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Comparison of vaginal misoprostol with and without vaginal estrogen in cervical ripening before operative hysteroscopy in postmenopausal women

Protocol summary

Study aim
Comparison of vaginal misoprostol with and without vaginal estrogen in cervical ripening before operative hysteroscopy in postmenopausal women referring to Rasool-e Akram hospital
Design
Clinical trial with control group, with parallel groups, single blinded, randomized, phase 3 on 102 patients.
Settings and conduct
This study was performed on 102 postmenopausal women who were candidate for hysteroscopy in Rasool-e Akram hospital.Patients were randomly divided into two groups e.i. patients in the intervention group were treated with one third of 4 gr applicator of vaginal cream 0.625 mg estrogen conjugate + misoprostol and control group receive only misoprostol. Patients and statistical analysts were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria were postmenopausal women (at least more than 1 year after the last menstrual cycle), candidates for hysteroscopy and patients must have a normal mammogram and Pap smear within the last 2 years. Exclusion criteria were recent or current pelvic infection, History of cervical conization, Previous surgery on the cervix, hypersensitivity to prostaglandins, History of venous thrombosis, Cardiovascular disease, Cervical or breast malignancies, Mullerian anomaly, Cervical anomalies
Intervention groups
Patients in the intervention group were treated with one third of 4 gr applicator of vaginal cream 0.625 mg estrogen conjugate + misoprostol. Control group receive only misoprostol.
Main outcome variables
Use of resectoscope, cervical softness, cervical stenosis, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211013052756N1
Registration date: 2021-11-05, 1400/08/14
Registration timing: retrospective

Last update: 2021-11-05, 1400/08/14
Update count: 0
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Mahsa Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 4111
Email address
dr.m.kiani87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2021-01-19, 1399/10/30
Trial completion date
2021-04-21, 1400/02/01
Scientific title
Comparison of vaginal misoprostol with and without vaginal estrogen in cervical ripening before operative hysteroscopy in postmenopausal women
Public title
Comparison of vaginal estradiol in cervical ripening with misoprostol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women (at least more than 1 year after the last menstrual cycle) Candidates for hysteroscopy Patients must have a normal mammogram and Pap smear within the last 2 years
Exclusion criteria:
Recent or current pelvic infection History of cervical conization Previous surgery on the cervix hypersensitivity to prostaglandins History of venous thrombosis Cardiovascular disease Cervical or breast malignancies Mullerian anomaly Cervical anomalies
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
Sample size
Target sample size: 102
Actual sample size reached: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization with the permuted block method was used to create the random sequence and balance the number of allocated samples in intervention group (Vaginal misoprostol + estrogen, N=51) and control group (Vaginal misoprostol, N=51). The computer program was used for a random sequence using Excel, Rand function, in blocks of 2, 4, and 6. Each block has an equal number of control and HemoHIM groups. It is written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is unaware of the allocation of drugs because he/she will be anesthetized and the statistical analyzer will receive the groups in the form of codes A and B and is unaware of the type of intervention in the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No8,amani street, shariati street, tehran,iran.
City
Tehran
Province
Tehran
Postal code
۱۹۴۸۶۴۳۴۵۱
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.IUMS.FMD.REC.1398.374

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders

Primary outcomes

1

Description
Hegar cervical dilator during hysteroscopy
Timepoint
One during hysteroscopy
Method of measurement
Observation

Secondary outcomes

1

Description
Cervical softness and stenosis
Timepoint
One during hysteroscopy
Method of measurement
Observation

2

Description
Pain
Timepoint
One 6 hours after hysteroscopy
Method of measurement
Visual analogue scale

Intervention groups

1

Description
Intervention group: Patients in the intervention group were treated with one third of 4 gr applicator of vaginal cream 0.625mg estrogen conjugate (each 1gr contains 0.625 mg conjugated estrogen produced by Aburaihan pharmaceutical Co) for 5 days the week before surgery as daily consumption at home. Also, this group received 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery.
Category
Treatment - Drugs

2

Description
Control group: This group received only 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Co) 6 hours before surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e-akram hospital
Full name of responsible person
Mahsa Kiani
Street address
No 8, Amani street , Shariati street. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۴۸۶۴۳۴۵۱
Phone
+98 21 2286 4111
Email
dr.m.kiani87@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Vice- Chancellor in Research Affairs of Iran University of Medical Sciences, Next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۴۸۶۴۳۴۵۱
Phone
+98 21 2286 4111
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahsa Kiani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 8, Amani street, Shariati street , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1948643451
Phone
+98 21 2286 4111
Email
dr.m.kiani87@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Kiani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 8, Amani street, Shariati street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۹۴۸۶۴۳۴۵۱
Phone
+98 21 2286 4111
Email
dr.m.kiani87@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Kiani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No8, Amani street, Shariati street , Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
۱۹۴۸۶۴۳۴۵۱
Phone
+98 21 2286 4111
Email
dr.m.kiani87@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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