To find out the effect of Hyoscine - N - Butyl Bromide suppository on labor pain and process this study was down on 130 nulliparous term pregnant women who came to Ahwaz Sina hospital due to the beginning of spontaneous labor pain in 2009. The samples were divided randomly into groups of case (n=65) and control (n=65). A Hyoscine suppository (20 mg) was given to case group and a placebo suppository was given to control group in the beginning of active phase of labor rectally. Then the labor pain, cervical dilatation and effacement progress and active phase and second stage duration and delivery type were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804282204N1
Registration date:2010-02-10, 1388/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-10, 1388/11/21
Registrant information
Name
Somayeh Makvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 604 2247
Email address
s-makvandi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapur University of Medical Sciences
Expected recruitment start date
2009-07-03, 1388/04/12
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hyoscine - N - Butyl Bromide suppository on labor pain and process in nuliparous women
Public title
The effect of Hyoscine -suppository on labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.age 18-35 2. gestational age: 37-42 by LMP or under 26 weeks by sonography 3.single fetus 4. cephalic presentation 5.cervical dilatation= 3-4 cm 6. Cervical effacement = 30-60% 7.bishop score>7 8.spontaneous uterine contractions in the form of 3 contractions with 40 minutes duration per 10 min 9.minimum education= grade 5 at primary school. Exclusion criteria : 1.vaginal bleeding 2.abnormal fetal heart rate 3.neonatal body weight<2500 or >4000 gr 4.fetal abnormality or death 5.high risk pregnancy 6.history of uterine surgery 7.mother's tachycardia 8.history of medical disorder in mother 9.oxytocin infusion in labor stages 10.use of Narcotic or anodyne drug or other pain reliever methods 11.delivery in 2 hours from onset of study 12.Athletic mothers 13.addict mothers 14.Corporation in pre-labor education classes
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Ahwaz Jondishapur University of Medical Sciences
Street address
Golestan
City
Ahwaz
Postal code
Approval date
1388-03-12, 769/01/-737
Ethics committee reference number
U-88242
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O80.0
ICD-10 code description
spontaneus vertex delivery
2
Description of health condition studied
Labor process
ICD-10 code
O80.0
ICD-10 code description
spontaneus vertex delivery
Primary outcomes
1
Description
labor pain
Timepoint
each 0.5 h
Method of measurement
visual analog scale
2
Description
cervical dilatation
Timepoint
each 1 h
Method of measurement
examination
3
Description
cervical effacement
Timepoint
each 1 h
Method of measurement
examination
4
Description
labor active phase duration
Timepoint
at the end
Method of measurement
observation
5
Description
labor second stage duration
Timepoint
at the end
Method of measurement
observation
6
Description
delivery type
Timepoint
at the end
Method of measurement
observation
Secondary outcomes
1
Description
neonatal Apgar score
Timepoint
at 1st and 5th minutes
Method of measurement
Examination & Ovservation
2
Description
maternal blood pressure
Timepoint
each 0.5 h
Method of measurement
examination
3
Description
fetal heart rate
Timepoint
each 0.5 h
Method of measurement
examination
4
Description
maternal pulse rate
Timepoint
each 0.5 h
Method of measurement
examination
Intervention groups
1
Description
hyoscine suppositiry 20 mg single dose
Category
empty
2
Description
placebo suppository
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor of Ahwaz jondishapour university of medical sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Golestan
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Ahwaz jondishapour university of medical sciences