Comparison of Oxytocin and Uriculotherapy on labor duration in primiparous women
Design
Clinical trials have two groups of intervention, without blindness, randomized
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Length of labor before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180415039310N2
Registration date:2018-10-18, 1397/07/26
Registration timing:prospective
Last update:2018-10-18, 1397/07/26
Update count:1
Registration date
2018-10-18, 1397/07/26
Registrant information
Name
Narges Sheikhghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3289 0603
Email address
n.sheikhghanbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-15, 1397/12/24
Expected recruitment end date
2019-09-15, 1398/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women
Public title
Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Clinical trial, control group, non-blind, randomized
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Dr. Mohammad Rafiee،Research Deputy،Supreme Prophet (pbuh) complex،Basij Square،Sardasht،Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
ir.arakmu.rec.1397.130
Health conditions studied
1
Description of health condition studied
The duration of labor for primipara women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of labor in primiparous women
Timepoint
Before intervention, after intervention
Method of measurement
Paratheogram of labor
Secondary outcomes
1
Description
The duration of labor in secondary primiparas
Timepoint
Before the intervention,the next step
Method of measurement
Paratheogram of labor
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected hospitals under the supervision of Qom Medical Sciences University
Full name of responsible person
Narges sheikhghanbari
Street address
Qom University of Medical Sciences،Coastal street،Qom
City
Qom
Province
Ghoum
Postal code
3716889788
Email
n.sheikhghanbari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjmandzadegan
Street address
Research Deputy،Supreme Prophet (pbuh) complex،Basij Square،Sardasht،Arak
City
اراک
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Narges sheikhghanbari
Position
Student Masters Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, Salman Town, Daniel Street
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3289 0603
Email
n.sheikhghanbari@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Ph.D. in Reproductive Health and Academic Member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
University of Medical Sciences, Faculty of Nursing and Midwifery, Sardasht, arak
City
arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
dr.kvakilian@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Narges sheikhghanbari
Position
Student Masters Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, Salman Town, Daniel Street
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3289 0603
Email
n.sheikhghanbari@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Publish document as article
When the data will become available and for how long
Between the next 12 and 18 months
To whom data/document is available
All people
Under which criteria data/document could be used
Notices
From where data/document is obtainable
magazines
What processes are involved for a request to access data/document