Evaluation of the effect of black cohosh root with misoprostol on cervical preparation before hysteroscopy in postmenopausal women
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups.
Settings and conduct
66 patients were included in the study and randomly divided into two groups of 33 people. In all patients before and after the operation, the pain level is measured based on the VAS scale. The first group takes 200 micrograms of misoprostol 6-8 hours before the operation.
And the second group will receive 80 mg of black cohosh in addition to 200 micrograms of misoprostol 6-8 hours before the operation.
Participants/Inclusion and exclusion criteria
Post-menopausal women who, according to the definition, have passed their last period for more than 1 year and are candidates for elective hysteroscopy due to post-menopausal bleeding (polyp, myoma or endometrial thickening).
Intervention groups
The first group takes 200 micrograms of misoprostol 6-8 hours before the operation.
And the second group will receive 80 mg of black cohosh in addition to 200 micrograms of misoprostol 6-8 hours before the operation.
Main outcome variables
cervix rippening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230318057754N1
Registration date:2024-01-24, 1402/11/04
Registration timing:prospective
Last update:2024-01-24, 1402/11/04
Update count:0
Registration date
2024-01-24, 1402/11/04
Registrant information
Name
Athena Behforouz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 3664
Email address
behforouz.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the combined effect of black cohosh and misoprostol on the rippening cervix prior to hysteroscopy in postmenopausal women
Public title
Comparative study of the combined effect of black cohosh and misoprostol on the rippening cervix prior to hysteroscopy in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-menopausal women who, according to the definition, have passed their last period for more than 1 year and are candidates for elective hysteroscopy due to post-menopausal bleeding (polyp, myoma or endometrial thickening).
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
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
Disorders of endocrine glands in diseases classified elsewhere
Primary outcomes
1
Description
cervix rippening
Timepoint
Before and after surgery
Method of measurement
Patient response based on Visual Analogue Scale (VAS) score
2
Description
Complications of hysteroscopy including bleeding and pain
Timepoint
Before and after surgery
Method of measurement
Patient response based on Visual Analogue Scale (VAS) score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6-8 hours before the operation, in addition to 200 micrograms of misoprostol (Samisaz Pharmaceutical Company), they will receive 80 mg of black cohosh (Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences). Medicines are used vaginally and a single dose is used.
Category
Treatment - Drugs
2
Description
Control group: take 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) 6-8 hours before surgery. Medicines are used vaginally and one dose is used.