First step in prevention of preterm delivery is early detection of high risk women. Risk factors of preterm labor birth are: history of preterm labor birth, incompetent cervix and having cerclage, uterine anomalies. Thus we are going to determine if progesterone (vaginal suppository, 400 mg) as a maintenance tocolytic can prevent preterm labor birth in 100 women who are high risk for preterm labor birh and compare the neonatal outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012273386N2
Registration date:2011-04-03, 1390/01/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-03, 1390/01/14
Registrant information
Name
Azam Azargoon
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 3401
Email address
a-azargoon@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal progesterone on prevention of preterm delivery and neonatal side effects in women at risk for preterm birth
Public title
Effect of vaginal progesterone on prevention of preterm delivery and neonatal side effects in women at risk for preterm birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: history of preterm labor birth (having at least one delivery before 37 wks of gestational age), incompetent cervix and having cerclage, uterine anomalies (septate uterus. unicornuate or bicornuate). exclusion: clinical evidence of chorioamnionitis, contraindication to use of progesterone (allergy to progesterone products, Diabetes, hypertension, hyperthyroidism, heart disease, polyhydramniose. IUGR, multiple pregnancy.
Age
From 16 years old to 37 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
Semnan University of Medical Sciences
Street address
Basij square
City
Semnan
Postal code
3519899951
Approval date
2010-12-09, 1389/09/18
Ethics committee reference number
3/1/12225
Health conditions studied
1
Description of health condition studied
Preterm Labor Birth
ICD-10 code
O60.1
ICD-10 code description
Preterm labour with preterm delivery
Primary outcomes
1
Description
Preterm Labor Birth
Timepoint
From 16 week to 34 week
Method of measurement
Delivery
Secondary outcomes
1
Description
Necrotising Entrocolitis
Timepoint
After Birth
Method of measurement
NICU records
2
Description
Intra Cranial Haemorrhage
Timepoint
After Birth
Method of measurement
NICU records
3
Description
Weight less than 2500 g
Timepoint
After Birth
Method of measurement
scale
Intervention groups
1
Description
Vaginal suppositories are given as Placebo in control group
Category
Placebo
2
Description
Suppositories of vaginal Progesterone 400 mg are given in intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hospital
Full name of responsible person
Dr Raheb Ghorbani
Street address
Emam Hosein square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Basij square
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Dr Azam Azargoon
Position
Obstetrics & Gynecology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij square
City
Semnan
Postal code
3519899951
Phone
+98 23 1444 0225
Fax
+98 23144451346
Email
a-azargoon@sem-ums.ac.ir
Web page address
htpp://mail.sem-ums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Azam Azargoon
Position
Obstetrics & Gynecology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij square
City
Semnan
Postal code
3519899951
Phone
+98 23 1444 0225
Fax
+98 23144451346
Email
a-azargoon@sem-ums.ac.ir
Web page address
htpp://mail.sem-ums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Azam Azargoon
Position
Obstetrics & Gynecology
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij square
City
Semnan
Postal code
3519899951
Phone
+98 23 1444 0225
Fax
+98 23144451346
Email
a-azargoon@sem-ums.ac.ir
Web page address
htpp://mail.sem-ums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)