In this randomized double-blind clinical trial, 164 singleton pregnant women with intact amniotic membranes, between 24-34 weeks gestational age, are enrolled with a diagnosis of preterm labor. they are assigned in two groups by colored cards. Magnesium sulfate is prescribed the first group at a dose of 4 grams and followed by two grams per hour intravenously for 24 hours, at the same time a 100-miligrams celecxib capsule is administered orally. In the second group magnesium sulfate with the same dose is given and placebo is prescribed instead of celecxib. Patients and the doctor who controls them are not aware of the kind of the consumed drug. Uterine contractions in both groups are recorded by tocometer every one hour. The first time that the uterine contraction decreases is considered as onset of drug action. If the uterine contractions do not remove after 8 hours, administering of celecxib or placebo continues every 8 hours for 24 hours. And if this way also do not prevent the uterine contraction after 24 hours, the case is recorded as treatment failure and treatment is stopped.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015042621947N1
Registration date:2016-05-18, 1395/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Shahin Nemati
Name of organization / entity
Kosar Hospital
Country
Iran (Islamic Republic of)
Phone
+98 28 3223 6374
Email address
sh.nemati@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Science
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of magnesium sulfate alone and magnesium sulfate with celecxib to prevent spontaneous preterm labor in pregnant women
Public title
Effect of Celecxib in order to prevent spontaneous preterm labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Singleton pregnancy; Intact amniotic membrane; Gestational age between 24-34 weeks; Positive tocometry. Exclusion criteria: PROM; Vaginal bleeding; Chorioamnionitis; Dilatation more than 2 cm and cervical effacement exceeding 80%; Polyhydramnios; Oligohydramnios; Intrauterine Fetal Demise; Intrauterine Growth Restriction; Fetal distress; Smoking and alcohol abuse; systemic disease; Congenital anomalies; uterine anomalies; Celecxib intolerance.
Age
From 18 years old to 46 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
82 yellow cards and 82 green cards have put in the box, for each patient with study including criteria, have exit one card randomly: green card for first group (magnesium sulfate alone) and yellow card for second group (magnesium sulfate with celecxib).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
4321102589
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
28/20/8859
Health conditions studied
1
Description of health condition studied
Preterm Labor
ICD-10 code
O60.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery
Primary outcomes
1
Description
Preterm Labor
Timepoint
One hour after the onset of drug use until 24 hours
Method of measurement
Tocometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: initial dose 4 g of magnesium sulfate intravenously and then continuation of magnesium sulfate administration at a dose of 2g per hour for 24 hours with a 100 mg celecxib capsule and if needed its continuation every 8 hours for 24 hours
Category
Prevention
2
Description
Control group: initial dose 4g of magnesium sulfate intravenously and then continuation of magnesium sulfate administration at a dose of 2g per hour for 24 hours with a placebo capsule and if needed its continuation every 8 hours for 24 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Shahin Nemati
Street address
Kosar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Shahin Nemati
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farideh Movahed
Position
Obstetrics & Gynecologist
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
1317634156
Phone
+98 28 3223 6374
Fax
+98 28 3324 2661
Email
fmovahed@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Lalooha
Position
Obstetrics & Gynecologist
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
1317634156
Phone
+98 28 3223 6374
Fax
+98 28 3324 2661
Email
lalooha44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Shahin Nemati
Position
Obstetrics & Gynecologist
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
1317634156
Phone
+98 28 3223 6374
Fax
+98 28 3324 2661
Email
sh.nemati@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)