When labor induction is indicated for women with unripe cervix and oxytocin induction alone will not be answered, there is severel choices for ripening of cervix with low bishop score. Transcervical catheter and misoprostol are kinds of them.This research will compare benefits and disadvantages of this two procedures.Term pregnant women with indication of delivery and low bishop score of cervix divide to same 60 groups of getting misoprostol or transcervical catheter and then evaluate time of ripening of cervix,c/s rate,and other disadvantages such as meconium in amnionic fluid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012225448N1
Registration date:2011-05-04, 1390/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-04, 1390/02/14
Registrant information
Name
Fateme Mallah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133336360
Email address
mallahf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences, Research Chancellory
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and side effects of transcervical catheter and vaginal Misoprostol on cervical ripening
Public title
The comparison of drug and mechanical methods for cervical ripening before delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:gestatinal age over 37 weeks, singleton gestation,cephalic presentation, intact amnion sac,not contraindication of misoprostol use,first gravity ,3 to 4 bishop score
Exclusion criteria:allergy to misoptostol,elective cesarean section,urgent delivery by c/s,IUGR,placenta previa,fetal bradycardia, placenta abruption,massive bleeding ,placenta previa and previous cesarean section.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences,Vice chancellor for Research
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2010-10-09, 1389/07/17
Ethics committee reference number
5/4/6866
Health conditions studied
1
Description of health condition studied
Ripening Of Cervix
ICD-10 code
O60-O75
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
Ripening of cervix
Timepoint
in the time of intervention
Method of measurement
bishop score
Secondary outcomes
1
Description
Meconium In Amnionic Fluid
Timepoint
at time of intervention
Method of measurement
Clinical
2
Description
Uterine Hyperstimulation
Timepoint
at time of intervention
Method of measurement
clinical
3
Description
Rupture of uterin
Timepoint
at time of intervention
Method of measurement
clinical
4
Description
Result in c/s
Timepoint
at time of intervention
Method of measurement
Clinical
5
Description
Fetal Bradycardia
Timepoint
In the time of intervention
Method of measurement
Clinical
Intervention groups
1
Description
Misoprostol 25 microgram per 8 hour until 3 doses will be used in 60 patients with the cervix bishop score 3 or 4. Then duration time to reach 8 bishop score will be measured.
Category
Treatment - Other
2
Description
On the other 60 ones with cervix bishop score of 3or4, transcervical catheter will be used. time of receiving to cervix bishop score of 8 will be evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital-Tabriz and Alzahra Hospital Tabriz
Full name of responsible person
Dr.Fatemeh Mallah
Street address
Taleghani Hospital, Rah Ahan Square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciencesو Vice chancellor for Research
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Sciencesو 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
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Fatemeh Mallah
Position
Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Rah Ahan Sq
City
Tabriz
Postal code
00984113344280
Phone
+98 41 1442 4423
Fax
+98 41 1556 6449
Email
mallahf@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir/research
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Fatemeh Mallah
Position
Assistent professor
Other areas of specialty/work
Street address
Taleghani Hospital Rah Ahan Sq
City
Tabriz
Postal code
5138665793
Phone
+98 41 1442 4423
Fax
+98 41 1556 6449
Email
mallahf@tbzmed.ac.ir
Web page address
www.tbzmed.ac .ir/research
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Sanaz Alinejati
Position
Assistant Professor of Gynecology And Obstetrician
Other areas of specialty/work
Street address
Taleghani Hospital, Rah Ahan Sq
City
Tabriz
Postal code
5138665793
Phone
+98 41 1442 4423
Fax
+98 41 1556 6449
Email
sanaz.alinejati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)