IRCT | Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women

#	Registration date	Revision Id
2	2020-12-17, 1399/09/27	163439
1	2018-10-18, 1397/07/26	63559

Protocol summary

Study aim: 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: We added the end of time sampling and the end of clinical trial study
Acronym
IRCT registration information: 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
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: 2019-10-04, 1398/07/12
Actual recruitment end date: 2020-11-05, 1399/08/15
Trial completion date: 2020-11-21, 1399/09/01

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: 4
Groups that have been masked: No information
Sample size: Target sample size: 105

Actual sample size reached: 91
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: after intervention
Method of measurement: Time(second)

Secondary outcomes

1

Description: The duration of second phase of labor in primipara
Timepoint: second phase labor
Method of measurement: Time(second)

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

Phone

+98 86 3417 3505

Email

n.sheikhghanbari@arakmu.ac.ir

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

Arak

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: onlin
Comments

Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women

Help:

General information

Primary outcomes

#1

Secondary outcomes

#1

Recruitment centers

#1

Protocol summary

General information

Secondary Ids

Ethics committees

1

Health conditions studied

1

Primary outcomes

1

Secondary outcomes

1

Intervention groups

1

2

Recruitment centers

1

1

Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan

Comparison of Oxytocin and Uriculotherapy on the duration of labor in primipara women

Help:

General information

Primary outcomes

#1

Secondary outcomes

#1

Recruitment centers

#1

Sponsors / Funding sources

#1

Protocol summary

General information

Secondary Ids

Ethics committees

1

Health conditions studied

1

Primary outcomes

1

Secondary outcomes

1

Intervention groups

1

2

Recruitment centers

1

Sponsors / Funding sources

1

Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan