To Investigate the possible effect of progesterone Supp on cytokines endocervical concentration of women at risk of abortion.In a clinical randomized trial of 100 prime-gravid women at risk of abortion less than 20 weeks of gestation, cervical fluids were collected. Pregnant women with sign and symptoms of threatened abortion like bleeding, abdominal pain and induction of cervical secretion where included in this study. Lack of satisfaction, hypertension and avoidance of participating in the study were considered as exclusion criteria. Endocervical concentration of inflammatory cytokines were analyzed before and after progesterone treatment for evaluation of cytokine concentration. Wilcoxon and Mann-Whitney tests were employed for statistical analysis. χ2 and Student’s t tests were used if needed. The cytokines concentration were determined with standard Eliza kites .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012035294N1
Registration date:2012-03-17, 1390/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Pouya Javadian
Name of organization / entity
Tehran Universtity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 3641
Email address
hantoushzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2006-06-22, 1385/04/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the possible effect of Progesterone Supp on cytokines endocervical concentration of women at risk of abortion
Public title
Progesterone effect on threatened abortion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women less than 20 weeks of gestation with sign and symptoms of threatened abortion like bleeding, abdominal pain and induction of cervical secretion where included in this study; Exclusion criteria: Lack of satisfaction, hypertension and avoidance of participating in the study were considered as exclusion criteria.
Age
From 16 years old to 44 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Research committee in Hamdan University of Medical Sciences
Street address
Medical University of Hamadan, Bouali Sina Street
City
Hamadan
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
1-3-10-5-25-12
Health conditions studied
1
Description of health condition studied
abortion
ICD-10 code
P01.8
ICD-10 code description
Fetus and newborn affected by other maternal complications of pregnancy Spontaneous abortion, fetus
Primary outcomes
1
Description
incidence of abortion
Timepoint
at the end of study
Method of measurement
due to definition, fetal weight less than 500 grams and delivery before 20 weeks
Secondary outcomes
1
Description
study the inflammatory cytokines of cervix
Timepoint
before and after treatment
Method of measurement
special kits & Eliza
Intervention groups
1
Description
Placebo suppository
Category
Placebo
2
Description
Progesterone suppository
400 mg twice daily for a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr.Sedigheh Hantoushzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Vice chancellor for research, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Vali-e-Asr Square, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice chancellor for research, Imam Khomeinei Hospital
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Vali-e-Asr Hospital, Tehran University of Medical Sciences, Bagher Khan Street, Shahid Chamran High way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Imam Khomeinei Hospital
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Vali-e-Asr Hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr.Sedigheh Hantoushzadeh
Position
Associate Professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Vali-e-Asr Hospital, Tehran University of Medical Sciences, Bagher Khan Street, Shahid Chamran High way,Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 127 1209
Fax
Email
hantoushzadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-e-Asr Hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr.Sedigheh Hantoushzadeh
Position
Associate Professore of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Vali-e-Asr Hospital, Tehran University of Medical Sciences, Bagher Khan Street, Shahid Chamran High way,Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 127 1209
Fax
Email
hantoushzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali-e-Asr Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr.Pouya Javadian
Position
General Pratctitioner
Other areas of specialty/work
Street address
Vali-e-Asr Hospital, Tehran University of Medical Sciences, Bagher Khan Street, Shahid Chamran High way,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6658 1617
Fax
Email
pouyajavadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)