Goal of the study is to compae the efficacy and complications of sublingual versus vaginal misoprostol for induction of labor by a triple- blind study for women in term pregnancy.Goal of the study: Comparison of the efficacy and complications of sublingual versus vaginal misoprostol for induction of labor by a triple- blind study for women in term pregnancy. 200 pregnent women with the inclusion criteria will enter the study. Sublingual and vaginal tablets containing 25 µg misoprostol and placebo will be prepared for the study by pharmaceutics division of Shiraz University of Medical Sciences. Medication-packages will be prepared and coded. All of the packages will contain two plastic bags, one of them sublingual tablets and the other bag vaginal suppositories. In each package only one of the plastic bags will contain misoprostol and the other one is placebo. Both types of preparations will be used for every woman who enters the study. Only the pharmaceutics will know that which bag contained the active form of medication.َ Medications will be repeated every 4 hours until cervical Bishop Score advances to more than 8. Close observation of the mother and continuous fetal heart monitoring will be performed for all of these patients. After the final analysis the code will be broken.
General information
Acronym
Misoprostol
IRCT registration information
IRCT registration number:IRCT201402096541N3
Registration date:2014-02-17, 1392/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-17, 1392/11/28
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences- Vice Chancellor for research
Expected recruitment start date
2009-02-01, 1387/11/13
Expected recruitment end date
2013-02-28, 1391/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and complications of sublingual versus vaginal misoprostol for induction of laborfor women in term pregnancy
Public title
Comparison of the efficacy and complications of sublingual versus vaginal misoprostol for induction of laborfor women in term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:first singleton alive pregnancy; gestational age of ≥37 weeks: cephalic presentation: estimated fetal weight of less than 4000 grams; Bishop Score <7.
Exclusion criteria: : hypersensitivity to prostaglandins; previous uterine scar; fetal congenital malformations; intrauterine growth restriction; non-reassuring fetal heart; gestational age <37 weeks; oligohydramnious.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Review Board, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz.
City
Shiraz
Postal code
Approval date
2011-06-02, 1390/03/12
Ethics committee reference number
CT-90-5589
Health conditions studied
1
Description of health condition studied
Pregnancy , childbirth and the puerperium (O00-O99)
ICD-10 code
O61
ICD-10 code description
failed induction of labour
Primary outcomes
1
Description
the time needed for delivery
Timepoint
Medication starting time to delivery
Method of measurement
Measurement of the time needed after aplication of medication to delivery
2
Description
Fetal safety
Timepoint
at delivery
Method of measurement
By evaluation of neonata blood gas at birth
Secondary outcomes
1
Description
the effect of drugs on the fetal safety
Timepoint
After birth
Method of measurement
Apgar scors and NICU admissions
2
Description
Fetal safety
Timepoint
during labor
Method of measurement
meconium passage
Intervention groups
1
Description
The control group: will recieve vaginal supositories containing 25 microgram misoprostol and sublingual tablets of placebo.
Category
Treatment - Drugs
2
Description
The intervention group: will recieve 25 microgram tablets of misoprostol and vaginal supositories containing placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital and Hazrate Zeinab Hospitals
Full name of responsible person
Bahia namavar Jahromi
Street address
dep. of OB-GYN, Shahid Faghihi Hospital, Shiraz, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences- Vice Chancellor for Research
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shahid Faghihi Hospital, Shiraz , Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences- Vice Chancellor for Research
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
School of Medicine, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
Professor in the department of OB-GYN
Other areas of specialty/work
Street address
Department of OB-GYN, Shahid Faghihi Hospital, Shiraz , Iran
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
namavarb@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences- Vice Chancellor for research
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
professor
Other areas of specialty/work
Street address
Department of OB-GYN, Shahid Faghihi Hospital, Shiraz , Iran
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
namavarb@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
Professor
Other areas of specialty/work
Street address
Department of OB-GYN, Shahid Faghihi Hospital, Shiraz , Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
namavarb@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)