A comparative study of the effect of evening primrose oil capsule and misoprostol on cervical ripening in pregnant women candidate for termination of pregnancy
A comparative study of the effect of evening primrose oil capsule and misoprostol on cervical ripening in pregnant women candidate for termination of pregnancy
Design
This study is a one-blinded clinical trial. The study population will be included all women candidates for termination of pregnancy referred to Imam Reza Hospital of Kermanshah. Sixty eligible pregnant women will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
The study, which will be conducted at Imam Reza Hospital of Kermanshah, is one-blind one as participants are unaware of the allocation of study groups. After intervention and suppository, the monitor is checked continuously for 1 hour and after 3 hours fetal ECG test is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy amniotic sac; No substance abuse; Mothers with height >150 cm
Exclusion criteria: Known fetal problems
Intervention groups
The intervention group will receive two 500 mg gel capsules into the vaginal posterior fornix. 6-8 hours later, if there is an increase in the Bishop score, the induction is performed and if no change is observed, the intervention protocol with primrose oil will be repeated.
The control group will also receive a misoprostol 25 microgram suppository every 6 hours when the mother'sBishop score is less than 6.
Main outcome variables
Ripening Of Cervix
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N129
Registration date:2019-10-28, 1398/08/06
Registration timing:prospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
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
2019-11-06, 1398/08/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of evening primrose oil capsule and misoprostol on cervical ripening in pregnant women candidate for termination of pregnancy
Public title
Comparison of the effect of evening primrose oil capsule and misoprostol on cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age from (37 completed weeks) to (40 weeks + 6 days) based on the beginning of the last menstrual period and first trimester ultrasound
Natural pattern of fetal heart rate
Healthy amniotic sac
No substance abuse
mothers with height >150 cm
Exclusion criteria:
Known fetal problems
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
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 were kept blind to study groups, drug dosage, and drug manufacturer
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
2019-05-08, 1398/02/18
Ethics committee reference number
ir.kums.rec.1398.709
Health conditions studied
1
Description of health condition studied
Ripening Of Cervix
ICD-10 code
O75.9
ICD-10 code description
Complication of labor and delivery, unspecified
Primary outcomes
1
Description
Ripening Of Cervix
Timepoint
One and three hours after the end of the intervention
Method of measurement
Using Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive two 500 mg gel capsules into the vaginal posterior fornix. 6-8 hours later, if there is an increase in the Bishop score, the induction is performed and if no change is observed, the intervention protocol with primrose oil will be repeated.
Category
Treatment - Drugs
2
Description
The control group will also receive a misoprostol 25 microgram suppository every 6 hours when the mother'sBishop score is less than 6.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mona Zeynolabedin
Street address
Imam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
monazblue@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
Mona Zeynolabedin
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
monazblue@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Jalilian
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
njalilian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mona Zeynolabedin
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
monazblue@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
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
6 month
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