The objective of this study is assessment of the effect of 17 hydroxy progesterone decaproate in prevention of preterm labour. inclusion criteria include gestational age between 24_34week and exclusion criteria include cervix dilation more than 2 cm. the population under study includes high risk pregnant women with history of preterm labour congenital abnormality or acquired abnormalities of uteri, history of preterm labour in patient, her sister or mother at gestational age of 24_34 week. that come to Besat hospital in Sanandaj. sample size is 100 patient in each of two groups. all patients were assigned randomly to placebo and tried group after written consent. between 24_34 week of gestation to one group placebo and to the other group 17 hydroxy progesterone decaproate is given. every group is being assessed for labour time. the aim of this study is assessment of preterm labour in each of two groups.
General information
Acronym
PTL
IRCT registration information
IRCT registration number:IRCT2014101019222N2
Registration date:2014-11-17, 1393/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-17, 1393/08/26
Registrant information
Name
Nazli Hamrah
Name of organization / entity
Kurdestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 5910
Email address
dr.nhamrah@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdestan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the 17 alpha hydroxy progesterone caproate in prevention of preterm labour in high risk pregnant women
Public title
Effect of the progesterone injection in prevention of preterm labour
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: single gestation; history of preterm labour before 37 week; history of preterm birth; history of preterm labour in sister;congenital or acquired uterine anomalies; age>18 and <45.
Exclusion criteria: Hypertension; cancer; epilepsy; thromboembolic disease; asthma; age<18 and >45; IUGR; vaginal bleeding; PROM; cervical dilation>2cm; fetal major anomalies; progesterone sensitivity; not to follow up the patients; twin pregnancy; tocolytic contraindications; uterine contraction; diabetes; history of cerclage; shortening of cervix.
Age
From 18 years old to 45 years old
Gender
Female
Phase
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
Vice chancellor for research Kurdestan University of Medical Sciences
Street address
Kurditan University of Medial Sciences, Pasdaran st.
City
Sanandaj
Postal code
6618634683
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
14/2688
Health conditions studied
1
Description of health condition studied
PRETERM LABOUR
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
preterm labour before of 37 weeks
Timepoint
At the onset of intervention to preterm labor or to complete 37 weeks of pregnancy
Method of measurement
Patient visits, uterine contraction determination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intramuscular dose of 250 mg 17 - alpha-hydroxyprogesterone caproate is administered once a week until the occurrence of preterm birth or complete of 34 weeks of pregnancy
Category
Treatment - Drugs
2
Description
Control group: intramuscular dose of 250 mg placebo injection is administered once a week until the occurrence of preterm birth or complete of 34 weeks of pregnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital Sanandaj
Full name of responsible person
Nazli Hamrah MD
Street address
Besat Hospital, Keshavarz ST
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdestan University of Medical Sciences
Full name of responsible person
Mr.Fardin Gharibi
Street address
Kurdestan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdestan 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
Besat Hospital
Full name of responsible person
Nazli Hamrah MD
Position
Resident of Obsterics & Gynecology
Other areas of specialty/work
Street address
Obestetric & Gynecology Department, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1328 5910
Fax
+98 87 1328 2003
Email
dr.nhamrah@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Sholeh Shahgheibi MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Obestetric &Gynecology Department, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1328 5910
Fax
+98 87 1328 2003
Email
dr.nhamrah@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Nazli Hamrah MD
Position
Resident Of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Obestetric & Gynecology Department, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
6618634683
Phone
+98 87 1328 5910
Fax
+98 87 1328 2003
Email
dr.nhamrah@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)