The aim of present study is to investigation about the "effectiveness of Glyceryl tri nitrate (GTN) patches on preterm labor". This is randomized, single blind, placebo controlled and clinical trial study. Eighty four15_45 years old pregnant women with preterm labor and gestational age between25 and 37 weeks will be randomized to GTN or placebo group.
Inclusion criteria: singleton pregnancy with regular uterine contraction.
Exclusion criteria: maternal or fetal indication for termination of pregnancy; multiple gestation; premature rupture of membrane(PROM); fetal anomaly; cervical dilatation equal or more than5 cm; sensitivity to nitrates or nitrates contraindication; chorioamnionitis; maternal heart disease; Vasa previa; Placenta previa.
After admission and randomization vital signs (maternal blood pressure and maternal heart rate) will be measured. FHR (fetal heart rate) will be monitored for 20 min. Patients will be hydrated with1 liter normal saline, 12 mg Betamethasone will be injected (IM). Then GTN patch or placebo patch will be applied. 1 hour later FHR monitoring, BP and MHR will be assessed. cervical examination will be done, then second patch will be applied. 24 h after randomization the second dose of Betamethasone will be administered and two patches will be removed if uterine contraction continue or cervical dilation progress then two additional patches or placebo will be applied. Finally variables including(no delivery within 24 &48 hour after randomization, number of doses of Betamethasone, complication of drugs and changes of FHR, MHR, MBP before and after patch administration) will be detected and compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108054025N3
Registration date:2011-10-26, 1390/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-26, 1390/08/04
Registrant information
Name
Anisodowleh Nankali
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
anankali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Kermanshah University of Medical Sciences.
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of transdermal nitroglycerine effect on preterm labor.
Public title
Investigation of transdermal nitroglycerine effect on preterm labor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 15 _45 years singleton pregnant women; GA 27_ 35 weeks with painful uterine contractions; equal or more than 4 contractions per 20 min or bishop score equal or more than 3.
Exclusion criteria: maternal or fetal indication for termination of pregnancy; multiple gestation; premature rupture of membrane; fetal anomaly; cervical dilatation equal or more than 5 cm; sensitivity to nitrates or nitrates contraindications; chorioamnionitis (maternal fever ,leukocytosis, fetal tachycardia); maternal heart disease; Vasa previa; Placenta previa; vaginal bleeding except bloody show.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
it is done or it is not done (patient complaint: headache, vertigo, nausea, vomiting or measured by investigator: skin redness, hypo tension)
6
Description
Change in cervical dilatation.
Timepoint
At randomization and 1 h, 24 h& 48 h later
Method of measurement
cm
Intervention groups
1
Description
Intervention group; 42 pregnant women with diagnosis of preterm labor will be treated by10 mg nitroglycerine patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked, if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed.
Category
Treatment - Drugs
2
Description
Control group; 42 pregnant women with diagnosis of preterm labor will be treated by placebo patch that will be applied on abdomen. 1 hour later vaginal exam will be done and uterine contractions will be assessed then another patch will be added .24 hour later two patches will be removed, vaginal exam will be done and uterine contractions will be assessed and patch site redness will be checked if uterine contractions continues or cervical dilation progress then two another patches will be applied. These2 patches also will be removed after48 hours after randomization. If complication such as severe headache or hypo tension will be occurs at any time, patches will be removed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity research center and Obstetrics & Gynecology Department, Imam Reza Hospital
Full name of responsible person
Parnian Kord Jamshidi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kermanshah University of Medical Sciences.
Full name of responsible person
Farid Najafi
Street address
Building No. 2, Shahid Beheshti blvd.
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences.
Full name of responsible person
Parnian Kord Jamshidi
Position
Resident
Other areas of specialty/work
Street address
Parastar blvd., Sorkheh lyjeh, Kermanshah University of Medical Sciences, Obstetrics & Gynecology Department, Imam Reza Hospital,