Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Frequency of fetal meconium excretion,Average score of Apgar
General information
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Reason for update
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Modification of sampling date; sampling date was after the date of clinical trial registration.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150407021653N18
Registration date:
2019-05-25, 1398/03/04
Registration timing:
prospective
Last update:
2020-12-29, 1399/10/09
Update count:
1
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Registration date
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2019-05-25, 1398/03/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-22, 1398/04/01
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Expected recruitment end date
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2020-02-20, 1398/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Comparison of the effect of misoprostol and oxytocin on the induction of labor.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-16, 1397/10/26
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Ethics committee reference number
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IR.JUMS.REC.1397.106
Health conditions studied
1
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Description of health condition studied
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Effect of termination of pregnancy on maternal and fetal factors
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Frequency of fetal heart rate drop
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Timepoint
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End of labor after intervention
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Method of measurement
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By scoring the Apgar
2
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Description
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Average score of the Apgar
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Timepoint
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End of labor after intervention
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Method of measurement
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By scoring the Apgar
Secondary outcomes
1
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Description
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Length of latent phase of labor
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Timepoint
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From the beginning of labor pain to the end of labor
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Method of measurement
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In minutes
2
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Description
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Duration of active phase of labor
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Timepoint
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From the 5-3 cm cervical dilatation to the end of pregnancy
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Method of measurement
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In minutes
Intervention groups
1
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Description
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Control group: As the control group, the physiological delivery is considered.
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Category
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Treatment - Drugs
2
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Description
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Intervention group1: receive misoprostol at a dose of 25 micrograms، during delivery.
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Category
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Treatment - Drugs
3
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Description
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Intervention group2: receive oxytocin at a dose of 2 mlU / min، during delivery.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Jahrom University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available