This study was a double blind randomized clinical trial. The aim of this study was to evaluate the effect of Hyoscine-N-butylbromide on severity of pain during active phase of labor in primipara. 105 primigravid women with spontaneous labor were divided randomly in two groups of case and control. Either 40 mg of Hyoscine-N-butylbromide or placebo (2 ml normal saline) was injected intravenously at the beginning of active phase labor. Severity of pain was evaluated with VAS before injection and at times of 10, 20, 30, 60 and 120 minutes after injection. Duration of the first, second and third stages of labor, adverse maternal effect and APGAR score were secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080423444N1
Registration date:2015-08-11, 1394/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-11, 1394/05/20
Registrant information
Name
Zahra Pahlavani Sheikhi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 5542
Email address
z_pahlavani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous Hyoscine-N-butylbromide on active phase labor pain in primigravid women
Public title
The effect of intravenous Hyoscine-N-butylbromide on active phase labor pain in primigravid women
Purpose
Treatment
Inclusion/Exclusion criteria
Term pregnancy (37-42 weeks), pregnancy with a single live fetus, cephalic presentation, intact membrance, enter in the active phase of labor( cervical dilatation of 4 cm) with uterine contraction (at least 3 contraction lasting 40-60 seconds in 10 minutes), estimated fetal weight between 2500-4500 gr and absence of contraindication for vaginal delivery were the criteria for inclusion. The women with chronic induced illnesses, severe prepartum hemorrhage, preeclampsia, emergency cesarean section, prior uterine scar and the need to use other methods of analgesia (epidural analgesia or other opioids) were evicted from the study.
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:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Zahedan University of Medical Sciences
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
zahedan
Postal code
9816743463
Approval date
2013-02-28, 1391/12/10
Ethics committee reference number
91-1967
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
labor pain
Timepoint
before injection and at times of 10, 20, 30, 60 and 120 minutes after injection
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
lenght of active phase
Timepoint
durind of first stage of labor
Method of measurement
examination
2
Description
Duration of second stage of labor
Timepoint
During second stage of labor
Method of measurement
examination
3
Description
Duration of third stage of labor
Timepoint
During third stage of labor
Method of measurement
examination
4
Description
Apgar score
Timepoint
at 1st and 5th minutes
Method of measurement
examination
Intervention groups
1
Description
40 mg intravenous hyoscine single dose
Category
Treatment - Drugs
2
Description
2ml normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib hospital
Full name of responsible person
Zahra Pahlavani Sheikhi
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Taheri
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
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
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
Zahedan University of Medical Sciences
Full name of responsible person
Mahdiye Donyadari
Position
BSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
9819613396
Phone
+98 542438473
Fax
Email
m_20282000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Pahlavani Sheikhi
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
+98 54 3328 5542
Fax
Email
pahlavani_86@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Pahlavani Sheikhi
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
+98 54 3328 5542
Fax
Email
pahlavani_86@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)