This study compares oral misoprostol with vaginal misoprostol for induction of labor in post-term pregnancies. A total of 180 post-term pregnant women who admitted to the labor ward of Sanandaj Besat Hospital selected and randomly divided into three groups (each group consisting of 60 people). The induction was performed for the first group with 100 mcg misoprostol orally, for the second group with 50 mcg misoprostol orally and for the third group with 25 mcg misoprostol vaginally. Drugs were in three uniform boxes and after grouping the patients were given to them. The researcher was unaware of any grouping. After administration the desired group was recorded. Inclusion criteria included Gestational age (GA) greater or equal to 40 weeks and 6 days with cephalic presentation and Bishop score greater than 4 and height of 150 cm. Exclusion criteria included contraindications to receive misoprostol (allergies, asthma, Pelvic Inflammatory Disease, Acute Cerebrovascular Disease, Coronary Artery Disease, seizures) and also placenta previa , history of previous cesarean section or uterine surgery, Cephalopelvic Disproportion , Bishop score greater than 4, and abnormal vaginal bleeding. Data were analyzed by SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061412789N3
Registration date:2014-09-15, 1393/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-15, 1393/06/24
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of vaginal and oral dose of misoprostol for labor induction in post-term pregnancies
Public title
Effect of misoprostol in labor induction in post-term pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age (GA) greater or equal to 40 weeks and 6 days with cephalic presentation and Bishop score greater than 4 and a height of 150 cm. Exclusion criteria included contraindications to receive misoprostol (allergies, asthma, Pelvic Inflammatory Disease, Acute Cerebrovascular Disease, Coronary Artery Disease, seizures) and also placenta previa , history of previous cesarean section or uterine surgery, Cephalopelvic Disproportion , Bishop score greater than 4, and abnormal vaginal bleeding.
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:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects were selected and randomly divided into three groups through block randomization method. Drugs are placed in three same packages that labeled as (1, 2, and 3) and give to the nurse who is responsible for delivery. There is a questionnaire with each patient which determined patients grouping. Drugs would be administered to patients according to their grouping by nurse, and then the required information recorded. Researcher and monitoring committee are unaware of patients grouping.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Approval date
2013-09-18, 1392/06/27
Ethics committee reference number
14/21648
Health conditions studied
1
Description of health condition studied
Efficacy on induction of labor
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labour
Primary outcomes
1
Description
Interval from induction to delivery
Timepoint
From induction to delivery every 1 hour
Method of measurement
Vaginal exam for evaluation of dilatation and effacement
Secondary outcomes
1
Description
Fetal distress
Timepoint
At delivery time and 48 hours after that
Method of measurement
Based on the examination of the fetal heart rate and is determined by a specialist
Intervention groups
1
Description
Labor induction performs in group 3 by 25 micro grams misoprostol vaginally (posterior fornix). Based on conditions every 6 hours for 4 doses repeated. Before repeating each dose, vaginal examination to determine Bishop score will be done.
Category
Treatment - Drugs
2
Description
Labor induction performs in group 1 by 100 micro grams misoprostol orally. Based on conditions every 6 hours for 4 doses repeated. Before repeating each dose, vaginal examination to determine Bishop score will be done.
Category
Treatment - Drugs
3
Description
Labor induction performs in group 2 by 50 micro grams misoprostol orally. Based on conditions every 6 hours for 4 doses repeated. Before repeating each dose, vaginal examination to determine Bishop score will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Besat Hospital
Full name of responsible person
Soosan Mirza Mohammadi Sadegh
Street address
Keshavarz St., Besat Hospital
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Soosan Mirza Mohammadi Sadegh
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Keshavarz St., Besat Hospital
City
Sanandaj
Postal code
Phone
+98 87 1613 1336
Fax
Email
sumimo54@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Masomeh Rezaei
Position
Assistant professor
Other areas of specialty/work
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 1613 1281
Fax
Email
masomeh.rezaei@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Soosan Mirza Mohammadi Sadegh
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Keshavarz St., Besat Hospital
City
Sanandaj
Postal code
Phone
+98 87 1613 1336
Fax
Email
sumimo54@yahoo.com ,rasolabady@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)