Comparative study of the effect of vaginal isosorbide dinitrate in pre-induction cervical ripening in term pregnancy
Design
This is single blind clinical trial.The study population included all patients referring to Imam Reza hospital in Kermanshah city. A total of 148 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah city. The participants do not know what medicine they will receive, and at the beginning of the study, the vital signs of the participants in both groups are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of previous cesarean section or any uterine scar; single pregnancy.
Exclusion criteria: estimate fetal weight more than 4 kg; labor pain.
Intervention groups
The first intervention group will receive 40 mg of vaginal isosorbide dinitrate within 24 hours.The second intervention group will receive 20 mg of vaginal isosorbide dinitrate within 24 hours.The third intervention group will receive 10 mg of vaginal isosorbide dinitrate within 24 hours.The control group will not receive any intervention.
Main outcome variables
Headache, nausea, blood pressure drop
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N90
Registration date:2018-05-02, 1397/02/12
Registration timing:registered_while_recruiting
Last update:2018-05-02, 1397/02/12
Update count:0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-28, 1397/02/08
Expected recruitment end date
2018-10-30, 1397/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of vaginal isosorbide dinitrate in pre-induction cervical ripening in term pregnancy
Public title
Comparison the effect of vaginal isosorbide dinitrate in pre-induction cervical ripening in term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 37 weeks up to the end of the week
Cephalic presentation
No contraindications for isosorbide dinitrate
Normal body volume index (BMI = 19.8-26),
No history of previous cesarean section or any uterine scar
Exclusion criteria:
The presence of systemic diseases
Estimate fetal weight more than 4 kg
Vaginal bleeding
Intolerance to ISDN, labor pain and oligohydramnios
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be blinded to the study groups, dosage of the drug and the manufacturer of the drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.KUMS.REC.1396.594
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34
ICD-10 code description
Normal pregnancy
Primary outcomes
1
Description
Headache
Timepoint
At the beginning of the study, every 15 minutes to 1 hour, then every 30 minutes to 2 hours, and every 1 hour until delivery
Method of measurement
Ask the patient
2
Description
Nausea
Timepoint
At the beginning of the study, every 15 minutes to 1 hour, then every 30 minutes to 2 hours, and every 1 hour until delivery
Method of measurement
Ask the patient
3
Description
Blood pressure drop
Timepoint
At the beginning of the study, every 15 minutes to 1 hour, then every 30 minutes to 2 hours, and every 1 hour until delivery
Method of measurement
Sphygmomanometer.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 40 mg of vaginal isosorbide dinitrate within 24 hours
Category
Treatment - Drugs
2
Description
The second intervention group will receive 20 mg of vaginal isosorbide dinitrate within 24 hours
Category
Treatment - Drugs
3
Description
The third intervention group will receive 10 mg of vaginal isosorbide dinitrate within 24 hours
Category
Treatment - Drugs
4
Description
The control group will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Fatemeh Poyan
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4601
Email
fatemehpoyan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
fatemeh poyan
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4601
Email
fatemehpoyan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Negin Rezavand
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
NRezavand@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
fatemeh poyan
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3426 4601
Email
fatemehpoyan@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
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail