Comparison of the effect of vaginal consumption of primrose oil on the preparation of cervix in term delivery at patient resort to educational hospitals of Medical Sciences
Determining the effect of vaginal consumption of evening primrose oil on cervical preparation in women referred to hospitals of Mashhad University of Medical Sciences
Design
The clinical trial has a control group, with parallel groups, non-blinding, randomized, phase 1 on 76 pregnant women with a full gestational age of 40 weeks. For randomization, a simple randomization divided by days of the week will be used.
Settings and conduct
This study will be performed on a group of women referring to Imam Reza (AS) Hospital in Mashhad. The outcome assessors are unaware of the allocation group and using codes A and B instead of group names.
Participants/Inclusion and exclusion criteria
This study will be performed on a group of women referred due to ethical considerations of without any blinding. Prior to entering the study, participants will receive an informed consent form attached to this study.
Intervention groups
Evening primrose oil capsules will receive up to 6 doses vaginally every 4 to 6 hours a day.
In the control group, only the initial examination is performed.
Main outcome variables
Bishop overall score, subgroups of this scoring system
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201115049389N1
Registration date:2021-01-16, 1399/10/27
Registration timing:registered_while_recruiting
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Mahya Labbafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
labbafchimahya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-09, 1399/08/19
Expected recruitment end date
2021-10-31, 1400/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vaginal consumption of primrose oil on the preparation of cervix in term delivery at patient resort to educational hospitals of Medical Sciences
Public title
Comparison of the effect of vaginal consumption of primrose oil on the preparation of cervix in term delivery at patient resort to educational hospitals of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Low risk of pregnancy
Bishop score less than 4
BMI between 19 and 25
Lack of systemic disease
No drug addiction
No vaginal bleeding
Gain conscious satisfaction
Exclusion criteria:
Patient non-cooperation
Increased risks of delivery
Use other methods of uterine preparation
Diabetes and hypertension
Chronic inflammatory disease
Improper fetal presentation
Age
No age limit
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method by one of the nurses of the relevant ward, who is not aware of the implementation of the study. Random sequences will be generated using the Random Generator program. Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
529 / 5000Translation resultsWe use the Bishop score to check the degree of softening of the cervix. We randomly divide the referring women into two groups, A and B, after completing the informed consent form. We measure demographic information, gestational age, bishop score, last period date, induction delivery interval, mode of delivery, 3rd stage blood loss, and fetomaternal outcome. In both groups, strip is done and one group of primrose oil is blinded on one side. We measure Bishop score, duration of labor, and postpartum hemorrhage, Apgar score 1 and 5 minutes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.459
Health conditions studied
1
Description of health condition studied
Pregnant mothers
ICD-10 code
P03.8
ICD-10 code description
Newborn (suspected to be) affected by other specified complications of labor and delivery
Primary outcomes
1
Description
Bishop score measured
Timepoint
Before interventional and 24 hours after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Evening primrose oil capsules will receive up to 6 doses vaginally every 4 to 6 hours a day.
Category
Treatment - Drugs
2
Description
Control group: They are just examined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Marzieh Lotfalizadeh
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
lotfalizadem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qoreighi Building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Marzieh Lotfalizadeh
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Lotfalizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital. Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Email
lotfalizade@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahya Labbafchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital. Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Email
LabbafchiM961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahya Labafchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital. Imam Reza square.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3854 3031
Email
LabbafchiM961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available