An Outpatient Treatment of comparative study on the efficacy and side effects of oxytocin + misoprostol with methyl ergonovin (metergin) + misoprostol and only misoprostol in the expulsion of first trimester intrauterine fetal dead
Determining the effects of misoprostol alone, oxytocin + misoprostol and methylergonovine (Methergine) + misoprostol on the Excretion of pregnancy products after spontaneous fetal abortion
Design
An Outpatient Therapy Comparison of the Effectiveness and Side Effects of Oxytocin + Misoprostol with Methylergonovine (Methergine)+Misoprostol and Misoprostol alone in the excretion of pregnancy products in patients with fetal death in the first trimester of pregnancy
Settings and conduct
The first group is the control group and only Misoprostol is prescribed for them. Second and third groups will be treated as case or intervention groups with different regimens, which in the second group, Misoprostol and Oxytocin medications, and in the third group, Misoprostol and Methergine medications will be used as a drug regimen.
Jahrom Motahari Hospital
Participants/Inclusion and exclusion criteria
The gestational age should be under 14 weeks.
patients should not have a history of high-risk diseases (diabetes and hypertension, and hematologic disorders and cardiovascular diseases, etc.)
patients should not have willing to undergo outpatient treatment for the excretion of pregnancy products.
exclusion criteria:
In the case of certain diseases, fever and hypertension patients are excluded from the study
Also, patients who do not tolerate medications or get tired of the treatment
Intervention groups
The first group is the control group and only Misoprostol is prescribed for them. Second and third groups will be treated as case or intervention groups with different regimens, which in the second group, Misoprostol and Oxytocin, and in the third group, misoprostol and methergine will be used as the drug regimen.
Main outcome variables
Frequency of success; The remaining tissue size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150407021653N19
Registration date:2019-10-04, 1398/07/12
Registration timing:retrospective
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-26, 1397/07/04
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Outpatient Treatment of comparative study on the efficacy and side effects of oxytocin + misoprostol with methyl ergonovin (metergin) + misoprostol and only misoprostol in the expulsion of first trimester intrauterine fetal dead
Public title
An Outpatient Treatment of comparative study on the efficacy and side effects of oxytocin + misoprostol with methyl ergonovin (metergin) + misoprostol and only misoprostol in the expulsion of first trimester intrauterine fetal dead
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who tend to undergo outpatient treatment for the excretion of pregnancy products.
The gestational age should be under 14 weeks.
Do not have a history of high-risk diseases (diabetes and blood pressure and blood problems and cardiovascular diseases, etc.).
Exclusion criteria:
If there are certain illnesses, fever and blood pressure will be excluded from the study.
patients who do not tolerate drug therapy or will be tired of the treatment
Age
No age limit
Gender
Female
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
Randomization (investigator's opinion)
Randomized
Randomization description
simple Randomization by random numbers table
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 Jahrom University of Medical Sciences
Street address
Motahari hospital, Motahari Street , Jahrom, Iran
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.JUMS.REC.1396.143
Health conditions studied
1
Description of health condition studied
Disposal of pregnancy products After spontaneous abortion
ICD-10 code
O03.4
ICD-10 code description
Incomplete spontaneous abortion without complication
Primary outcomes
1
Description
Success in the pregnancy products excretion
Timepoint
During the 9 days after abortion
Method of measurement
Ultrasonography
2
Description
The remaining tissue size
Timepoint
During the 9 days after abortion
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Determine the mean time for disposal of pregnancy products after spontaneous abortion
Timepoint
After spontaneous abortion
Method of measurement
observation
Intervention groups
1
Description
Intervention group 1: Misoprostol and oxytocin medications are used as a drug regimen.
Category
Treatment - Drugs
2
Description
Intervention group 2: Misoprostol and Methergine medications are used as a drug regimen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Dr. Athar Rasekh Jahromi
Street address
Motahari Hospital , Motahari Street , Jahrom
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 5014
Fax
Email
Drrasekh@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Athar Rasekh Jahromi
Street address
Motahari hospital, Street Motahari, Jahrom
City
jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 0409
Fax
Email
Drrasekh@yahoo.com
Web page address
Grant name
.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Athar Rasekh Jahromi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari hospital, Street Motahari , Jahrom
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 0409
Email
Drrasekh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr.Athar Rasekh jahromi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahrom, Street Motahari, Motahari hospital
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 0409
Email
Drrasekh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Athar Rasekh Jahromi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari hospital, Street Motahari, Jahrom
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 0409
Email
Drrasekh@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
No - There is not 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
Full data of unidentified people will be shared.
When the data will become available and for how long
1398-1399
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Data re-analysis can only be used in the new article if the name of the researchers is given.
From where data/document is obtainable
Calling to receive data through this email will be possible: Drrasekh@yahoo.com
What processes are involved for a request to access data/document
After reviewing the objective, the request for data is provided to the person.