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A comparative Study of Acupressure and Knee-Chest position in correction of Breach presentation in pregnant women:clinical trial

Protocol summary

Study aim
Comparison of the effect of knee-chest position and acupressure in correction of breech presentation and determining the effect of demographic variables (age, education, height, weight, number of pregnancies, number of deliveries, number of abortions, exercise, economic status, job status and sex of the fetus) on knee-Chest position or acupressure on the correction of breech presentation
Design
Samples will be assigned to the study groups randomly with the help of six blocks. Randomization will be done secretly; This means that 120 envelopes are prepared in a package and each code A, B and C is placed. After explaining the purpose of the study and obtaining the informed consent of the client, one of the desired envelopes will be removed in the specified order and action will be taken based on the group registered in the envelope.
Settings and conduct
health centers affiliated to Shahroud University of Medical Sciences and the office for obstetricians and gynecologists in the city.
Participants/Inclusion and exclusion criteria
Primi gravida mothers or pregnant women with a history of normal vaginal delivery who have a breech sonography at the age of 32 to 35 weeks.
Intervention groups
The acupressure group, for 14 days between 32 and 35 weeks of pregnancy, BL67 will be performed daily for 20 minutes (10 minutes of pressure on each leg). each period will include 10 seconds of pressure and 2 seconds of rest. In the group of knee-chest position for 14 days between weeks 32 to 35, 3 times a day (morning, Noon and night before bed) and each time for 10 to 15 minutes in the knee-chest position. People in the control group will only receive routine pregnancy care at 32 to 35 weeks. After 14 days from the beginning of the intervention, a person is asked to return to the research environment to perform an sonography to determine the persentation.
Main outcome variables
Change the breech persentation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130120012198N6
Registration date: 2021-03-16, 1399/12/26
Registration timing: registered_while_recruiting

Last update: 2021-03-16, 1399/12/26
Update count: 0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Mahdieh Kiani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3327 3594
Email address
kiani_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative Study of Acupressure and Knee-Chest position in correction of Breach presentation in pregnant women:clinical trial
Public title
Comparison of acupressure and knee brace position in correcting breech presentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primi gravida women and pregnant women with a history of normal vaginal delivery Age 18 years and above Gestational age: 32 to 35 weeks based on the first sonography or the first day of the last menstural period Proof of Breech presentation with sonography confirmation Single pregnancy Lack of prior experience in the use of acupressure
Exclusion criteria:
Pelvic defects Previous uterine surgery Uterine abnormalities Uterine fibroma with a diameter of more than 4 cm Presence of fetal abnormalities Twin pregnancy Tocolytic therapy during pregnancy Risk of preterm laber (short cervix and cerclage, etc.) High risk pregnancy (such as intrauterine growth retardation, placenta previa, polyhydramnios, oligohydramnios) Ensure that the intervention is not correctly performed by the samples or is not continuous
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to the study groups randomly with the six blocks and Persons will be assigned to three groups B, A, and C. Randomization will be done secretly; This means that 120 envelopes are prepared in a package and each code A, B and C is placed. After explaining the purpose of the study and obtaining the informed consent of the client, one of the envelopes will be removed in the specified order and action will be taken based on the group registered in the envelope.
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 Shahroud University of Medical Sciences
Street address
7 Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.SHMU.REC.1399.169

Health conditions studied

1

Description of health condition studied
Breach presentation
ICD-10 code
O32.1
ICD-10 code description
Maternal care for breech presentation

Primary outcomes

1

Description
Change the breech presentation
Timepoint
14 days
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, on the first day of the study, after completing a researcher-made questionnaire; Acupressure is performed on the BL67 spot (located on the outer corner of the small toe nail). The intervention is performed on a daily basis for 20 minutes (10 minutes on each leg) at any time of the day and in any situation where the pregnant mother feels comfortable . Each intervention period includes 10 seconds of pressure and 2 seconds of rest. All research samples are requested to go to doing sonography for 2 weeks later
Category
Other

2

Description
Category
empty

3

Description
Intervention group: Knee-chest position should be done for 32 days in 32-35 weeks of pregnancy for 14 days, 3 times a day (morning before getting out of bed with a full bladder, noon and night before bed) for 10-15 minutes. The mother is advised to do this on an empty stomach and write down the condition and time. All research samples are requested to go to doing sonography for 2 weeks later
Category
Other

4

Description
Control group: The research samples complete the researcher-made questionnaire on the first day of the study and after that, they receive only routine pregnancy care and All research samples are requested to go to doing sonography for 2 weeks later.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Clinic Bahar
Full name of responsible person
Foladi Mojtaba
Street address
Hospital Clinic Bahar, 22 Bahman Avenue, City Shahroud, State Semnan, Country Iran
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3222 7608
Email
info@shmu.ac.ir

2

Recruitment center
Name of recruitment center
Private office of Dr. Kolahdoozan
Full name of responsible person
Kolahdoozan Sakine
Street address
The Shafa Building of Physicians, 22 Bahman Avenue, City Shahroud, State Semnan, Country Iran
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3222 2854
Email
sakolahdozan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
7 Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Azam Hamidzadeh
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
7 Tir Square, City Shahroud, State Semnan, Country Iran
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
azhamidzade@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
7 Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
kiani.m89@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Faculty of member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
7 Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
kiani.m89@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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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