Comparison the effects of the isosorbide mononitrate with misoprostol and misoprostol with placebo for cervical ripening in induction of labour in 41 week pregnancies.
In this study, we will compare the threptic effect and complications of isosorbide mononitrate. First pregnancies aged more than 41 weeks will enrolled the study based on the first trimester sonography (before 20 weeks of gestation) or last menstrual period (LMP). Patients will be divided into two groups regard to random block method. And patients and physician will not be aware of administered package. Firstly, 25 mg vaginal misoprostol will be administered and will be followed by 40 mg vaginal isosorbide mononitrate or placebo. Fetal heart rate and uterine contractions will be monitored permanently. Maternal heart rate and blood pressure will be also measured each 30 minutes. Patients will be reevaluated every 6 hours for other misoprostol administration, and this will be continued for at least 6 dose or until more than 3 uterine contraction longer than 40 seconds each 10 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022426745N1
Registration date:2017-05-16, 1396/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Maryam Ghaffarian Omid
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3223 1444
Email address
ghaffarianm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad university of medical sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-04-27, 1396/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of the isosorbide mononitrate with misoprostol and misoprostol with placebo for cervical ripening in induction of labour in 41 week pregnancies.
Public title
Comparison the effects of the isosorbide mononitrate with misoprostol and misoprostol with placebo for cervical ripening in induction of labour in 41 week pregnancies.
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are first pregnancies aged more than 41 weeks based on the sonography; with single; normal fetus; and cephalic presentation with no complication and before induction bishop score less than 6.
Exclusion criteria include known allergy for prostaglandins or mifepristone; any contraindication for induction (such as uterine scar); contraindications for mifepristone administration (like adrenal, renal or liver disease); major cephalopelvic disproportion; abnormal stress test; vaginal bleeding and sever oligohydramnios.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
186
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
Mashhad University of Medical Sciences, Mashhad, Iran
Street address
Iran, Mashhad, Daneshgah St,Qoreishi Building
City
Mashhad
Postal code
1234567
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
IR.MUMS.fm.REC.1394.359
Health conditions studied
1
Description of health condition studied
prolonged pregnancy
ICD-10 code
O48
ICD-10 code description
Prolonged pregnancy
Primary outcomes
1
Description
fetal heart rate
Timepoint
each 30 minutes
Method of measurement
quantitative with sonography
Secondary outcomes
1
Description
maternal blood pressure
Timepoint
each 30 minutes
Method of measurement
quantitative with pressure indicator
Intervention groups
1
Description
25 mg vaginal misoprostol will be administered and will be followed by 40 mg vaginal isosorbide mononitrate
Category
Treatment - Drugs
2
Description
25 mg vaginal misoprostol will be administered and will be followed by vaginal placebo