The purpose of this study was to compare labor induction with oral misoprostol and labor induction with oxcytocin. A total of 65 women with an induction were randomized into 2 groups. Inclusion criteria were: Gestational age 39 to 42 weeks; weighing an estimated birth to 4000 g; the heartbeat of the fetus; Cephalic presentation. The misoprostol group received 25 mcg every two hours for up to 24 hours for induction. The oxytocin group received an infusion of 10 IU. The time from induction to delivery and induction to the beginning of the active phase and successful inductions within 12, 18, and 24 hours were recorded in addition to caesarean sections and reasons.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080610511N1
Registration date:2012-09-13, 1391/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-13, 1391/06/23
Registrant information
Name
Maryam Karamali
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
dr.karamali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of characteristics of women undergoing labor induction with oxytocin and oral misoprostol
Public title
Comparison of characteristics of women undergoing labor induction with oxytocin and oral misoprostol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 39 to 42 weeks of gestational age; Estimated fetal weight 4000 g; Normal fetal heart rate; cephalic presentation; Absence of uterine contractions; Singleton pregnancy; Bishop score of 7 or less. Exclusion criteria: Previous uterine surgery including caesarean section; Intrauterine fetal death IUGR; Oligohidroamnius; Placenta previa; Umbilical cord Prolapse; Corioamnionitis symptoms; Symptoms of active herpes; kidney or liver disease; NST Non-Stress Test reactive bread; Contraindication for Administration of prostaglandin. Contraindication for induction of labor; Vaginal bleeding of unknown cause.
Age
From 17 years old to 36 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
65
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
Shahid Beheshti University Of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid chamran Highway
City
Tehran
Postal code
1985717443
Approval date
2010-02-17, 1388/11/28
Ethics committee reference number
111
Health conditions studied
1
Description of health condition studied
Induction of Labor
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labour
Primary outcomes
1
Description
Time of induction to active phase
Timepoint
During 12, 18, 24 hours
Method of measurement
clock
2
Description
Start time of induction to delivery
Timepoint
During 12, 18, 24 hours
Method of measurement
clock
Secondary outcomes
empty
Intervention groups
1
Description
First group received oral misoprostol, 25 mcg every 2 hours for up to 24 hours
Category
Treatment - Drugs
2
Description
The oxytocin group recevied an infusion of 10 IU. Starting with four drops per minute, which was doubled each quarter hour up to 64 drops.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadae Tajrish Hospital
Full name of responsible person
Dr Maryam Karamali
Street address
Hospital Shohada, Tajrish St. District 01
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Rahmati Roodsari
Street address
Shahid Beheshti University of Medical Sciences،Velenjak Street, Shahid Chamran High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of medical sceinces
Full name of responsible person
Dr Maryam Karamali
Position
Specialist in Obestetrics & Gynocology
Other areas of specialty/work
Street address
Shohadaetajrish Hospital
City
Tehran
Postal code
1985717443
Phone
+98 21 2271 9013
Fax
Email
dr.karamali@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of medical sciences
Full name of responsible person
Dr Maryam Karamali
Position
Spesialist in Obestetrics & Gynocology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences،Velenjak street, Shahid Chamran High way
City
Tehran
Postal code
1985717443
Phone
00892122719013
Fax
+98 21 2271 1200
Email
Dr.karamali@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of medical sciences
Full name of responsible person
Dr Maryam Karamali
Position
Specialist in Obestetrics & Gynocology
Other areas of specialty/work
Street address
Shahid Beheshti University of medical sciences, Velenjak, Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 2271 9013
Fax
+98 21 2271 1200
Email
dr.karamali@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)