The aim of present study was to compare indometacin and Mg sulfate in delaying of premature labour pain. A randomized controlled trial was carried out on 60 pregnant women who were in 24-32 gestational age and referred to Shabihekhani hospital with painful uterine contraction and pressure in pelvic. The participants were randomly assigned into 2 equal groups. The control group received magnesium sulfate %20, 4 grams IV and 2gr/hour until stopping or decreasing of uterine contraction and if uterine contraction did not decreased after 1 hour, they would treat with 3gr magnesium sulfate. The intervention group received 50mg rectal suppository of indometacin and then continued every 6 hours until 24 hours. They would receive antibiotic if labor pain developed or uterine contraction didn’t decrease or stop. Vital sign, vaginal bleeding, rupture membrane, duration of postponing of delivery, FHR, and uterine contraction were compared in 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811223329N1
Registration date:2010-09-30, 1389/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Zahra Sooki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
sooki_za@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Kashan University of Medical Sciences
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of delaying in premature labour by indomethacin and Mg sulfate in pregnant women referred to maternity hospital
Public title
Comparison of delaying in premature labour by indomethacin and Mg sulfate in pregnant women referred to maternity hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 24-32 based on LMP and sonography during first trimester, single pregnancy, intact membrane, lack of GI or kidney disease, myasthenia gravis
Exclusion criteria: rupture membrane, vaginal bleeding, dilatation ≥ 5 centimeter, placenta and fetal abnormalities, allergy to indomethacin, tocolytic therapy
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Kashan University of Medical Sciences and Health Services, Ravand street
City
Kashan
Postal code
81151-89159
Approval date
empty
Ethics committee reference number
799/1/5/29/پ
Health conditions studied
1
Description of health condition studied
premature labour pain
ICD-10 code
060.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
uterine contraction
Timepoint
every 15 minutes until 1 hour
Method of measurement
palpation of uterine contraction via abdomen
Secondary outcomes
1
Description
vaginal bleeding
Timepoint
during 48 hours
Method of measurement
self reporting
2
Description
rupture of membrane
Timepoint
during 48 hours
Method of measurement
self reporting
3
Description
duration of delivery delaying
Timepoint
during 48 hours
Method of measurement
control of contraction
4
Description
fetal heart rate
Timepoint
during 48 hours
Method of measurement
sonicade
Intervention groups
1
Description
Mg sulfate 4 gr %20, IV, during 20 minutes and then 2 gr until decreasing or stop of uterine contraction in IV infusion. If there was no decreasing in uterine contraction with 2 gr then 3 gr Mg sulfate was used.
Category
Treatment - Drugs
2
Description
Indomethacin, 50 mg, rectally, and then 50 mg every 6 hours until 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihekhani Maternity hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr hamidi
Street address
Kashan University of Medical Sciences and Health Services, Ravand road, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences and Health Services
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
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Zahra Sooky
Position
MS of midwifery/ Member of Faculty
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, Ravand street,
City
Kashan
Postal code
87159-81151
Phone
+98 36 1557 9191
Fax
Email
soki_z@kaums
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Elahe Mesdaghinia
Position
Gynecologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, Ravand street
City
Kashan
Postal code
87159-81151
Phone
+98 36 1557 9191
Fax
Email
mesdaghynia.elahe@ysahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Zahra Sooky
Position
MS of midwifery
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, Ravand street,
City
Kashan
Postal code
87159-81151
Phone
+98 36 1557 9191
Fax
+98 36 1555 6633
Email
soki_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)