17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix in ARASH hospital during 2012-2013 years
Objectives: To evaluate the effect of 17-alpha-hydroxyprogesterone caproate in comparison with vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix.
Design: Randomized controlled trail.
Setting and conduct: Asymptomatic pregnant women between 16-24 weeks gestation with cervix shorter than 25 mm are being studied.
Inclusion criteria: singleton pregnancy; gestational age between 16-24 weeks.
Exclusion criteria: multiple pregnancy; vaginal bleeding; confirmed or suspected chorioamnionit; having cervical cerclage; fetal abnormalities; congenital uterine abnormalities such as unicorn uterine; cevical congenital malformations such as hypoplasia of the cervix; history of cervical surgery such as conization; LEEP(loop electrical excision procedure); History of thromboembolic events; underlying disease such as uncontrolled hypertension; uncontrolled diabetes; thromboembolic disorders; heart disease and neurological – muscular disease.
Intervention: Patients were randomly divided into two groups. In one group intramuscular dose of 250 mg 17 - alpha-hydroxyprogesterone caproate is administered once a week until the occurrence of preterm birth or complete of 36 weeks of pregnancy and in another group daily 400 mg progesterone vaginal suppository continues up to 36 weeks or until the occurrence of preterm birth.
Main outcome: Preterm labor before 28 weeks of gestation, preterm labor between 28-34 gestational weeks and preterm labor between 34-37 gestational weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082610664N1
Registration date:2012-11-06, 1391/08/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Reihaneh Pirjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3288
Email address
pirjani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix in ARASH hospital during 2012-2013 years
Public title
17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix
Purpose
Prevention
Inclusion/Exclusion criteria
The study population consists of singleton pregnant women with gestational age of 16-24 weeks referring to ARASH hospital prenatal clinic for routine prenatal care. Exclusion criteria included multiple pregnancy; vaginal bleeding; confirmed or suspected chorioamnionit; having cervical cerclage; fetal abnormalities; congenital uterine abnormalities such as unicorn uterine; cevical congenital malformations such as hypoplasia of the cervix; history of cervical surgery such as conization; LEEP(loop electrical excision procedure); History of thromboembolic events; underlying disease such as uncontrolled hypertension; uncontrolled diabetes; thromboembolic disorders; heart disease and neurological – muscular disease.
Age
From 14 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
304
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
Ethics committeeTehran University of Medical Sciences
Street address
Fifth Floor, Tehran University Center Building, Qods Street, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2012-09-29, 1391/07/08
Ethics committee reference number
65961
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery Preterm labour with delivery NOS Preterm spontaneous labour with preterm delivery by caesarean section
Primary outcomes
1
Description
Preterm labour
Timepoint
At the onset of intervention to preterm labor or to complete 37 weeks of pregnancy
Method of measurement
Gestational age at delivery occurred by weeks of age
Secondary outcomes
1
Description
neonatal hospitalization rates in NICU
Timepoint
from the birth day until one month
Method of measurement
Review neonatal file
2
Description
duration of hospitalization in NICU
Timepoint
from hospitalization until discharge
Method of measurement
Review neonatal file
3
Description
neonatal birth weight
Timepoint
after birth
Method of measurement
using neonatal scales
Intervention groups
1
Description
intramuscular dose of 250 mg 17 - alpha-hydroxyprogesterone caproate is administered once a week until the occurrence of preterm birth or complete of 36 weeks of pregnancy
Category
Treatment - Drugs
2
Description
daily 400 mg progesterone vaginal suppository continues up to 36 weeks or until the occurrence of preterm birth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, ARASH Hospital
Full name of responsible person
Reihaneh Pirjani MD.
Street address
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences Vice chancellor for research
Full name of responsible person
Akbar Fotoohi Dr.
Street address
Sixth Floor, Tehran University Center Building, Qods Street, Keshavarz Boulevard, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences Vice chancellor for research
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
Tehran University of Medical Sciences
Full name of responsible person
Reihaneh Pirjani MD.
Position
Perinatologist, Assistant Professor
Other areas of specialty/work
Street address
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, ARASH Hospital
Full name of responsible person
Reihaneh Pirjani MD.
Position
Perinatologist, Assistant Professor
Other areas of specialty/work
Street address
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, ARASH Hospital
Full name of responsible person
Reihaneh Pirjani MD.
Position
Perinatologist, Assistant Professor
Other areas of specialty/work
Street address
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
City
Tehran
Postal code
Phone
+98 21 7788 3288
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)