Evaluating the effects of outpatient administration of isosorbide mononitrate on cervical ripening.
Design
Double blind, randomized controlled clinical trial with a parallel group on 145 pregnant women with a gestational age of 39-41 weeks
Settings and conduct
The study was performed in Akbarabadi teaching hospital. Eligible women were randomly divided into two groups of intervention (isosorbide receiving) and control (placebo administration). Researcher, patients and outcome assessors, were not aware of the groups to which participants were allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women with a gestational age of 39 - 40 weeks, intact membranes, Bishop Score < 6, singleton and cephalic presentation.
Exclusion criteria: age of less than 18 years, urgent indication for pregnancy termination, antihypertensive therapy, fetal death and contraindications for treatment with Isosorbide mononitrate.
Intervention groups
Isosorbide-5-mononitrate capsules or placebo were inserted in the posterior vaginal fornix for two consecutive days (50 mg per day).
Main outcome variables
Main outcome variables: Bishop score 48 hours after intervention; Frequency of vaginal delivery; gestational age at the onset of spontaneous labor and interval between intervention to delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091023002624N27
Registration date:2018-08-24, 1397/06/02
Registration timing:retrospective
Last update:2018-08-24, 1397/06/02
Update count:0
Registration date
2018-08-24, 1397/06/02
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
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2018-02-09, 1396/11/20
Trial completion date
empty
Scientific title
Evaluation of the efficacy of isosorbide mononitrate on cervical ripening in outpatient pregnant women with unfavorable cervix.
Public title
Effects of isosorbide mononitrate on cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant
Gestational age of 39 - 41 weeks
Intact membrane
Bishop Score < 6
Singleton
Cephalic presentation
Maternal age between 18- 40 years old
Exclusion criteria:
Anti-hypertensive therapy
Fetal death
Known hypersensitivity to isosorbide mononitrate
Aortic stenosis
Obstructive myocardial hypertrophy
Systolic blood pressure< 95 mm Hg
Cardiovascular collapse
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
142
Actual sample size reached:
145
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women were randomly assigned into two groups of drug and placebo. Randomization was performed using sealed envelopes and participants were divided in four blocks; A, B, C, D. Groups A and C received drug and groups B and D received placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher, patients and outcome assessors, were not aware of the groups to which participants were allocated. The placebo was completely similar to isosorbide mononitrate in shape, taste and smell, and was made by the same manufacturer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Chamran Highway Cross.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.IUMS.REC 1395.9211290004
Health conditions studied
1
Description of health condition studied
Cervical ripening in pregnancy.
ICD-10 code
O34.4
ICD-10 code description
Maternal care for other abnormalities of cervix
2
Description of health condition studied
Prolonged pregnancy
ICD-10 code
O48.1
ICD-10 code description
Prolonged pregnancy
3
Description of health condition studied
Failed medical induction of labour
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labor
Primary outcomes
1
Description
Bishop scores 48 hours after intervention
Timepoint
48 hours after intervention
Method of measurement
Vaginal examination
Secondary outcomes
1
Description
Frequency of vaginal delivery
Timepoint
At birth
Method of measurement
Data sheets
2
Description
Gestational age at the onset of spontaneous labor
Timepoint
Onset of spontaneous labor
Method of measurement
Data sheets
3
Description
Interval between intervention to delivery
Timepoint
At delivery
Method of measurement
Data sheets
Intervention groups
1
Description
Intervention group: Two capsules of 50 mg isosorbide-5-mononitrate were inserted in the posterior vaginal fornix in two consecutive days (50 mg per day).
Category
Treatment - Drugs
2
Description
Control group: Two capsules of placebo, were inserted in the posterior vaginal fornix by the researcher in two consecutive days (50 mg per day).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi street, Molavi cross.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
SeyyedKazem Malakouti
Street address
Hemmat Highway, Chamran Cross
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Ave., Molavi Cross.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi AVE., Molavi Cross.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Ave., Molavi Cross
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available