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Comparison of successful induced abortion using misoprostol alone and misoprostol with vaginal estrogen in women candidates for first and second trimester abortions

Protocol summary

Study aim
Comparison of the effect of misoprostol alone and misoprostol with estrogen in successful induced abortion
Design
This three-phase clinical trial, with parallel groups, randomized (using the random allocation rule) is performed on 120 pregnant women.
Settings and conduct
This randomized clinical trial study is performed on 120 pregnant women, in Yas Hospital. The sampling method is a convenience method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother age more than 18 years, gestational age up to 28 weeks, first gravidity, first cesarean section repeat, body mass index between 25 to 35 kg/m2, hemoglobin level more than 10 gr/dL. Criteria for not entering: Scar in the uterine, leiomyoma in the uterine, blood coagulation disorder, previous attempts to induce abortion in the current pregnancy, a medical disorder that prohibits abortion for example heart failure, allergy to misoprostol or estradiol, cervicitis and vaginitis, polyhydramnios and the patient withdrawal to participate in the study.
Intervention groups
In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. In addition, in the intervention group, half of a vaginal estrogen ointment is administered, an hour before misoprostol prescription. Then, vaginal estrogen is administered with misoprostol if needed up to a maximum of three doses.
Main outcome variables
Successful abortion, number of misoprostol doses used, need for curettage or hysterectomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190208042655N2
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
Nafiseh Saedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 0727
Email address
nsaedi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of successful induced abortion using misoprostol alone and misoprostol with vaginal estrogen in women candidates for first and second trimester abortions
Public title
Comparison of successful abortion using misoprostol alone and misoprostol with vaginal estrogen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mother age more than 18 years Gestational age up to 28 weeks First gravidity First cesarean section repeat Body mass index between 25 to 35 kg/m2 Hemoglobin level more than 10 gr/dL
Exclusion criteria:
Scar in the uterine Leiomyoma in the uterine Blood coagulation disorder Previous attempts to induce abortion in the current pregnancy A medical disorder that prohibits abortion for example heart failure Allergy to misoprostol or estradiol Cervicitis and vaginitis Polyhydramnios The patient withdrawal to participate in the study
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 60 letters A and 60 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1274

Health conditions studied

1

Description of health condition studied
The first and second trimester abortions
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion

Primary outcomes

1

Description
Successful abortion
Timepoint
Once, at the end of abortion
Method of measurement
Abortion product observation (placenta and fetus residual)

Secondary outcomes

1

Description
Number of doses of misoprostol used
Timepoint
Once, at the end of abortion
Method of measurement
Counting misoprostol doses

2

Description
Need to surgery
Timepoint
Once, at the end of abortion
Method of measurement
Curettage or hysterectomy conducting

Intervention groups

1

Description
Intervention group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria. In addition, half of a vaginal estrogen ointment is administered, an hour before misoprostol prescription. Then, vaginal estrogen is administered with misoprostol if needed up to a maximum of three doses.
Category
Treatment - Drugs

2

Description
Control group: In women candidates for abortion, misoprostol is prescribed according to FIGO criteria.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Nafiseh Saedi
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
nsaedi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Fotouhi
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Saedi, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Nafiseh Saedi
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Nafiseh Saedi.
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