Normal saline was infused for all women during 30 minutes, and betamethasone was prescribed 12 mg IM, 24 hours apart for 2 doses. The women were randomely divided to 2 groups. 2 groups of women were adjusted according to age.In one group nifedipin and the other group TNG patch( which is a nitric oxide donor and each skin patch contain 10 mg TNG) were used. Blood pressure were monitored every 15 minutes for 1 hour then every 4 houres.First Nitroglycerin patch was removed after 24 houres and the second patch was used for 24 hours.
nifedipin ( IS A CALCIUM channel blocking agent and each capsule is 10 mg) group: At first, 4 capsules of Nifedipin were prescribed every 20 minutes.Then, for the first 24 hours2 capsules were prescribed every 6 hours, and for the second 24 hours 2 capsules every 8 hours and for the third 24 hours 1 capsul every 6 hours and for the fourth day 1 capsule every 8 hours were prescribed. Response to treatment was defined as arrest of contractions .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108262624N8
Registration date:2012-06-05, 1391/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran Univercity of Medical Sciences
Expected recruitment start date
2011-04-03, 1390/01/14
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between nitroglycerin skin patch and nifedipin for the treatment of preterm labbor
Public title
Treatment of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
All women who had 4 uterine contractions in 20 minutes or cervical dilatation = 1 cm and effacement = 80% with a gestational age of 26 to 36 weeks were entered the study. Exclusion criteria were: PROM; any maternal or fetal indications for pregnancy termination; IUFD; dilatation of more than 5 cm; allergy to TNG and tocolytic use during previous 24 hours.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences
Street address
Akbarabadi Hospital, Molavi Street, Molavi cross.
City
Tehran
Postal code
Approval date
2012-04-24, 1391/02/05
Ethics committee reference number
130/2704/د/90
Health conditions studied
1
Description of health condition studied
Preterm labor
ICD-10 code
060-075
ICD-10 code description
Onset (spontaneous) of labour before 37 completed weeks of gestation
Primary outcomes
1
Description
preterm labor
Timepoint
48 hours and 7 days
Method of measurement
delivery
Secondary outcomes
1
Description
adverse effects of drugs
Timepoint
every 15 minutes for 1 hour then every 4 hours
Method of measurement
blood pressure measurement
Intervention groups
1
Description
Nifedipin prescription
Category
Treatment - Drugs
2
Description
TNG skin patch prescription
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Maryam Kashanian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
Ghods avenue, Keshavarz cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Obstetrics & Gynecology, professor
Other areas of specialty/work
Street address
Akbarabadi Hospital Molavi street, Molavi cross
City
Tehran
Postal code
Phone
+98 21 7752 3487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Obstetrics & Gynecology
Other areas of specialty/work
Street address
Akbarabadi Hospital, Molavi street, Molavi cross
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
professor of , Department of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Akbarabadi Hospital, Molavi street, Molavi cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)