Background and aim: preterm birth is the leading cause of perinatal morbidity and mortality worldwide. The administration of progesterone and related compounds has been purposed as a strategy to prevent preterm birth. The objective of this trial was to determine comparison of preterm labor rate in high risk women for preterm labor who used 17-α-OH-p (porloton) IM and vaginal suppository progesterone. We used a randomized single blind study that included 100 high risk pregnancies for preterm labor (history of PTL, recurrent abortion , …..). Women were randomly assigned in two groups who used 17-α-OH-p (proloton) IM weekly or 100 mg of vaginal suppository for two weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012155401N1
Registration date:2011-12-03, 1390/09/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-03, 1390/09/12
Registrant information
Name
Zahara Sabokro
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 0247
Email address
z.sabokro@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2011-01-02, 1389/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Preterm Labor Rate in using Proloton and Vaginal Suppository Progestrone in High Risk Pregnancies
Public title
Comparison of two drugs for Preterm Labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all high risk women for pre-term labour including: recurrent abortion, pre tem labour history, cervical rippening, etc. Exclusion criteria: Epileptic and asthmatic subjects; those with uncontrolled diabetes; those who were sensitive to progesterone; those who have received progesterone four weeks before the study; mental illness; chronic HTN; active liver disorder; HIV infection or 35> CD4 count and anti-viral drug recipients; placenta previa; history of genital and breast cancer; history of thromboembolic disease and mullerian anomaly; ultrasound diagnosed major anomaly; recognized fetal chromosomal abnormalities; Multiple cerclage and preterm labor and PROM and clinical chorioamnionitis; vaginal bleeding and history of spontaneous preterm labor without delivery (including preterm labor).
Age
From 18 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan university of medical sciences
Street address
Daneshgah cross road
City
Hamadan
Postal code
24118/9/35/16/پ
Approval date
2010-05-11, 1389/02/21
Ethics committee reference number
پ/16/35/9/24118
Health conditions studied
1
Description of health condition studied
preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
preterm labor
Timepoint
monthly
Method of measurement
questionnaire and physical exam
Secondary outcomes
1
Description
delivery type
Timepoint
monthly
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention: 17-α-OH-p (proloton), IM, weekly
Category
Treatment - Drugs
2
Description
Control: vaginal suppository of progestrone, 100mg, daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemie hospital
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Hamadan university of medical sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Mehrangiz Zamani
Position
assistance
Other areas of specialty/work
Street address
Hamadan university of medical sciences
City
Hamadan
Postal code
Phone
+98 918 811 2098
Fax
Email
m.zamani@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Zahara Sabokru
Position
resident
Other areas of specialty/work
Street address
Hamadan university of medical sciences
City
Hamadan
Postal code
Phone
+98 912 362 8671
Fax
Email
z.sabokro@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)