Comparison of vaginal misoprostol with oral misoprostol in cervical priming before hystroscopic surgery in postmenopausal women and perimenopausal women without history of Normal Vaginal Delivery.
For comparison of vaginal misoprostol with sublingual misoprostol in cervical ripening before operative hysteroscopy in perimenopausal women without history of normal vaginal delivery and postmenopausal women : 120 patients with suspected intrauterine pathology who are candidate for operative hysteroscopy will be included in the study. They are randomly allocated in three groups: The first group receive 400 microgram misoprostol vaginally 10_12 hours before operation. The second group receive 400 microgram misoprostol sublingually 10_12 hours before operation and the third group receive no medication.Cervical width, number of patients needed cervical dilatation,duration of dilatation,operation time and complications are compared in the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204308588N6
Registration date:2012-06-14, 1391/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-14, 1391/03/25
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaginal misoprostol with oral misoprostol in cervical priming before hystroscopic surgery in postmenopausal women and perimenopausal women without history of Normal Vaginal Delivery.
Public title
Effect of misoprostol in Cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:menopausal women and perimenopausal women without history of normal vaginal delivery;who are not pregnant at the time of examination; do not have contraindications for prostaglandins(severe asthma, glaucoma, cardiac disease, hypertension or renal failure); do not have severe uterovaginal prolapse; do not have history of cervical surgery or cervical incompetency.Exclusion criteria: history of normal vaginal delivery in perimenopausal women;pregnancy; have contraindications for prostaglandins(severe asthma, glaucoma, cardiac disease, hypertension or renal failure); have severe uterovaginal prolapse;have history of cervical surgery or cervical incompetency.
Age
From 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical science
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-04-14, 1391/01/26
Ethics committee reference number
14736
Health conditions studied
1
Description of health condition studied
operative Hystroscopic Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical Width
Timepoint
10-12 hours after intervention
Method of measurement
by surgeon during operation
Secondary outcomes
1
Description
Time of Dilatation
Timepoint
10-12 hours after Intervention
Method of measurement
By surgeon during operation
Intervention groups
1
Description
400 micro gram Vaginal misoprostol
10-12 hours before surgery
Category
Treatment - Drugs
2
Description
400 Microgram sublingual 10-12 hours before surgery.