Comparison between effect of vaginal Primrose with Misoprostol on the cervical ripening and dilatation in non-menopausal women without a history of NVD,or menopausal women that are candidates for gynecologic surgeries
Design
The study design based on a randomized double-blind controlled trial ,accomplish with 42 subjects(20-75 years).
Settings and conduct
The study pupolation are at least 42 patients (20-75) that refer to Shohadaye Tajrish hospital Gynecology clinic and are candidates surgeries. By simple randomization method ,21 patients receive 2 soft gels(each 500 mg) of Primrose ,and 21 patients receive 2 tablets (each 200 micro-gram) of Misoprostol.Druges apply to the posterior vaginal fornix،2-4 hours before the surgery.
This study evaluate the total dilatation time,the first Hegar size used to apply force,blood loss,complications drugs side effects .
Participants/Inclusion and exclusion criteria
Study population are 20-75 years old women that are candidates for hysteroscopic surgeries ,D&C,laparoscopic hysterectomy ,and any others need uterine manipulator insertion.
The inclusion criteria
Non-menopausal women without a history of NVD
Menopausal women
The exclusion criteria
Ahistory of NVD
Contraindications for the use of Primrose or Misoprostol
Structural anomalies of cervix(incometency ,Mullerian anomaly)
history of cervical cone biopsy
Intervention groups
Number of 21 patients(at least) of 20-75 years old menopausal patients ,or
premenopausal women without a history of NVD. vaginal administration of2 Primrose 500mg capsules 2hours before the surgery.
Control group:Number of 21 patients with the same characters : vaginal administration of 2 Misoprostol 200 mic tablets,2 hours before the surgery.
Main outcome variables
Total dilatation time
the first Hegar size usde to apply force
Blood loss
Drugs side effects
Surgical complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042673N1
Registration date:2019-04-20, 1398/01/31
Registration timing:prospective
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Behnaz Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7747 1287
Email address
nouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Evening Primrose And Misoprostol On The Cervical Ripening And Dilatation Before Gynecologic Surgeries
Public title
"Effect of Primrose on non-pregnant cervical ripening ""effect of Misoprostol on non-pregnant cervical ripening "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-menopause women without history of previous normal vaginal delivery
Menopause women
Exclusion criteria:
Previous Normal Vaginal Delivery
Structural Cervical Anomaly such as cervical incompetency
Mullerian Anomalies
Previous Cervical Conization
Contraindications of Misoprostol and Primrose
Age
From 20 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization- Computer-generated random numbers select between 0-1acorrding to total sample size (42). Numbers which are less than 0.5 assign of the intervention group and those are greater than 0.5 assign of the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs administrate by resident based on randomization patient's numbers without awareness of both participants and study staff
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Comparison Between Evening Primrose And Misoprostol On The Cervical Ripening And Dilatation Before Gynecologic Surgeries
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
Total cervical dilatation time
Timepoint
From the first Hegar to the tenth Hegar
Method of measurement
Second
2
Description
The first Hegar size used to apply force
Timepoint
During surgery
Method of measurement
Hegar size number
3
Description
Blood loss
Timepoint
Estimated blood loss during surgery
Method of measurement
mililiter
Secondary outcomes
1
Description
Drugs side effects
Timepoint
After administration, 6hand24h
Method of measurement
Observation, Questionaire
2
Description
Complications of surgery
Timepoint
During surgry
Method of measurement
Check list
Intervention groups
1
Description
Intervention group: Non-pregnant women without history of normal vaginal delivery,or menopause women, that need cervical dilation before the surgery.Vaginal administration of 2Primrose capsules 500mg ,2 hours before surgery.
Category
Treatment - Drugs
2
Description
Control group: Non -pregnant women without history of normal vaginal delivery ,or menopause women ,that need cervical dilation before the surgery with vaginal administration 2 Misoprostol tablets 200 mic,2 hours before the surgery.
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
Total cervical dilation time ,size of the first Hegar used to apply force/Blood loss/drugs side effects/complications/type of surgery/menopausal status/age/Gravidity/pariaty/BMI
When the data will become available and for how long
5MONTHES
To whom data/document is available
Researchers /OB&GYN
Under which criteria data/document could be used
FOR RESEARCH AND Clinical utilization
From where data/document is obtainable
DR.Behnaz Nouri
What processes are involved for a request to access data/document