Effect of oral progesterone versus placebo on reducing preterm labor in women with a history of preterm labor: a double blind randomized clinical trial
Objectives: To assess the effect of oral progesterone versus placebo on reducing preterm labor in women with a history of preterm labor.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible women with a history of preterm labor who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 25 years; gestational age of 18 to 24 weeks; at least a history of one preterm labor between 20 to 36 weeks.
Exclusion criteria: Bleeding in the first trimester; abnormal fetus; active liver disease.
Intervention group: Oral capsule medroxyprogesterone 100 mg twice a day until 36 weeks of pregnancy.
Control group: Oral capsule placebo twice a day until 36 weeks of pregnancy.
Primary outcome: Occurrence of preterm labor before 36 weeks of pregnancy by taking history.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710079014N192
Registration date:2017-10-09, 1396/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral progesterone versus placebo on reducing preterm labor in women with a history of preterm labor: a double blind randomized clinical trial
Public title
Effect of oral progesterone versus placebo on reducing preterm labor in women with a history of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 25 years; gestational age of 18 to 24 weeks; at least a history of one preterm labor between 20 to 36 weeks.
Exclusion criteria: Bleeding in the first trimester; abnormal fetus; active liver disease.
Age
From 18 years old to 25 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
214
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.UMSHA.REC.1395.377
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery
Primary outcomes
1
Description
Occurrence of preterm
Timepoint
Before 36 weeks of pregnancy
Method of measurement
By taking history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral capsule medroxyprogesterone 100 mg twice a day until 36 weeks of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: Oral capsule placebo twice a day until 36 weeks of pregnancy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Maryam Jamali
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, 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
Fatemieh Hospital
Full name of responsible person
Dr Maryam Jamali
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
m.jamali59@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Sohreh Alimohammadi
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
Dr_alimohamadi@.yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)