Determining the effect of saline dextrose solution compared with normal saline on the duration of the active delivery phase in Noli Par women
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 0 on 60 patients. The table of random numbers was used for randomization.
Settings and conduct
This clinical trial study will be performed on Noli Par women visiting Imam Reza, Ghaem and Umm Al-Banin hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Noli Par women, age between 18 to 40 years old
Exclusion criteria: Dissatisfaction with participation in the study, having underlying disease
Intervention groups
In the intervention group, saline dextrose solution (5% dextrose and 0.9% sodium chloride) is infused by pump to the mother. (150 cc per hour)
Main outcome variables
71/5000
The duration of the active phase of labor (from 5 cm dilatation to complete dilatation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047838N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Seyedeh Sepideh Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
sepidehh787@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of dextrose saline compared to normal saline on the duration of active phase of labor in nulliparous women
Public title
Evaluation the effects of dextrose saline compared to normal saline on the duration of active phase of labor in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy age between 37 and 40 weeks
Single pregnancy
Ceramic perforation
Cervical dilatation 5 cm
Exclusion criteria:
pregnant who fetuses have intrauterine growth restriction
BMI is more than 40
Poly hydramnios
People with diabetes and preeclampsia
Kidney patients
existence of active infection in the mother
Maternal heart disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with a table of random numbers. In this way, the computer generates random numbers between 0 and 1. If the random number is less than 0.500, the person will enter the intervention group. If the random number is greater than 0.500, the person enters the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participations and ِِِِِِِِِِِِِِِِِِِِِcareprovuder do not know who is in which group. Individuals were identified as groups A and B so that the statistician was unaware of the type of drug and the patients themselves were unaware of the drug being injected.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.061
Health conditions studied
1
Description of health condition studied
Long labour
ICD-10 code
O63
ICD-10 code description
Long labor
Primary outcomes
1
Description
The duration of the active phase of labor (from 5 cm dilatation to complete dilatation)
Timepoint
after intervention
Method of measurement
5 cm dilatation to complete dilatation
Secondary outcomes
1
Description
The length of the second stage of labor (from complete dilatation to the birth of the baby)
Timepoint
after intervantion
Method of measurement
complete dilatation to the birth of the baby
Intervention groups
1
Description
Intervention group: In the intervention group, dextrose saline solution solution (5% dextrose and 0.9% sodium chloride) is infused by pump to the mother. (150 cc per hour)
Category
Other
2
Description
Control group: In the control group, normal saline solution with pump device to regulate the drops, noli Par women in the active phase of childbirth are prescribed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Sepideh Hoseini
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2632
Email
Dr.Sepideh.hosseini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
International Offic Administration Center(Qoreishi Building) ; Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Sepideh Hosseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2632
Email
Dr.Sepideh.hosseini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Sepideh Hosseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2632
Email
Dr.Sepideh.hosseini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Sepideh Hosseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١
Phone
+98 51 3802 2632
Email
Dr.Sepideh.hosseini@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data as SPSS file
When the data will become available and for how long
After publishing of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is permissible to compare our data by studying others by citing the source on the delivered data
From where data/document is obtainable
Send an email to Dr.Sepideh.hosseini@gmail.com
What processes are involved for a request to access data/document
After sending an email and justifying the author about not using the data, the data is sent to the researcher.