Background: Restriction received food and fluid in women during Labor has a side effect on uterine contractions. The aim of the present study was determined the effect of increased intravenous fluids the duration and type of delivery in nulliparous women.Methods: This is a randomized, single-blind clinical trial study that was performed at the Ilam Mustafa Khomeini Hospital of Ilam, Iran in 2010. Through a randomized single blind controlled clinical trial, 120 full-term, nulliparous women with uncomplicated singleton pregnancies were randomly assigned to receive lactated ringers at 60,120 and 240 ml/ hour (IV fluid group) throughout active labor or usual care.The groups were matched and all women were allowed unrestricted oral fluids consumption. The process of labor, cervical dilatation and descent were recorded after each examination by trained midwives . Type of delivery was recorded . After collecting, the results were analyzed by spss software. Inclusion criteria:Iranian nationality;35-18 years of age ;primiparous, singleton pregnancy;gestational age38-40;without CPD; optimal care during pregnancy;blood pressure less than 140/90 mmHg; body mass index 19/8-26(kg m) before pregnancy;beginning of the active phase of labor with cervical dilatation 4 cm ; intact of membran ;estimated fetal weight less than 4000 grams; Excluding criteria : Polyhydramnios;abnormal presentation;preeclampsia;pyelonephritis
;any other febrile illnesses in the last 48 hours;known medical conditions before and during pregnancy such as asthma; cardiovascular disease;diabetes;kidney disease or cratinin more than 1 at the admission time; disorders of gastroenteritis during the last 48 hours; symptoms of dehydration in the last 48 hours
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105256575N2
Registration date:2011-07-16, 1390/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-16, 1390/04/25
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ilam University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of increased intravenous hydration on duration of labor and type of delivery
Public title
The effect of increased intravenous hydration on the course and out come of labor in nulliparous women during 1387.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Iranian nationality;35-18 years of age ;primiparous, singleton pregnancy;gestational age38-40;without CPD; optimal care during pregnancy;blood pressure less than 140/90 mmHg; body mass index 19/8-26(kg m) before pregnancy;beginning of the active phase of labor with cervical dilatation 4 cm ; intact of membran ;estimated fetal weight less than 4000 grams; Excluding criteria : Polyhydramnios;abnormal presentation;preeclampsia;pyelonephritis
;any other febrile illnesses in the last 48 hours;known medical conditions before and during pregnancy such as asthma; cardiovascular disease;diabetes;kidney disease or cratinin more than 1 at the admission time; disorders of gastroenteritis during the last 48 hours; symptoms of dehydration in the last 48 hours
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Ilam, Iran
City
Ilam
Postal code
Approval date
2009-05-17, 1388/02/27
Ethics committee reference number
1803/40/22
Health conditions studied
1
Description of health condition studied
Increased Intravenous Hydration of Nulliparous in Labor
ICD-10 code
o80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
duration of labor
Timepoint
start of active phase to 24h after delivery
Method of measurement
duration of labora ccording to minute
Secondary outcomes
1
Description
type of delivery
Timepoint
type of delivery
Method of measurement
type of delivery vaginal or cesarean
Intervention groups
1
Description
The second, groupreceived 60 ml of lactated Ringer’s solution IV per hour
Category
Treatment - Drugs
2
Description
The first group (usual care) received lactated Ringer’s solution IV per hour whenever they needed based on obstetrical condition.
Category
Treatment - Drugs
3
Description
The third group received 120 ml of lactated Ringer’s solution IV per hour
Category
Treatment - Drugs
4
Description
The fourth groupreceived 240 ml of lactated Ringer’s solution IV per hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mustafa Khomeini hospital,Ilam
Full name of responsible person
BA of Midwifery
Street address
Mustafa Khomeini hospital,Ilam , Iran
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ilam University of Medical Sciences
Full name of responsible person
Dr Afra Khosravi research manager of research, Ilam University of Medical Sciences
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
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, Ilam 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
Department of Midwifery,Faculty of Nursing and Midwifery,Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Ilam
City
Ilam
Postal code
Phone
+98 918 342 0061
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of nursing and Midwifery, Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Department of nursing and Midwifery, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 918 342 0061
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Midwifery,Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc
Other areas of specialty/work
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)