the effect of micronized progesterone and progesterone suppository on pregnancy survival compars in pregnant women threatened with abortion.
Design
Two parallel groups randomized trial, not blinded, single center
Settings and conduct
160 pregnant women threatened with abortion from kowsar hospital which were satisfied to participate in the study were selected and randomly allocated in one of the groups A and B. For the A group micronized progesterone was prescribed and for the group B progesterone suppository was prescribed.
Participants/Inclusion and exclusion criteria
6 to 13 weeks Gestational age , Appearance of fetal heart rate, uterine bleeding, Closed uterine orifice
;Having embryonic or uterine anomalies in ultrasound, not appearancing of fetal heart rate, multi fetal, Hydatidiform mole, A known underlying disease in mother, patients who have been treated by a specific medication to treat abortion
Intervention groups
to one group progesterone suppository is given 400 milligrams per day and to the other group 100 milligrams of progesterone capsule is given per day.
Main outcome variables
Pregnancy residues ;pre term delivery ; complications of post consumption of medicines.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N9
Registration date:2019-05-12, 1398/02/22
Registration timing:retrospective
Last update:2019-05-12, 1398/02/22
Update count:1
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Micronized Progesteron and Progesteron supository on pregnancy residues in mothers who are at risk of abortion
Public title
Comparison of the effect of two progesteron drugs in protection of abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 6 to 13 weeks
Apearance of fetal heart rate
Uterine bleeding
Closed uterine orifice
Exclusion criteria:
Having embryonic or uterine anomalies in ultrasound
Multi fetal
Hydatidiform mole
A known underlying disease in mother
Patients who have been treated by a specific medication to treat abortion
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Medications are encoded in separate envelopes and delivered to the participants.
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 Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.QUMS.REC.1396.498
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Abortion
Timepoint
From the start of the intervention to the 20th week of pregnancy
Method of measurement
Weekly visit
Secondary outcomes
1
Description
Preeclampsia
Timepoint
Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
Method of measurement
Mercury pressure gauge
2
Description
Gestational Diabetes
Timepoint
Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
Method of measurement
Glucose tolerance test
Intervention groups
1
Description
Intervention group: Progesterone suppository 400 milligrams per day
Category
Treatment - Drugs
2
Description
Intervention group: Progesterone capsule 100 mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Hamide pakniat
Street address
Taleghani Blvd, Valiasr
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3333 6001
Email
pakniat110@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
hpakniat@qums.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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
Starting 1 years after publication .
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Hamideh Pakniat executor of plan
What processes are involved for a request to access data/document
The email will be submitted to the project promoter at the discretion of the information.