82 patients were randomly selected. Subjects were randomly divided into two groups. In one group (41 persons) Oxytocin was given and in the other group (41 patients) 50 mg sublingual Misoprostol was administered. In the first group, in the case of inappropriate contractions, the starting dose of 1 mµ / min dose of Oxytocin was given every 15 min, until appropriate contractions started. In the second group 50 mg of sublingual Misoprostol was given .the patients did not received any other medicine, in first 6 hours after taking Oxytocin. Contractions of the patients were noted for their intensity and frequency, for 6 hours. If inappropriate contractions were observed after 6 hours, a starting dose of 1 mµ / min of Oxytocin was given every 15 min until appropriate contractions started. Finally ̨ delivery improvement Bishop score of 8 and more ̨ Apgar score, Meconium ̨ delivery method, uterine activity and fetal distresses were recorded.
Finally, all information obtained in each study group was evaluated and the data from the two groups were compared statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013032512856N1
Registration date:2014-08-21, 1393/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-21, 1393/05/30
Registrant information
Name
Parisa Karimkhani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
p.karimkhani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2013-08-24, 1392/06/02
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of sublingual Misoprostol and Oxytocyn in labor duration
Public title
Comparison of the effects of sublingual Misoprostol and Oxytocyn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy; first or second alive delivery; Bishop Score of 4 or more, no history of any internal disorders, age between 18 to 35 years old.
Exclusion criteria: twin pregnancy and contraindications of induction.
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:
82
Randomization (investigator's opinion)
Randomized
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
16/35/9/1279/پ/د
Health conditions studied
1
Description of health condition studied
Labor
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Labor time
Timepoint
Before and after intervention
Method of measurement
Hour
Secondary outcomes
1
Description
Time to Bishop 8 and kind of delivery
Timepoint
After intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
In intervention group, in the case of inappropriate contractions, the starting dose of 1 mµ / min dose of Oxytocin was given every 15 min, until appropriate contractions started.
Category
Treatment - Drugs
2
Description
In the control group 50 mg of sublingual Misoprostol was given. The patients did not received any other medicine, in first 6 hours after taking Oxytocin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital of Hamedan
Full name of responsible person
Soghra Rabiee
Street address
Fatemieh hospital of Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences, research department
Full name of responsible person
Saeed Bashirian
Street address
Fatemieh hospital of Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences, research department
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
Hamedan University of Medical Sciences
Full name of responsible person
Soghra Rabiee
Position
Specialist/ professor
Other areas of specialty/work
Street address
Fatemieh hospital- Pasdaran Ave.- Hamedan
City
Hamedan
Postal code
Phone
+98 81 1827 7082
Fax
+98 81 1827 7082
Email
rabieesogol@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Soghra Rabiee
Position
Specialist/ professor
Other areas of specialty/work
Street address
Fatemieh hospital -Pasdaran Ave.- Hamedan
City
Hamedan
Postal code
Phone
+98 81 1827 7082
Fax
+98 81 1827 7082
Email
rabieesogol@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Soghra Rabiee
Position
Specialist/ professor
Other areas of specialty/work
Street address
Fatemieh hospital- Pasdaran Ave.-Hamedan
City
Hamedan
Postal code
Phone
+98 81 1827 7082
Fax
+98 81 1827 7082
Email
rabieesogol@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)