Comparative study of efficacy and complications of two cervical preparations in term and preterm pregnancies
Design
This study is a non-blinded clinical trial. The study population will be all pregnant women referred to the gynecology ward of Imam Reza hospital in Kermanshah. 50 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study will be conducted at Imam Reza hospital of Kermanshah. At the beginning of the study, variables of age, gestational age, body mass index and level of education will be examined for the similarity between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother age between 18-35 years; No medical diseases such as diabetes, heart disease, pulmonary, renal disease, hypertension and history of hospitalization due to mental illness; Body mass index less than 26
Exclusion criteria: Indication for termination of pregnancy; Use oxytocin before and during the first contraction monitor; Cesarean section for some reason except for stopping delivery or pelvic stenosis.
Intervention groups
In the first intervention group, oxytocin will be injected simultaneously with the balloon inserted at the appropriate position. In the second intervention group, oxytocin will be injected after balloon withdrawal. In both groups, injections will be started at 2 mu/min oxytocin and continue every 30 minutes with 2 mu/min until delivery.
Main outcome variables
Postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N137
Registration date:2020-02-05, 1398/11/16
Registration timing:registered_while_recruiting
Last update:2020-02-05, 1398/11/16
Update count:0
Registration date
2020-02-05, 1398/11/16
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
2020-01-15, 1398/10/25
Expected recruitment end date
2020-06-14, 1399/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of efficacy and complications of two cervical preparations in term and preterm pregnancies
Public title
Comparative study of efficacy and complications of two cervical preparations in term and preterm pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mother age between 18-35 years
Lack of medical diseases such as diabetes, heart disease, pulmonary, renal disease, hypertension and history of hospitalization due to mental illness
Body mass index less than 26
Exclusion criteria:
Indication for termination of pregnancy
Use oxytocin before and during the first contraction monitor
Cesarean section for some reason except stopping delivery or pelvic stenosis
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
Using the random number table, patients are divided into two groups of 53. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.KUMS.REC.1398.939
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34
ICD-10 code description
Encounter for supervision of normal pregnancy
Primary outcomes
1
Description
Postpartum hemorrhage
Timepoint
After the end of the study
Method of measurement
Based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, oxytocin will be injected simultaneously with the balloon inserted at the appropriate position. Injections will be started at 2 mu/min oxytocin and continue every 30 minutes with 2 mu/min until delivery.
Category
Treatment - Drugs
2
Description
In the second intervention group, oxytocin will be injected after balloon withdrawal. Injections will be started at 2 mu/min oxytocin and continue every 30 minutes with 2 mu/min until delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam Fatahi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
rezaei120alireza@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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
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
Maryam Fatahi
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 6306
Email
rezaei120alireza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zanganeh
Position
Member of Kermanshah University of Medical Sciences
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 6306
Email
mzangeneh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Fatahi
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 6306
Email
rezaei120alireza@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Analytic Code
Not applicable
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
3 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