Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy: A Double-Blind Randomized Placebo Controlled Clinical Trial
Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy
Design
Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 126 patients. Block method was used for randomization
Settings and conduct
A randomized double blind clinical trial study was performed in Golestan province, Gorgan, Sayad Shirazi Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Based on the indications for hysteroscopy
Exclusion criteria :
Contraindications to anti-prostaglandin drugs (asthma, or glaucoma)
Women who are contraindicated in hysteroscopy (pregnancy, inflammatory bowel diseas
Intervention groups
Group A, misoprostol 400 microgram tablets vaginally (2 pieces 200 micrograms) and B6 tablets orally (2 pieces), for group B, B6 tablets vaginally (2 pieces) and misoprostol 400 mg tablets orally (2 pieces 200 micrograms) )
Main outcome variables
Cervical Ripening in Women Before Operative Hysteroscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220102053602N1
Registration date:2022-03-16, 1400/12/25
Registration timing:prospective
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
Atefeh Mehralitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 765 0164
Email address
atefehfiroz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy: A Double-Blind Randomized Placebo Controlled Clinical Trial
Public title
Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Based on the indications for hysteroscopy
Exclusion criteria:
Contraindications for anti-prostaglandin drugs (asthma, or glaucoma)
Women who are contraindicated for hysteroscopy (pregnancy, inflammatory bowel disease, malignancy)
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
To perform randomization in the samples, we use the block method with six blocks.
From the following blocks, we first select one at random and divide the samples into 3 groups according to the order.
(A for the vaginal group and B for the oral group and C for the placebo group)
C C B B A A 1
A C C B B A 2
A A C C B B 3
B A A C C B 4
B B A A C C 5
C A A B B C 6
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients and physicians evaluating the interventions designed in the study or the consequences after the procedure (gynecology assistant and gynecological laparoscopic surgery fellowship) will not be aware of the group in which the patient is being examined. All interventions in all three groups will be designed similarly and the process will be the same on all samples in all groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-10-03, 1400/07/11
Ethics committee reference number
IR.GOUMS.REC.1400.253
Health conditions studied
1
Description of health condition studied
Cervical Ripening
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified