The aim of this study is to determine that outpatient pre induction cervical ripening with Isosurbidemononitrate improves the process of induction of labor. Economic evaluation conducted a randomized placebo controlled trial. In zero phase , women who required labor induction for unfavorable cervices ( bishop score less than 6 ) each has singleton pregnancy with a Live fetus at least 37 weeks of gestation . In first phase, after examination, give their randomized study medication (either 2 Isosurbidemononitrate tablet or 2 placebo), to self –administers the tablet vaginally starting 24, 48 h before scheduled admission for induction of labor. In the second phase, women admit after trial medication, cervical status (Bishop Score) assess and labor induce with oxytocin protocol as pes ACOG guidelines. We will analyze outcomes of elapsed time from hospital admission to vaginal delivery.
General information
Acronym
IMN
IRCT registration information
IRCT registration number:IRCT201301134850N2
Registration date:2013-04-16, 1392/01/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-16, 1392/01/27
Registrant information
Name
Shokoh Alsadat Haji Seyed Abotorabi
Name of organization / entity
Qazvin,University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1369 0035
Email address
shabotorabi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice -chancellor for research, Qazvin university of medical sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The safety and cost-effective of Isosurbidemononitrate prior to induction of labor
Public title
The safety and cost-effective of Isosurbidemononitrate prior to induction of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women have a singleton term pregnancy with a Live fetus; absence of uterine contractions and intact membranes.
Exclusion criteria: fetal mal presentations; placenta previa; previous uterine incision or any contraindication of labor induction in ACOG
Age
To 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Science and health services
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
28/20/6765
Health conditions studied
1
Description of health condition studied
termination of term pregnancy
ICD-10 code
O48
ICD-10 code description
Prolonged pregnancy
Primary outcomes
1
Description
Elapsed time induction of labor
Timepoint
Duration based on birth curves records
Method of measurement
Questionnaire
2
Description
Elpsed time interval from hospital admission to vaginal delivery
Timepoint
Based on the information entered in the records
Method of measurement
Questionnaire
Secondary outcomes
1
Description
parity
Timepoint
Age at admission
Method of measurement
Questionnaire
2
Description
age
Timepoint
Age at admission
Method of measurement
Questionnaire
Intervention groups
1
Description
self adminstration of Isosurbidemononitrate tablet vaginally starting 24,48 h before schedule admission .
Category
Treatment - Drugs
2
Description
self adminstration of placebo tablet vaginally starting 24,48 h before schedule admission .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Dr Shokoh Sadat Haji Seyed Abotorabi , Obstetrics & gynecologist
Street address
khameneie Blvd
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Qazvin University of Medical Science
Full name of responsible person
Dr Sayed Assefzadeh
Street address
Post code431102589, Plate 3, Shahid Bahonar Blvd, Qazvin City
City
Qazvin
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 of Qazvin University of Medical Science
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
Qazvin University Of Medical Sciences & Health Services
Full name of responsible person
Dr Shokoh sadat Haji Seyed Abotorabi
Position
Obstetrics & gynecologist
Other areas of specialty/work
Street address
Kosar Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
shabotorabi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences & Health Services
Full name of responsible person
Dr Shokoh sadat Haji Seyed Abotorabi
Position
Obstetrics & gynecologist
Other areas of specialty/work
Street address
Kosar Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
shabotorabi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University Of Medical Sciences & Health Services
Full name of responsible person
Dr Shokoh sadat Haji Seyed Abotorabi
Position
Obstetrics & gynecologist
Other areas of specialty/work
Street address
Kosar Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
shabotorabi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)