Aim of research is effect of simultaneous intramuscular injection of Atropin and Hyoscine on labor progress in primigravid pregnant women. The method of research is randomized double blind placebo controlled clinical trial. Study population are primigravida pregnant who come to Arak Taleghani Hospital. Inclusion criteria: primigravida; cephalic presentation; age of pregnancy 37-42 weeks; dilatation of cervix 3-4 cm; membrane rupture and clear; no use cardiovascular drags; no use analgesic.
Exclusion criteria: meconium amniotic fluid; drug reaction or sensitivity; cephalopelvic disperoportion; macrosomia.
216 women randomly divided in 4 groups(intervention and control). One group(54 person) receive atropin 0/01mg/kg max(0/5 mg) single dose intramuscular. Second group (54 person) receive hyoscine 29 mg single dose intramuscular.Third group receive distilled water 1cc single dose intramuscular. Forth group receive atropin 0/01mg/kg max(0/5 mg) plus hyoscine 20 mg single dose intramuscular. Before intervention and one hour after intervention exam vaginally and measure progress of labor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304284686N6
Registration date:2013-05-07, 1392/02/17
Registration timing:na
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Not enough for processing
Funding source
Arak University of Medical Sciences ,vice president of education and research
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2013-11-29, 1392/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of simultanous intramuscular injection of Atropin and Hyoscine on labor progress in primigravid pregnant women
Public title
The effect of simultanous intramuscular injection of Atropin and Hyoscine on labor progress in primigravid pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primigravida; cephalic presentation; age of pregnancy 37-42 weeks; dilatation of cervix 3-4 cm; membrane rupture and clear; no use cardiovascular drags; no use analgesic.
Exclusion criteria: meconium amniotic fluid; drug reaction or sensitivity; cephalopelvic dicperoportion; macrosomiya.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
216
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
Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
91-135-5
Health conditions studied
1
Description of health condition studied
labor progressr
ICD-10 code
O80.0
ICD-10 code description
cases with minimal or no assistance, with or without episiotomy delivery in a completely normal case
Primary outcomes
1
Description
labor progress
Timepoint
before intervation and one hour after intervation
Method of measurement
vajinal exam
Secondary outcomes
1
Description
drug side effects
Timepoint
before intervention and one hour ater intervention
Method of measurement
vajnal exam
Intervention groups
1
Description
First group(54 person) receive atropin 0/01mg/kg max(0/5mg) single dose intramascular
Category
Treatment - Drugs
2
Description
Second group (54 person) receive hyoscine 20mg single dose intramascular
Category
Treatment - Drugs
3
Description
Third group (54 person) receive distilled water 20mg single dose intramascular
Category
Treatment - Drugs
4
Description
Forth group(54 person) receive atropin 0/01mg/kg max0/5mg plus hyoscine 20mg single dose intramascular
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medival Sciences
Full name of responsible person
Dr. Ashtiyani
Street address
Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medival 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
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology, Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1278 0660
Fax
Email
mjamilian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology, Assistant professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Boadr of Obstetric
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arark
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)