A comparision of out patient oral and vaginal Isosorbide dinitrate in cervical ripening befor induction of labor in post term pregnancy with low bishop score
This randomized double-blind clinical trial compares the efficacy of outpatient vaginal and oral isosorbide dinitrate (ISDN) on cervical ripening before induction of labor. 150 nulliparous women are randomly assigned into three groups: vaginal ISDN (40 mg), oral ISDN (20 mg), control (no drug).The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day. With adequate contractions, induction to delivery time and method of pregnancy termination will be compared between groups. Statistical analysis is performed with the use of the SPSS software, version16. To compare quantitative data between the three groups with normal distribution, one way ANOVA and to compare pairs of groups (if significant) Post Hoc Tokey method is used. Chi square test is used to compare qualitative variables between the three groups. p≤0.05 considered to be significant r.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108157334N1
Registration date:2012-10-08, 1391/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Mahsa Kaveh
Name of organization / entity
tehran university
Country
Iran (Islamic Republic of)
Phone
+98 21 7759 5028
Email address
l-haghighi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
|Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparision of out patient oral and vaginal Isosorbide dinitrate in cervical ripening befor induction of labor in post term pregnancy with low bishop score
Public title
Efficacy of Isosorbide dinitrate in cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1)Nulliparity 2)Gestational age>42 weeks 3)Bishop score<5 4)Singleton pregnancy 5)Cephalic presentation 6) filled Consent form.
Exclusion criteria:
1)Premature rupture of membrane 2)Vaginal bleeding 3)Contraindication for ISDN 4)History of any uterian scar 5)Intolerance to ISDN 6)Any systemic disease 7)Laber pain 8)Oligohydramnios 9)IUGR 10)Non-reassuring FHR
Age
From 10 years old to 50 years old
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)
Double 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 Ethics Committee
Street address
Tehran University of Medical Sciences, Enghelab st.
City
Tehran
Postal code
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
2014
Health conditions studied
1
Description of health condition studied
Isosorbide dinitrate effect on cervical ripening
ICD-10 code
P08
ICD-10 code description
Disorders related to long gestation and high birth weight
Primary outcomes
1
Description
Cervical ripening
Timepoint
24 hours
Method of measurement
Vaginal exam
Secondary outcomes
1
Description
Time from full dilatation to delivery
Timepoint
Stage 2 of labor
Method of measurement
Minut
2
Description
Time from active phase to full dilation
Timepoint
Stage 1 of labor
Method of measurement
Minut
3
Description
from induction to active phase
Timepoint
active phase
Method of measurement
minut
Intervention groups
1
Description
Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate 40 mg should be placed vaginaly in posterior fornix.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 unit oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if headache is occures after administration of ISDN, patient should be given acetaminophen. .
Category
Treatment - Drugs
2
Description
Samples of investigation are divided into three groups based on randomly numbers table., in one group isosorbide dinitrate20 mg should be given oraly.The Bishop score is determined at the beginning of the study. After taking medication, the patients will be under observe for 4 hours and then discharged and advised to return 24 hours later for assessing Bishop score and induction of labor.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time MEASURE. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day Also, if the headache is detect after administration of ISDN shuld given acetaminophen. .
Category
Treatment - Drugs
3
Description
Samples of investigation are divided into three groups based on randomly numbers tablethat one group is control.they dont take any drug.The Bishop score is determined at the beginning of the study.THE induction starts with2.5mIU/min of 10 mg oxitocin in 1000 ml Ringer lactate and every fifteen minutes 2.5mIU/min will be added . With adequate contractions, induction to delivery time is measured. If adequate contractions is not induced with max 40 mIU/min oxytocin,labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day .if bishop score with adequate contractions dont change after 12 hours, labor induction is stopped and the patient returns to prenatal unit waiting for second induction in the next day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr Ladan Haghighi
Street address
Akbar abadi hospital
City
Tehran
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 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
Dr Ladan Haghighi
Position
Associated professor
Other areas of specialty/work
Street address
Enghelab street -tehran university
City
Tehran
Postal code
Phone
+98 21 66111
Fax
Email
l-haghighi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ladan Haghighi
Position
Associate professor
Other areas of specialty/work
Street address
Enghelab street -Tehran university
City
Tehran
Postal code
Phone
+98 21 66111
Fax
Email
l-haghighi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Kaveh
Position
MD
Other areas of specialty/work
Street address
Enghelab street
City
Tehran
Postal code
Phone
+98 21 7759 5028
Fax
Email
dr.mahsakaveh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)