Comparison of the efficacy of oral misoprostol and intravenous oxytocin in inducing labor in rupture Premature embryonic membranes
Design
The study will be a clinical trial involving 160 pregnant mothers who have ruptured premature embryos membran between 34 and 42 weeks of gestation and will be referred to Mahdieh Hospital. After definitive diagnosis of splenic rupture in speculum or positive fren test, patients are randomly divided into two groups for induction of labor. The case group will be given 50 micrograms of misoprostol orally every 4 hours up to a maximum of 5 doses.
In the control group, oral placebo and intravenous oxytocin in ringer serum will be administered at a dose of 2mlu / min and will be performed every 2 minutes up to 40mlu / min.
Settings and conduct
The study will be a clinical trial involving 160 pregnant mothers who have ruptured premature embryos membran between 34 and 42 weeks of gestation and will be referred to Mahdieh Hospital. After definitive diagnosis of splenic rupture in speculum or positive fren test, patients are randomly divided into two groups for induction of labor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Positive Fren test
Gestational age between 34 and 42 weeks
Single pregnancy
Cephalic presentation
Intervention groups
Pregnant mothers who have ruptured premature embryos membran between 34 and 42 weeks of gestation, After definitive diagnosis of splenic rupture in speculum or positive fren test, patients are randomly divided into two groups for induction of labor. The case group will be given of misoprostol orally .
In the control group, will be given oral placebo and intravenous oxytocin.
Main outcome variables
Induction of labor with misoprostol, induction of oxytocin, first and fifth minute apgar, postpartum hemorrhage, complications of misoprostol
General information
Reason for update
Acronym
مقایسه اثر میزوپرستول خوراکی و اکسی توسین وریدی در القا زایمان
IRCT registration information
IRCT registration number:IRCT20191014045106N1
Registration date:2020-02-19, 1398/11/30
Registration timing:registered_while_recruiting
Last update:2020-02-19, 1398/11/30
Update count:0
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
maryam mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7748 3253
Email address
dr.maryam671@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes
Public title
Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of rupture of the sachet on examination with speculum or positive frenne test
Gestational age between 34 and 42 weeks
Cephalic presentation
Bishop score ≤5
Indication of vaginal termination of pregnancy
Parity less than five
Absence of active labor
Absence of active labor
Exclusion criteria:
The presence of any fetal heart rate abnormalities
A history of cesarean section or uterine scarring
Contraindications for vaginal delivery such as placenta peria
Known allergy to prostaglandin (skin manifestations, hives, rash, shortness of breath, cough, chest pain and blurred vision after previous prostaglandin use)
Estimated baby weight over 4 kg
Active labor means at least 3 contractions with sufficient force and duration of at least 40 seconds within 10 minutes.
Active cardiovascular disease, asthma, glaucoma
Vaginal bleeding
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a clinical trial involving 160 pregnant mothers, ranging from 34 to 42 week Pregnancy is referred to premature rupture of the embryo and go to Mahdieh Hospital Will do, it will be done. cervical examination and Bishop score and description It will be done. After definitive diagnosis of splenic rupture in speculum or positive fren test, patients are randomly divided into two groups for induction of labor.
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran.7th Floor, Bldg No.2 .
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.SBMU.MSP.REC.1398.533
Health conditions studied
1
Description of health condition studied
Labor in premature rupture of fetal protective membranes
ICD-10 code
Z00.12
ICD-10 code description
Encounter for routine child health examination
Primary outcomes
1
Description
Age
Timepoint
Baseline
Method of measurement
questionnaire
2
Description
Pregnancy age
Timepoint
Baseline
Method of measurement
questionnaire
3
Description
Delivery time
Timepoint
During delivery
Method of measurement
questionnaire
4
Description
First and fifth minute apgar
Timepoint
First and fifth minute
Method of measurement
Based on Apgar score determination by examiner
5
Description
Postpartum hemorrhage
Timepoint
Immediately after delivery
Method of measurement
View by examiner / Yes, No
6
Description
Excretion of neonatal meconium
Timepoint
After birth
Method of measurement
View by examiner / Yes, No
Secondary outcomes
1
Description
Side Effects Of Misoprostol
Timepoint
Postpartum
Method of measurement
Question about person / fever, nausea, Vomiting, diarrhea
Intervention groups
1
Description
Intervention group:The case group will be given 50 micrograms of misoprostol orally every 4 hours up to a maximum of 5 doses.
Category
Treatment - Drugs
2
Description
Control group:In the control group, oral placebo and intravenous oxytocin in ringer serum will be started at a dose of 2mlu / min and will be performed every 2 minutes up to 40mlu / min.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Maryam Mohammadi
Street address
Boroujerdi Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 5506 2644
Email
dr.maryam671@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ashin Zarghi
Street address
Mahdieh Hospital, Boroujerdi Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 5506 2644
Email
dr.maryam671@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Boroujerdi Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 5506 2644
Email
dr.maryam671@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Boroujerdi Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 5506 2644
Email
dr.maryam671@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Boroujerdi Street
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 912 404 1719
Email
dr.maryam671@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor in Premature Rupture of Membranes,
All of its results can be used to manage diseases.
When the data will become available and for how long
Access 5 months after the results are published
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
Management and Medical Care
From where data/document is obtainable
Mahdieh Hospital or Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
In a Written Letter to the Documentation Authorities of Mahdie Hospital of Shahid Beheshti Medical University