Objectives: This research aims to investigate the effect of 17 alpha-hydroxyprogesterone caproate on the prevention of preterm labor after inhibiting uterine contractions in Shariati hospital of Bandar Abbas.
Design: The research population consists of all women with single pregnancy who visited Shariati hospital due to premature uterine contractions within 26-34 weeks of pregnancy. 100 subjects belonged to the treatment group and 100 others were in the control. This research is of a randomized clinical trial type. It is also a single-blind prospective and mono-centered study conducted in a simple randomized method.
Setting and conduct: there are two groups involved, a control group and a treatment which tests the effect of 17 alpha-hydroxyprogesterone caproate.
Interventions: patients were given 2 doses of 12 mg of betamethasone within 24 hours (with an interval of 12 hours) for fetal lung maturation. Within 48hours of the stopping of uterine contractions, the patients were randomly assigned to either the treatment or the control group. The former received an intramuscular injection of 17 alpha-hydroxyprogesterone (500 mg) once a week. The latter group received no such injection.
Inclusion criteria: pregnancy age between 26-34 weeks, presence of premature uterine contractions. Exclusion criteria: pregnancy age ≥34 weeks, premature rupture of membranes, Chorioretiniti, pre-labor blood loss as in placental abruption.
main outcome measures:
Primary variable: determining the prevention of preterm labor after inhibiting uterine contractions under the effect of 17 alpha-hydroxyprogesterone.
Secondary variable: none
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050119396N3
Registration date:2016-01-31, 1394/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Razieh Rrajabzadeh
Name of organization / entity
Hormozgan University of Medical Scienes
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7104
Email address
barvari@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Hormozgan University of Medical Sciences
Expected recruitment start date
2014-07-30, 1393/05/08
Expected recruitment end date
2014-12-04, 1393/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Estimating the therapeutic effect of 17 alpha-hydroxy progesterone caproate in preventing preterm labor after inhibiting uterine contractions
Public title
Estimating the therapeutic effect of 17 alpha-hydroxy progesterone caproate in preventing preterm labor after inhibiting uterine contractions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Between 26-34 weeks pregnancy age; There premature uterine contractions.
Exclusion criteria: the pregnancy age above 34 weeks (since in this group there would be no reason for preventing uterine contractions due to the fetal lung maturation); preterm rupture of membranes; corioamnionite, blood loss prior to the labor due to placental abruption or previa;multiple pregnancies; concomitant systemic diseases (preeclampsia, gestational diabetes (GDM); cardiovascular diseases; kidney diseases; asthma; hyperthyroid; …).
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study will be randomly sampling.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
vice chancellor for research and technology, Shahid Mohamadi Hospital
City
Bandar Abbas
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
92-4-31-2
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60.1
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
The prevention of preterm birth after inhibition of uterine contractions.
Timepoint
48 hours after the intervention.
Method of measurement
Check up and examination
Secondary outcomes
empty
Intervention groups
1
Description
The treatment group received a weekly intramuscular injection of 17 alpha-hydroxyl progesterone (500 mg). They were advised to continue it until their 36th week of pregnancy at home. Within 48 hours of hospitalization (prior to their discharge) the patient was once again examined by the researcher. This drug made by pharmaceutical company bayer of schering pharma.
Category
Treatment - Drugs
2
Description
The control group would receive no such injection. Within 48 hours of hospitalization (prior to their discharge) the patient was once again examined by the researcher.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Dr. Ali Shariati
Full name of responsible person
azin alavi
Street address
Hospital Dr. Ali Shariati
City
St. martyr Naser-bandar abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Azim Nejatizadeh
Street address
Vice Chancellor for research of Hormozgan University of Medical Sciences
City
Bandar Abbas
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Shariati Hospital
Full name of responsible person
Azin Alavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shariati Hospital, St. shahid Nasr- Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 76 3333 2424
Fax
Email
azin_alavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati hospital, Hormozgan University of Medical Sciences
Full name of responsible person
Azin Alavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shariati hospital, Hormozgan University of Medical Sciences
City
Bandar Abbas
Postal code
Phone
+98 76 3333 2424
Fax
Email
azin_alavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati hospital, Hormozgan University of Medical Sciences
Full name of responsible person
Razieh Rajabzadeh
Position
MD, Resident of Obstetrics and Gynecology.
Other areas of specialty/work
Street address
Shariati Hospital, St. shahid Naser- Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 76 3333 7104
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)