Evaluation and comparison of expectant treatment and drug treatment on retained products of concepton
Design
A controlled, parallel-group, unblinded, non-randomized, phase 2 clinical trial on 124 patients.
Settings and conduct
124 patients are randomly divided into two groups. One group receives drug treatment (600 micrograms of sublingual misoprostol) and the other group receives expectant treatment. The place of study is Mahdia Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients who have informed consent to participate in the study, patients without underlying disease, patients without a history of previous abortion. Exclusion criteria include patients who do not have informed consent to participate in the study, patients with an underlying disease, and patients with a history of previous abortion.
Intervention groups
One group is treated with medication (600 micrograms of sublingual misoprostol) and the other group is treated with expectant treatment.
Main outcome variables
Improvement of menstrual intervals as well as vaginal bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061800N3
Registration date:2024-08-20, 1403/05/30
Registration timing:prospective
Last update:2024-08-20, 1403/05/30
Update count:0
Registration date
2024-08-20, 1403/05/30
Registrant information
Name
shahedeh khansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4643 2157
Email address
b_sh2110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of expectant treatment and drug treatment on retained products of concepton
Public title
Evaluation and comparison of expectant treatment and drug treatment on retained products of concepton
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with no history of previous abortion
Patients without underlying disease
Patients who have informed consent to participate in the study
Exclusion criteria:
Patients with a history of previous abortion
Patients with underlying disease
Patients who do not have informed consent to participate in the study
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
N/A
Randomization description
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 shahid beheshti University of Medical Sciences
Street address
SBUMS, Arabi Ave, th Floor, Bldg No.2, Velenjak, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.SBMU.MSP.REC.1403.177
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
O08
ICD-10 code description
Complications following ectopic and molar pregnancy
Primary outcomes
1
Description
Improvement of menstrual intervals
Timepoint
Every 2 weeks for a maximum of 6 weeks
Method of measurement
Using an ultrasound scan
2
Description
Improvement of vaginal bleeding
Timepoint
Every 2 weeks for a maximum of 6 weeks
Method of measurement
Using an ultrasound scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They are treated with medication (600 micrograms of misoprostol administered sublingually).
Category
Treatment - Drugs
2
Description
Intervention group: They undergo expectant treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiye hospital
Full name of responsible person
Sepideh Ashrafi Vand
Street address
Mahdieh Hospital, Shahrzad Avenue, Shush Square, Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
sashrafivand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar Ave, Daneshju Blvd, Velenjak, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dean.medicalschool@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Ashrafi Vand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
SBUMS, Arabi Ave, th Floor, Bldg No.2, Velenjak, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
sashrafivand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Ashrafi Vand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
SBUMS, Arabi Ave, th Floor, Bldg No.2, Velenjak, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
sashrafivand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Ashrafi Vand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
SBUMS, Arabi Ave, th Floor, Bldg No.2, Velenjak, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
sashrafivand@yahoo.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All individual data of the participants in this study will be shared after unidentifiable individuals
When the data will become available and for how long
The access period will start from 2023 to 2024
To whom data/document is available
All individual data of the participants in this study will be shared after unidentifiable individuals
Under which criteria data/document could be used
Just for performing research
From where data/document is obtainable
To access the data, one should contact the responsible person, Dr. Sepideh Ashrafi Vand. For this purpose, it is better to contact sashrafivand@yahoo.com and phone number +98 21 5506 2628 to access the data.
What processes are involved for a request to access data/document
To access the data, one should contact the responsible person, Dr. Sepideh Ashrafi Vand. For this purpose, it is better to contact sashrafivand@yahoo.com and phone number +98 21 5506 2628 to access the data. The duration of data access is approximately one week after making the call.