Comparison of the Effects of Vaginal Progesterone (Cyclogest) and Intramuscular Progesterone (Hydroxyprogesterone Caproate) in the Prevention of Preterm Labor
The purpose of this study was to evaluate and to compare the efficacy of vaginal progesterone and intramuscular progesterone in the prevention of preterm delivery. Pregnant women with a risk factor of preterm delivery were enrolled. Women with multiple pregnancy, severe liver disease and sensitivity to hormonal therapy were excluded. The study population was consisted of the pregnant women who admitted to Shahid Sadoughi hospital at gestational age of 16-20 weeks. The required calculated sample size was 76 subjects. Interventions included the prescription of vaginal progesterone or intramuscular progesterone. Interventions were started at gestational age of 16-20 weeks and were followed up till delivery. The primary outcomes were the mean delivery time and the percent of preterm delivery in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040921670N1
Registration date:2015-05-05, 1394/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-05, 1394/02/15
Registrant information
Name
Elham Bahrami
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
bahrami_hmrc@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Vaginal Progesterone (Cyclogest) and Intramuscular Progesterone (Hydroxyprogesterone Caproate) in the Prevention of Preterm Labor
Public title
the effect of progesterone in the prevention of preterm delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: History of preterm delivery; cervix length of <25 mm at gestational age of 16-20 weeks
Exclusion criteria: Multiple pregnancy; severe liver disease; hypertension; diabetes; cardiovascular disease; thromboembolic disorder; seizures; sensitivity to hormonal therapy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethical committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Bld., Yazd