This is a randomized clinical trial to evaluate the effect of administering progesterone to reduce premature labor in women at high risk.
This study was done on 56 pregnant women between 26 to 34 weeks, who were at the risk of premature labor that visited by doctor or clinic Hospital. At the beginning of the study 6 patients were excluded from the study due to fetal abnormalities, preeclampsia, and sensitivity to progesterone.
Then patients were Inclusion criteria, randomly divided into two 25 person groups (experiment and control group).
Inclusion criteria are including cervical insufficiency, history of premature labor and uterine abnormalities.
In the first visit their vaginal discharge were considered about trichomona, gardenella, B streptococus and gonorrhea, and treated.
In the experiment group progesterone supp (200mg) was prescribed
every 2days until the end of 34 week of pregnancy. In the control group tab salbutamole (2mg TID) was prescribed until the end of 34 week of pregnancy. The patients continued treatment outpatient at home and referred for following up pregnancy and contractions (every 2 weeks).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108286808N2
Registration date:2012-02-04, 1390/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-04, 1390/11/15
Registrant information
Name
Maryam Tolyat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 9056
Email address
tolyatm@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Science
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2010-02-04, 1388/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Progesterone by vaginal suppository and betamimetics to reduce preterm birth in women at risk
Public title
effects of Progesterone by vaginal suppository to reduce preterm birth in women at risk
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: cervical insufficiency, history of premature labor and uterine abnormalities.
Exclusion criteria :
fetal abnormalities, preeclampsia, and sensitivity to progesterone
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
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
Birjand University of Medical Science
Street address
Ghafarie street, Birjand
City
Birjand
Postal code
Approval date
2008-09-22, 1387/07/01
Ethics committee reference number
517
Health conditions studied
1
Description of health condition studied
Preterm delivery
ICD-10 code
(O00-O99)
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Number of days delay in delivery of prescribed suppositories
Timepoint
during labor
Method of measurement
Counting the days
Secondary outcomes
empty
Intervention groups
1
Description
In the case group Progesterone supp was administrated every 2days until the end of 34 week of pregnancy.
Category
Treatment - Drugs
2
Description
In the control group betamimetics (syrp. Or tab salbutamol or tab isoxoprin) until the end of 34 week of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Science
Full name of responsible person
Mahboobeh Zangouie
Street address
Birjand University of Medical Science
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Gholamreza Sharifzaadeh
Street address
Birjand University of Medical Science
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Science
Proportion provided by this source
100
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
Birjand University of Medical Science
Full name of responsible person
Mohammad Hasan Namaaie
Position
PhD Microbiology
Other areas of specialty/work
Street address
Birjand University of Medical Science
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
mhnamaei@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Mahboobeh Zangouie
Position
Gynecologist
Other areas of specialty/work
Street address
Birjand University of Medical Science
City
Birjand
Postal code
Phone
+98 56 1444 3000
Fax
Email
m.zanghouee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Mahboobeh Zangouie
Position
Gynecologist
Other areas of specialty/work
Street address
Birjand University of Medical Science
City
Birjand
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)