Every 5 minutes
Secondary outcomes
1
Description
Frequency and volume of vomiting
Timepoint
Every 5 minutes
Method of measurement
By mesaurment glass based on miiliter and recheck with syringe 10 ml
2
Description
Neonate heart rates
Timepoint
First and second stage of labor
Method of measurement
By External electronic fetal heart monitoring
3
Description
Apgar scores
Timepoint
One minute and five minutes after birth
Method of measurement
Standard method based on minute
4
Description
Birth weight
Timepoint
After Birth
Method of measurement
The Neonate Scale was tested for accuracy with 100 gram weight
Intervention groups
1
Description
The women were randomly assigned to two groups. Women generally were unaware of each other groups. Women in the carbohydrate group were advised to consume three medium dates with 110 ml water; or three dates with 110 ml light tea without sugar; or 110 ml orange juice drink based on their preferences. The protocol is only run once but women ate and drank gradually before second stage of labor.
Category
Treatment - Drugs
2
Description
Women assigned to the control group were asked to consume just water as routine practice..
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Roghayeh Rahmani, roghaiehrahmany@yahoo.com
Street address
Gonabad University of Medical Sciences
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Sciences Vice Chancellor for Reasearch, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr. Akbar Fotohi
Street address
No.106, 6th Floor, Central Bldg. for TUMS , Ghods St.,Keshavarz Blvd.
City
Tehran
Grant name
بودجه معمول جهت تحصیلات تکمیلی
Grant code / Reference number
Dates: 05/01/2008-14/69/250/ص
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences Vice Chancellor for Reasearch, Tehran University of Medical Sciences (TUMS)
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
Faculty of Nursing and Midwifery,Tehran University of Medical Sciences