Evaluation of Hyoscine butylbromide effects on pain severity of first stage of labor and fetal heart rate in multiparous women
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 100 women during the labor
Settings and conduct
This study will be conducted with the aim of evaluation of Hyoscine butylbromide effects on pain severity of first stage of labor and fetal heart rate in 100 multiparous women. After inclusion in the study, using block randomization method with blocks of ten, the patients will be assigned into two groups; intervention group receiving 20 mg Hyoscine (1 ml) intravenously and control group receiving 1 ml normal saline. The injections in both groups will be intravenously and during the active phase of labor. Pain severity will be measured by Visual Analog Scale (VAS) and Fetal Heart Rate will be measured by using a specific device and will be compared together.
Participants/Inclusion and exclusion criteria
Age of 18-35; Singleton pregnancy; Not having pregnancy complications such as gestational diabetes; Gestational age of 37-42 weeks
Intervention groups
Intervention group: Receiving 20 mg hyocine (1 ml) intravenously during the active phase of labor
Control group: Receiving 1 ml normal saline intravenously during the active phase of labor
Main outcome variables
Pain severity of first stage of labor; Fetal Heart Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180424039407N1
Registration date:2018-07-04, 1397/04/13
Registration timing:retrospective
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Afra Pazhouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
a.pazhouhi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Hyoscine butylbromide effects on pain severity of first stage of labor and fetal heart rate in multiparous women
Public title
Evaluation of Hyoscine butylbromide effects on pain severity of first stage of labor and fetal heart rate in multiparous women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-35
Singleton pregnancy
Not having pregnancy complications such as gestational diabetes
Gestational age of 37-42 weeks
Exclusion criteria:
Cardiovascular disease
Hypo- or hyperthyroidism
Preeclampsia
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with blocks of ten
Considering the sample size of 100, 10 blocks with 10 cards (5 cards for each group) will be selected; by selecting each block, 5 patients will be assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo will be coded as A and B and will be similar in shape so the patient and the caregiver (patient's physician) will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.ZAUMS.REC.1396.213
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery
Primary outcomes
1
Description
Pain severity of first stage of labor
Timepoint
During the first stage of labor
Method of measurement
By using Visual Analog Scale (VAS)
2
Description
Fetal Heart Rate
Timepoint
During the full labor time
Method of measurement
By using a sonicaid device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 20 mg Hyoscine (1 ml) intravenously during the active phase of labor
Category
Treatment - Other
2
Description
Control group: Receiving 1 ml normal saline intravenously during the active phase of labor
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Afra Pazhouhi
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Afrapazhouhi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Afra Pazhouhi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Afrapazhouhi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Afra Pazhouhi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Afrapazhouhi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Afra Pazhouhi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Afrapazhouhi@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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