A comparative study of vaginal hyoscine butyl bromide and misoprostol on cervical ripening for gynecological intrauterine procedures
Design
The clinical trial, with parallel groups, randomized, Double blind, single-center trial, sample size 50 people.
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group.
Drug packaging is coded. So that the evaluators and patients are unaware of the drug content packaging and intervention that they receive.
Settings and conduct
Amir Al-Momenin Hospital.
Hyoscine butylbromide oral tablet (40 mg dose) and misoprostol (200µg) is inserted vaginally into the posterior cervical region 2 hours before the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 55 years; Before menopause.
Exclusion criteria: Pregnancy; History of more than 3 deliveries; Anatomic abnormalities in the genital tract; Infection or wound visible in the cervix or vagina.
Intervention groups
Intervention group: Hyoscine butylbromide oral tablet (40 mg dose) is inserted vaginally into the posterior cervical region 2 hours before the intervention.
Control group: Misoprostol (200µg) is inserted vaginally into the posterior cervical region 2 hours before the intervention.
Main outcome variables
Cervical diameter; The amount of pain; Bleeding rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N68
Registration date:2021-05-25, 1400/03/04
Registration timing:registered_while_recruiting
Last update:2021-05-25, 1400/03/04
Update count:0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of vaginal hyoscine butyl bromide and misoprostol on cervical ripening for gynecological intrauterine procedures
Public title
A comparative study of vaginal hyoscine butyl bromide and misoprostol on cervical ripening for gynecological intrauterine procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 years
Before menopause
Exclusion criteria:
Pregnancy
History of more than 3 deliveries
Anatomic abnormalities in the genital tract
Infection or wound visible in the cervix or vagina
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug packaging is coded. So that the evaluators and patients are unaware of the drug content packaging and intervention that they receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.SEMUMS.REC.1399.324
Health conditions studied
1
Description of health condition studied
Intrauterine interventions
ICD-10 code
Z01.4
ICD-10 code description
Encounter for gynecological examination
Primary outcomes
1
Description
Cervical diameter
Timepoint
Before and after the intervention
Method of measurement
The largest size of Hegar dilator that can be inserted without resistance and easily.
2
Description
The amount of pain
Timepoint
Before and after the intervention
Method of measurement
Visual analogue scale for pain (0 to10)
3
Description
Bleeding rate
Timepoint
Before and after the intervention
Method of measurement
Cylindrical (cc)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hyoscine butylbromide oral tablet (40 mg dose) is inserted vaginally into the posterior cervical region 2 hours before the intervention.
Category
Diagnosis
2
Description
Control group: Misoprostol (200µg) is inserted vaginally into the posterior cervical region 2 hours before the intervention.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Shahrzad Aghaamoo
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Shahrzad Aghaamoo
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Shahrzad Aghaamoo
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahshid Khakzad
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available