Comparative study of the effect of vaginal consumption of primrose oil with vaginal misoprostol on cervical preparation in nulliparous women with prolonged pregnancy
Comparative study of the effect of vaginal consumption of primrose oil with vaginal misoprostol on cervical preparation in nulliparous women with prolonged pregnancy
Design
Clinical trial without control group with parallel, randomized, phase 3 groups on 110 patients A random number table was used for randomization.
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients are randomly divided into two groups. Patients are treated with misoprostol or primrose oil according to their group. The rate of effusion and uterine dilatation in pregnant women will be measured and compared every 10 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Duration of pregnancy 40 weeks and more, Primiparous women, Single delivery, Satisfaction to participate in the study
Exclusion criteria: The patient refuses to continue attending the study for various reasons, Patient discharge with personal consent
Intervention groups
Intervention group 1: Patients in this group are treated with a quarter of 500 mg misoprostol vaginal tablets. The rate of Effacement and uterine dilatation in pregnant women is measured every 10 minutes by a physical exams.
Intervention group 2: Patients in this group are treated with 1000 mg vaginal capsule of primrose oil. The rate of Effacement and uterine dilatation in pregnant women is measured every 10 minutes by a physical exams.
Main outcome variables
Uterine dilatation rate, Effacement percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N14
Registration date:2021-04-20, 1400/01/31
Registration timing:prospective
Last update:2021-04-20, 1400/01/31
Update count:0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-29, 1400/02/09
Expected recruitment end date
2021-05-30, 1400/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of vaginal consumption of primrose oil with vaginal misoprostol on cervical preparation in nulliparous women with prolonged pregnancy
Public title
The effect of vaginal consumption of evening primrose oil on cervical preparation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Duration of pregnancy 40 weeks and more
Primiparous women
Single delivery
Satisfaction to participate in the study
Age between 18- 35 years
Exclusion criteria:
The patient refuses to continue attending the study for various reasons
Patient discharge with personal consent
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
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 IsfahanUniversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-09-25, 1399/07/04
Ethics committee reference number
IR.MUI.MED.REC.1399.530
Health conditions studied
1
Description of health condition studied
Prolonged first stage (of labor)
ICD-10 code
O63.0
ICD-10 code description
Prolonged first stage (of labor)
Primary outcomes
1
Description
Uterine dilatation rate
Timepoint
Every 10 minutes
Method of measurement
Physical examination
2
Description
Effacement percentage
Timepoint
Every 10 minutes
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group are treated with a quarter of 500 mg misoprostol vaginal tablets. The rate of Effacement and uterine dilatation in pregnant women is measured every 10 minutes by a physical exams.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group are treated with 1000 mg vaginal capsule of primrose oil. The rate of Effacement and uterine dilatation in pregnant women is measured every 10 minutes by a physical exams.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Azar Danesh Shahraki
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
danesh@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azar Danesh Shahraki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
danesh@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azar Danesh Shahraki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
danesh@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azar Danesh Shahraki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
danesh@med.mui.ac.ir
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.