The aim of the study was to compare the effect of Nitric Oxide (Isosorbide Mononitrate) versus Misoprostol in cervix ripening and labor progression. This study is a randomized clinical . Women with term pregnancies will refer for induction of labor with bishop score of 6 or less are randomly allocated to receive either 40 – mg isosorbide mononitrate (IMN) tablet vaginalley or 25– microgram misoprostol vaginally every 6 hours for maximum of three doses. The Inclusion criteria is contain term pregnancy having indication for termination; Bishop score less than 6; not using another method for cervical ripening.
Exclusion criteria: preterm pregnancies; Bishop-score of 6; coagulation disorder; Cesarean section; severe preeclampsia; primary hypo tension; any type of heart disease; using any medication for heart disease, anticoagulants, contortionists and history for adrenal disease.
Variables including: 1. Bishop score 2. Age 3. parity 4. Type drug 5. Need to augment 6. the time of effect 7. contractions hypertension 8. Apgar.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031233025N1
Registration date:2017-04-12, 1396/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Marzieh Lotfalizade
Name of organization / entity
Mashhad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
lotfalizadem@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of isosorbide mono nitrate and misoprostol for cervical ripening for labor in term pregnancy
Public title
Compare the effects of isosorbide mono nitrate and misoprostol for cervical ripening for labor in term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy having indication for termination; Bishop score less than 6; not using another method for cervical ripening.
Exclusion criteria: preterm pregnancies; Bishop-score of 6; coagulation disorder; Cesarean section; severe preeclampsia; primary hypo tension; any type of heart disease; using any medication for heart disease, anticoagulants, contortionists and history for adrenal disease.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2010-10-28, 1389/08/06
Ethics committee reference number
89886
Health conditions studied
1
Description of health condition studied
Term pergnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Apgar score
Timepoint
after intervention
Method of measurement
According to expert examination
Secondary outcomes
1
Description
Bishop Scale
Timepoint
After intervention
Method of measurement
According to expert examination
2
Description
Effective time
Timepoint
After intervention
Method of measurement
Hours
3
Description
Hypertension et contractions
Timepoint
After intervention
Method of measurement
According to expert examination
Intervention groups
1
Description
40 mg Isosorbide Mononitrate will be given ever 6 hours in 3 dose At intervals of 0, 6 and 12 hours.
Category
Treatment - Drugs
2
Description
25 µg misoprostol will be given ever 6 hours in 3 dose At intervals of 0, 6 and 12 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Obstetrics department , Imam Reza Hospital
Full name of responsible person
Secretary
Street address
Imam Reza Hospital, Taghi Abad Square, Mashhad,Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Mashhad University of Medical Sciences, Daneshgah Street.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Lotfalizade
Position
Faculty member
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3802 2608
Fax
Email
lotfalizadem@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Marzieh Lotfalizade
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3802 2608
Fax
Email
lotfalizadem@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
MSc
Other areas of specialty/work
Street address
Woman Health Resaerch Center, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Postal code
00989137913316
Phone
+98 51 3802 2631
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)