Effect of vaginal nitroglycerin versus receiving nothing on cervical dilation in women with post-term pregnancy: a single-blind randomized clinical trial
To assess the effect of vaginal nitroglycerin versus receiving nothing on cervical dilation in women with post-term pregnancy
Design
This is a single-blind randomized clinical trial, phase II, in which 90 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible women with post-term pregnancy who will refer to Fatemieh Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Women with post-term pregnancy (gestational age above 40 weeks and 4 days)
Nulliparous
Singleton
Cephalic presentation
Exclusion criteria:
Contraindication of nitroglycerine
Previous cesarean section or any uterine scar
Any chronic disease
Vaginal bleeding or drainage
Oligohydramnios
Intrauterine growth restriction (IUGR)
Intervention groups
Intervention group:
Prenatal routine cares plus vaginal nitroglycerin 40 mcg every 4 hours until three dose
Control group:
Just prenatal routine cares
Main outcome variables
Primary outcome:
Assessing the duration of time from induction to the active phase of labor
Assessing the amount of bleeding
Measuring the neonatal pulse rate
Measuring the maternal pulse rate
Secondary outcome:
Assessing headache and nausea
Flushing and changes in blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N282
Registration date:2019-05-29, 1398/03/08
Registration timing:prospective
Last update:2019-05-29, 1398/03/08
Update count:0
Registration date
2019-05-29, 1398/03/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal nitroglycerin versus receiving nothing on cervical dilation in women with post-term pregnancy: a single-blind randomized clinical trial
Public title
Effect of vaginal nitroglycerin versus receiving nothing on cervical dilation in women with post-term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Women with post-term pregnancy (gestational age above 40 weeks and 4 days)
Nulliparous
Singleton
Cephalic presentation
Exclusion criteria:
Contraindication of nitroglycerine
Previous cesarean section or any uterine scar
Any chronic disease
Vaginal bleeding or drainage
Oligohydramnios
Intrauterine growth restriction (IUGR)
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.UMSHA.REC.1398.089
Health conditions studied
1
Description of health condition studied
Post-term pregnancy
ICD-10 code
O48.0
ICD-10 code description
Post-term pregnancy
Primary outcomes
1
Description
Assessing the duration of time from induction to active phase of labor
Timepoint
12 hours after the intervention
Method of measurement
With physical examination
2
Description
Assessing the amount of bleeding
Timepoint
12 hours after the intervention
Method of measurement
With physical examination
3
Description
Measuring the neonatal pulse rate
Timepoint
12 hours after the intervention
Method of measurement
With physical examination
4
Description
Measuring the maternal pulse rate
Timepoint
12 hours after the intervention
Method of measurement
With physical examination
Secondary outcomes
1
Description
Assessing headache and nausea
Timepoint
12 hours after the intervention
Method of measurement
By history taking
2
Description
Flushing and changes in blood pressure
Timepoint
12 hours after the intervention
Method of measurement
Wth physical examination
Intervention groups
1
Description
Intervention group: Prenatal routine cares plus vaginal nitroglycerin 40 mcg every 4 hours until three dose
Category
Treatment - Drugs
2
Description
Just prenatal routine cares
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan City
Full name of responsible person
Mahboobeh Goodini
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mahboobeh.goodini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mahboobeh Goodini
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mahboobeh.goodini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Ahmadi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
ahmadi_1011@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Professor of Epidemiology
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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