Comparing parenteral 5% dextrose, ringer and oral intake on the duration of labor stages in nulliparous women: A double- blinded randomized, controlled trial
The present study aims to determine the effects of intravenous dextrose 5%, Ringer and oral fluids on the courses of labor. This double-blind (investigators-participants) randomized controlled trial will be conducted in three groups of 201 nulliparous women referring to Mahabad Emam-Khomeini Hospital. Eligibility criteria will include: being nulliparous, term pregnancy (gestational age 38-41 weeks), singleton pregnancy with cephalic presentation, spontaneous onset of delivery and in active phase of labor. Exclusion criteria include the following: women with labor induction, the ones with high risk pregnancy, and intrauterine fetal death. Intervention: The women in the first group will receive intravenous dextrose 5% while the other two groups will respectively receive Ringer with oral fluids and oral fluids only. The serum intravenous infusion rate will be 125 ml/h since admission to delivery room until 2 hours postpartum. The primary outcomes: duration of first, second and third stages of labor. The secondary outcomes: maternal (type of delivery, frequency of oxytocin administration, frequency of prolonged labor) and neonatal (Apgar scores) outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602213027N35
Registration date:2016-03-13, 1394/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing parenteral 5% dextrose, ringer and oral intake on the duration of labor stages in nulliparous women: A double- blinded randomized, controlled trial
Public title
Effects of intravenous dextrose 5% on delivery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being nulliparous, ages 18-35, gestational age (38-41 weeks), singleton pregnancy with cephalic presentation, onset of first stage of labor and 3-4 cm dilated, spontaneous onset of labor, maternal first trimester body mass index 18.5 <BMI<24.9 kg/m2, normal maternal pelvis (according to the experts and the researchers examinations), clinical and ultrasound prediction of no fetal macrosomia (weight more than 4.5 kg). Exclusion criteria: women with labor induction (indications of induction of labor such as prolonged rupture of membranes (over 18 h), gestational hypertension, nonreassuring fetal status, diabetes or preeclampsia), high risk pregnancies (gestational diabetes, preeclampsia, heart or kidney diseases, IUGR, detachment or placenta praevia,. ..) evidence of chorioamnionitis (maternal fever over 38oc) and fetal distress (abnormal NST), intrauterine fetal death, use of epidural
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
201
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 universityof medical sciences
Street address
Central building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
TBZMED.REC.1394.972
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
XV
ICD-10 code description
O80-O84
Primary outcomes
1
Description
Total of first stage of delivery
Timepoint
Since intervention to full dilatation
Method of measurement
Timer
2
Description
Total of Second stage of delivery
Timepoint
Full Dilatation to delivery
Method of measurement
Timer
3
Description
Total of Third stage of delivery
Timepoint
From birth to Exit placenta
Method of measurement
Timer
Secondary outcomes
1
Description
Maternal outcomes (delivery type, frequency of use of oxytocin, the frequency of prolonged labor)
Timepoint
Start deliveries until the end of maternity
Method of measurement
check list
2
Description
Neonatal outcome (Apgar score)
Timepoint
Immediately after delivery
Method of measurement
check list
Intervention groups
1
Description
5% dextrose injection experimental group serum: serum administered dextrose 5% at a speed of 125 ml per hour in nulliparous women with vaginal delivery
Category
Treatment - Drugs
2
Description
The intervention group injected Ringer: Ringer prescribed speed of 125 ml per hour in nulliparous women with vaginal delivery
Category
Treatment - Drugs
3
Description
The control group received only oral liquid
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital in the city of Mahabad
Full name of responsible person
Fatemeh Ahadi yulgunlu
Street address
Imam Khomeini Hospital, Boulevard martyr Abdollahnejad, Western Azerbaijan
City
Mahabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
doc Mohammad Reza Rashidi
Street address
Center building of Tabriz Medical University, Golgasht Streat, Azadi Streat, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Farzane Shahmohammadi
Full name of responsible person
Fatemeh Ahadi Yulgunlu
Position
faculity of midwifery student
Other areas of specialty/work
Street address
Emam Streat - City chaharborg
City
chaharborg
Postal code
Phone
+98 44 4532 2868
Fax
Email
fatemehahadi8@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical and sciences of tabriz universcity
Full name of responsible person
Fahime Sehhatie Shaffaee
Position
Master degree
Other areas of specialty/work
Street address
blinding of Medical and Sciences University, Southern Shriati Streat, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 0648
Fax
Email
sehhatief@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical and Sciences of Tabriz
Full name of responsible person
Fahime Sehhatie Shafaee
Position
Master degree
Other areas of specialty/work
Street address
Bilding of Medical and Sciences University South Shariati, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3477 0648
Fax
Email
sehhatief@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)