comparative evaluation of the effect of vaginal misoprostol to vaginal misoprostol with nitroglycerine in cervix rippening in pregnant women at term referred to Kowsar hospital of Qazvin province
comparative evaluation of the effect of vaginal misoprostol to vaginal misoprostol with nitroglycerine in cervix rippening in pregnant women at term
Design
Randomized clinical trial, Parallel.
Settings and conduct
Participants of the study included 106 pregnant women aged more than 37 weeks who were admitted to Kosar Hospital and were randomly assigned to one of the two groups of single and double dose drugs (each group is 53 patients). For the single-dose group, misoprostol is given at a dose of 25 micrograms vaginal and for group two, misoprostol is given with a dose of 25 micrograms vaginal, with nitroglycerin 40 mg vaginal. Then, patients are evaluated for the purpose of cervical preparation.
Participants/Inclusion and exclusion criteria
Major entry criteria: Primigravida; Gestational age higher than 37 weeks; Bishop score more than 4
Major no- entry criteria: Surgery on the uteus or previous cesarean section; chronic hypertension and preeclampsia
Intervention groups
First intervention group: In the dual drug group, misoprostol is given at a dose of 25 micro grams vaginal with nitroglycerin 40 mg vaginal and after 6 hours, the cervix is examined for Bishop Score, and in the case of inappropriate cervix, 25 micrograms of the next misoprostol is administered up to a maximum of 4 doses.
Second intervention group: In the single dose group, misoprostol is given with a dose of 25 micrograms of vaginal and after 6 hours, the cervix is examined for Bishop Score in case of inappropriate cervix, 25 micro grams of misoprostol is administered up to a maximum of 4 doses.
Main outcome variables
The duration of cervical ripening until delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120428009576N4
Registration date:2020-02-03, 1398/11/14
Registration timing:retrospective
Last update:2020-02-03, 1398/11/14
Update count:0
Registration date
2020-02-03, 1398/11/14
Registrant information
Name
Ezzatsadat Haji seyed javadi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3223 6374
Email address
ehajiseyedjavadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluation of the effect of vaginal misoprostol to vaginal misoprostol with nitroglycerine in cervix rippening in pregnant women at term referred to Kowsar hospital of Qazvin province
Public title
comparative evaluation of the effect of misoprostol vaginal suppository to vaginal misoprostol with nitroglycerine in rippening of cervix in term pregnancy reffered to kowsar hospital
Surgery on the uteus or previous cesarean section
chronic hypertension and preeclampsia
uterine contractions
The presence of heart, kidney and liver disease
rapture of membrane
IUGR
Suspected embryonic anomalies
chorioamnionitis
Fever above 38 ° C
polyhydramnios
Pre-delivery hemorrhage
fetal distress
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to randomized groups based on the demographic data and then divided into two groups. The paired numbers are then assigned to the misoprostol group and the individual numbers to the misoprostol group together with nitroglycerin. Then by moving one of the numbers, we move in a predetermined direction.
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.QUMS.REC.1397.035
Health conditions studied
1
Description of health condition studied
Ripening cervix
ICD-10 code
-
ICD-10 code description
Primary outcomes
1
Description
The duration of cervical ripening until delivery
Timepoint
6 and 12 hours
Method of measurement
Vaginal exam
Secondary outcomes
1
Description
Duration of taking the drug until the onset of the active phase of labor
Timepoint
every 2 hours
Method of measurement
Vaginal exam
2
Description
Duration of taking drug until delivery
Timepoint
every 2 hours
Method of measurement
Vaginal exam
3
Description
Duration of the fist phase of labor
Timepoint
every 2 hours
Method of measurement
Vaginal exam
4
Description
Duration of the second phase of labor
Timepoint
every 1 hours
Method of measurement
Vaginal exam
5
Description
Reach to vaginal delivery
Timepoint
After delivery
Method of measurement
Date sheet
6
Description
Type of delivery
Timepoint
After delivery
Method of measurement
Date sheet
Intervention groups
1
Description
First intervention group: In the dual drug group, misoprostol is given at a dose of 25 micro grams vaginal with nitroglycerin 40 mg vaginal and after 6 hours, the cervix is examined for Bishop Score, and in the case of inappropriate cervix, 25 micrograms of the next misoprostol is administered up to a maximum of 4 doses.
Category
Treatment - Drugs
2
Description
Second intervention group: In the single dose group, misoprostol is given with a dose of 25 micrograms of vaginal and after 6 hours, the cervix is examined for Bishop Score in case of inappropriate cervix, 25 micro grams of misoprostol is administered up to a maximum of 4 doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Maryam Rafiee
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 21 3223 6378
Email
dr_seidjavadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3333 6001
Email
dr_seidjavadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Rafiee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1317634156
Phone
+98 28 3333 6001
Email
dr_seidjavadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ezzatsadat Hajseyedjavadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1317634156
Phone
+98 28 3333 6001
Email
dr_seidjavadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
مریم رفیعی
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
4321102589
Phone
+98 28 3223 6374
Email
dr_seidjavadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Ezzatsadat Hajseyyedjavadi
What processes are involved for a request to access data/document
The email will be submitted to the project promoter at the discretion of the information.