Comparison of the effect of misoprostol and oxytocin for the induction of labor in order to terminate pregnancy on maternal and fetal factors in pregnant women.
Comparison of the effect of misoprostol with oxytocin for labor Stimulations with physiological delivery control group, for termination of pregnancy on maternal and fetal factors.
Design
This randomized study with Parallel groups will be conducted on 90 primiparous pregnant women. Patients will randomly be divided into 3 groups by intra-envelope numbers. First intervention group: As the control group for performing physiological delivery Are considered. Second intervention group: receive misoprostol at a dose of 25 micrograms during delivery. Third intervention group receive oxytocin at a dose of 2 mlU / min during delivery.
Settings and conduct
This randomized study will be conducted in pregnant women referred to the Motahari Hospital of Jahrom. Patients who have criteria for entering the study by intra-envelope numbers will be divided into three groups And Average score of Apgar in the three groups will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant pregnant women ages 20-35 years، Women with a pregnancy term> 37 weeks، Lack of contraindication for normal delivery، Lack of drug sensitivity to Misoprostol and oxytocin.
exclusion criteria: Limit of fetal growth،Suspected of fetal abnormality.
Intervention groups
First intervention group: As the control group, the physiological delivery is considered.
Second intervention group: receive misoprostol at a dose of 25 micrograms during delivery.
Third intervention group: receive oxytocin at a dose of 2 mlU / min during delivery.
Main outcome variables
Frequency of fetal meconium excretion,Average score of Apgar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150407021653N18
Registration date:2019-05-25, 1398/03/04
Registration timing:registered_while_recruiting
Last update:2019-05-25, 1398/03/04
Update count:1
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-10-28, 1398/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of misoprostol and oxytocin for the induction of labor in order to terminate pregnancy on maternal and fetal factors in pregnant women.
Public title
Comparison of the effect of misoprostol and oxytocin on the induction of labor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 20-35
Women with a term of pregnancy> 37 weeks
Lack of Contraindication for normal delivery
Lack of drug sensitivity to misoprostol and oxytocin
Lack of chronic diseases
Exclusion criteria:
Dissatisfaction of participants to attend the study
Tearing membranes
Limit of fetal growth
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method will be performed by a sealed envelope, in which the number of the groups will be placed, and Participants in the study will be randomly divided into three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Jahrom, Motahari Blvd. Pardis building
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.JUMS.REC.1397.106
Health conditions studied
1
Description of health condition studied
Effect of termination of pregnancy on maternal and fetal factors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Frequency of fetal heart rate drop
Timepoint
End of labor after intervention
Method of measurement
By scoring the Apgar
2
Description
Average score of the Apgar
Timepoint
End of labor after intervention
Method of measurement
By scoring the Apgar
Secondary outcomes
1
Description
Length of latent phase of labor
Timepoint
From the beginning of labor pain to the end of labor
Method of measurement
In minutes
2
Description
Duration of active phase of labor
Timepoint
From the 5-3 cm cervical dilatation to the end of pregnancy
Method of measurement
In minutes
Intervention groups
1
Description
Control group: As the control group, the physiological delivery is considered.
Category
Treatment - Drugs
2
Description
Intervention group1: receive misoprostol at a dose of 25 micrograms، during delivery.
Category
Treatment - Drugs
3
Description
Intervention group2: receive oxytocin at a dose of 2 mlU / min، during delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari hospital
Full name of responsible person
Athar Rasekh Jahromi
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasek@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasek@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasek@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasek@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Zahra Sonbole
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
rostamiz1010@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD