Comparative study of bicarbonate oral intake and infusion of oxytocin versus infusion of oxytocin alone on resolving the labor active phase dystocia in primiparous women
Comparison of bicarbonate oral intake and infusion of oxytocin versus infusion of oxytocin alone on resolving the labor active phase dystocia in primiparous women
Design
clinical trial
Settings and conduct
The targer population included all nulliiparous women admitted to maternity wards of the Jiroft University of Medical Sciences for delivery and they have the entry criteria of the study.
Intervention group will use oral bicarbonate as 4.26 g of sodium bicarbonate. Each pack of oral bicarbonate is taken in a glass containing 200 cc of water . In the control group, without Prescribing of bicarbonate induction continues and The Pareto graph form is completed by the midwife until the end of the third stage of labor.
Participants/Inclusion and exclusion criteria
inclusion criteria: nulliparity, gestational age of 42-37 weeks, entry into active phase of labor, absence of known fetal complications, fetal macrosomia and severe pre-eclampsia in the mother, A cephalic presentation and labor is stopped according to the partogram pattern (stopping dilatation for one hour) In women who are being induced. Exclusion criteria: the mother's regret to cooperate at each stage of the study
Intervention groups
Primiparous women with the labor active phase dystocia for one hour or more
Main outcome variables
Duration of the first and second stages of labor, type of delivery, Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042051N2
Registration date:2019-05-16, 1398/02/26
Registration timing:registered_while_recruiting
Last update:2019-05-16, 1398/02/26
Update count:0
Registration date
2019-05-16, 1398/02/26
Registrant information
Name
Zohreh Ghorashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
zghorashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-06-04, 1398/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of bicarbonate oral intake and infusion of oxytocin versus infusion of oxytocin alone on resolving the labor active phase dystocia in primiparous women
Public title
The effect of bicarbonate oral intake and infusion of oxytocin on resolving the labor active phase dystocia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravidity, gestational age of 37-42 weeks, entry into active phase, absence of known fetal complications and macrosomia, abscence of severe pre-eclampsia in the mother,Cephalic presentation with a single pregnancy and labor is stopped according to the partogram pattern (stopping dilatation for one hour).
gestational age of 37-42 weeks
entry into active phase
absence of known fetal complications
absence of macrosomia
abscence of severe pre-eclampsia
Cephalic presentation
single pregnancy
labor is stopped according to the partogram pattern (stopping dilatation for at least one hour) In women who are being induced
Exclusion criteria:
Exclusion criteria:The mother's regret to cooperate at each stage of the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
142
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Parastar Street, School of nursing midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2019-01-11, 1397/10/21
Ethics committee reference number
IR.RUMS.REC.1397.182
Health conditions studied
1
Description of health condition studied
The labor active phase dystocia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dilatation progress
Timepoint
Every hour in active phase
Method of measurement
Vaginal examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Drinking oral bicarbonate solution and oxytocin infusion after disticia. Each pack of bicarbonate contains 4.26g of sodium bicarbonate that mixed in 200 cc water in a glass and it will be drank by eligible women within a few minutes . Sodium bicarbonate with NaHCO3 formula has been purchased from the German company (Merck).
Category
Treatment - Other
2
Description
Control group: without Prescribing of bicarbonate, induction continues and The Pareto graph form is completed by the midwife until the end of the third stage of labor.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Maternity Wards covered by Jiroft University of Medical Sciences
Full name of responsible person
Mitra Seyedinejad
Street address
Modares
City
Jiroft
Province
Kerman
Postal code
7861735133
Phone
+98 34 4321 0264
Email
mitraseyedi42@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Street address
School of nursing midwifery, Parastar Street, Rafasanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
zghorashi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
zohreh ghorashi
Position
Assistant proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kargar Street
City
Rafsanjan
Province
Kerman
Postal code
7716614867
Phone
+98 34 3428 9264
Fax
+98 34 3425 8497
Email
zghorashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
zohreh ghorashi
Position
Assistant proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing midwifery, Parastar Street, Rafsaanjn, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
zghorashi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
zohreh ghorashi
Position
Assistant proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Parastar Street, School of nursing midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 9264
Email
zghorashi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available