Protocol summary
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Study aim
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Comparison of Oxytocin and Uriculotherapy on labor duration in primiparous women
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Design
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Clinical trials have two groups of intervention, without blindness, randomized
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Settings and conduct
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105 women admitted to lab of selected hospitals under the supervision of Qom University of Medical Sciences were randomly divided into two groups of interventional oxytocin therapy and oxytocin group with uriculotherapy intervention. In this study blindness was not done
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Participants/Inclusion and exclusion criteria
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Entrance = prenatal, low risk pregnancy, 37-40 week, cephalic, monocular, 4 cm dilatation, age of 18-35, normal BMI, literacy, healthy ear. No entry. Healthy drinking bowl. Drug abuse, addiction, athletic behavior, Infertility, illiteracy,hearing and ear duct disease.
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Intervention groups
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In the first intervention group, oxytocin infusion was performed with glucose-benign or ringer serum; 10 units per 1000 cc serum. Injecting and diluting the drug in order to get Santo with serum drops through the veins. We start the intravenous infusion of oxytocin (Sento) with 4 drops and according to the delivery chart of the partogragor every 10 minutes After controlling the contractions and heart rate of the fetus, we can raise 4 drops.In the second intervention group, in addition to oxytocin, an ovariectrician technique was used by a researcher whose mother was in pain and had no pain, and the first time after 4 hours, which did not develop after an hour, and then at dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (Zero, Gray Man, Endocrine, Thalamic Point), Pituitary gonadotropin points, uterine regions, prostaglandin points, external genital points using the Populator Plus (2) device. The investigator for each patient with a Pointer Plus device for 30 seconds Presses the points in both ears at intervals of 1 hour.
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Main outcome variables
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Length of labor before and after intervention
General information
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Reason for update
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We added the end of time sampling and the end of clinical trial study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180415039310N2
Registration date:
2018-10-18, 1397/07/26
Registration timing:
prospective
Last update:
2020-12-17, 1399/09/27
Update count:
1
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Registration date
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2018-10-18, 1397/07/26
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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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2019-03-15, 1397/12/24
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Expected recruitment end date
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2019-09-15, 1398/06/24
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Actual recruitment start date
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2019-10-04, 1398/07/12
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Actual recruitment end date
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2020-11-05, 1399/08/15
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Trial completion date
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2020-11-21, 1399/09/01
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Scientific title
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Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women
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Public title
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Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- Primiparous women
Containing low-risk pregnancy
Gestational age 40-37 weeks
Cephalic presentation
Single pregnancy
Dilatation 4 cm or less dilatation or less zinc per hour
Age between 18-35 years
Minimize reading and writing
Have at least one healthy ears.
Have a healthy water bag
BMI>19.8،BMI<26.4
Exclusion criteria:
Receiving analgesic drugs 3 hours before the start and during of the study
Drug Addiction
Athleticism
Infertility history
Illiteracy
Underlying disease associated with auditory and auditory duct
Disorders during pregnancy
Referring to the center with a tear-off water bag and Curio Amnio Nit
Lack of satisfaction to continue participating in the study
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Age
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From 18 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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4
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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:
105
Actual sample size reached:
91
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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Clinical trial, control group, non-blind, randomized
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-18, 1397/06/27
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Ethics committee reference number
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ir.arakmu.rec.1397.130
Health conditions studied
1
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Description of health condition studied
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The duration of labor for primipara women
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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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The duration of labor in primiparous women
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Timepoint
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after intervention
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Method of measurement
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Time(second)
Secondary outcomes
1
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Description
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The duration of second phase of labor in primipara
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Timepoint
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second phase labor
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Method of measurement
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Time(second)
Intervention groups
1
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Description
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Intervention group: Intervention group: 105 women admitted to labor were randomly assigned into two groups of interventional oxytocin therapy and oxytocin group with uriculotherapy intervention.In the first intervention group, oxytocin is injected with glucose-benign or ringer serum; 10 units per 1000 cc of serum. These ampoules are stored in the refrigerator and used for induction of labor with oxytocin using an intravenous method. I attach a ringer head to the woman and take the medication in my throat to dilute it with the drops of serum through the veins. We start the intravenous infusion of Oxytocin (Sento) with 4 drops and according to Partogroup delivery chart Every 10 minutes after controlling the contractions and heart rate of the fetus, we can raise 4 drops.As long as the uterus achieves appropriate contractions, or the number of droplets reaches a maximum of 64 drops per minute. If contractions are achieved at the right rate (3 shifts per 10 minutes, each longer than 40 seconds and maximum 60 seconds), there is no need to increase the dose further and injections are maintained at the same speed.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: In the second intervention group, in addition to oxytocin, an ovariectrician technique was used by a researcher whose mother was in pain and had no pain, and the first time after 4 hours, which did not develop after an hour, and then at dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (2 points), uterine points (3 dots), prostaglandin points (2 dots), genital outer points (2 dots) using a pointer plate of Excel (2), pituitary gland (2 points) (Made in China). For every patient with a Pointer Plus device for 30 seconds, the listed points In both ears, it presses every 1 hour.
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Category
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Treatment - Other
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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Arak 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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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Publish document as article
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When the data will become available and for how long
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Between the next 12 and 18 months
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To whom data/document is available
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All people
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Under which criteria data/document could be used
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Notices
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From where data/document is obtainable
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magazines
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What processes are involved for a request to access data/document
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onlin
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Comments
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