comparison of efficacy of indomethacin and magnesium sulphate in prevention of preterm labour on 28-32 weeks pregnant women referred to Alzahra maternity hospital in Tabriz
The aim of this study was to compare the effects of indomethacin and magnesium sulfate in delaying delivery and compare maternal and neonatal outcome associated with the effects of the two drugs. This study is a randomized clinical trial. The study will be carried out on 150 pregnant women with a gestational age of 32-28 with a diagnosis of preterm labor so that have at least two uterine contractions are 30 seconds in the 10 minutes and cervical dilatation of less than 6-5 cm With cervical effacement of 60% -50% Who are admitted Tabriz Alzahra hospital. The patient will be excluded if rupture of amniotic membrane, Oligohydramnious, Vaginal bleeding and dilatation more than 5 cm. Patients will be randomly assigned to two equal groups of 75 people Patients Group (A): treated with 50% of the Pasteur Institute of magnesium sulfate 4 g intravenously within 20 minutes and will continue 2 gr IV infusion until to reduce or stop uterine contractions. In group B wont be treated with indomethacin suppository made in Iran, first 50 mg and then 50 mg every 6 hours until 24 hours. This study is not blind. Time delay in delivery and maternal morbidity and neonatal complications in two groups will be discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062613777N1
Registration date:2013-10-23, 1392/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-23, 1392/08/01
Registrant information
Name
Shamsi Abbasalizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
abbasalizadehs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-06, 1392/05/15
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy of indomethacin and magnesium sulphate in prevention of preterm labour on 28-32 weeks pregnant women referred to Alzahra maternity hospital in Tabriz
Public title
comparison of efficacy of indomethacin and magnesium sulphate in prevention of preterm labour
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria:
1- Pregnant women with gestational age of 32-28 weeks
1. Patients who have at least two or more than two contractions lasting 30 seconds during 10 minutes
2. Progress of dilation less than 5-6 cm
3.Effacement of cervix under 50-60% and also be ripe
Excluding criteria:
1.Preterm Rupture of amniotic membranes
2.Oligohydramnious
3.Vaginal bleeding
4.nonassuring pattern of fetal heart
5. Allergic responses to indomethacin
6.Renal failure or Gastrointestinal
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht avenue
City
Tabriz
Postal code
5138665793
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
12325/4/5
Health conditions studied
1
Description of health condition studied
preterm Labour
ICD-10 code
O60.0
ICD-10 code description
Onset (spontaneous) of labour before 37 completed weeks of gestation
Primary outcomes
1
Description
Preterm birth
Timepoint
After intervening to fix premature contractions.
Method of measurement
Visual pain scale
Secondary outcomes
1
Description
Neonatal morbidity
Timepoint
After intervening until discharge neonatal from the NICU
Method of measurement
Check list
Intervention groups
1
Description
Intervention 1: magnesium sulfate (50%) of 4 mg IV over 20 min, and then 2 mg intravenous infusion every hours until the reduction or cessation of uterine contractions continue.
Category
Treatment - Drugs
2
Description
Case 2: Initially, 50 mg indomethacin , and then 50 mg every 6 hours for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr.Shamsi Abbasalizadeh
Street address
Alzahra hospital,South Artesh
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Shamsi Abbasalizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
abbasalizadehs@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Shamsi Abbasalizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
abbasalizadehs@tbzmed.ac.ir; wrhrcenter@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Shamsi Abbasalizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
abbasalizadehs@tbzmed.ac.ir; wrhrcenter@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)