The present study is a multi center randomized clinical trial designed to investigate the effect of acupressure on correction of Breech presentation. The research samples were randomly selected from primigravida mothers or with history of normal vaginal delivery, which at the gestational age of 32 to 35 weeks, their embryos presentation have reported in sonography, breech presentation, randomly are placed into two groups of intervention and control (There are 138 people in each group). Acupressure is performed in interventoin group on the BL67 spot on a daily basis for 20 minutes (10 minutes on each leg). Each intervention period consists of 10 seconds of pressure and 2 seconds of rest, respectively. The control group only receives routine pregnancy care. All research samples are requested to go to doing sonography for 2 weeks later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017093012198N5
Registration date:2017-10-31, 1396/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
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
Shahroud University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of acupressure on correction of breech presentation
Public title
Effect of acupressure on breech presentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primi gravida women and pregnant women with a history of normal vaginal delivery, age: 20-40 years, 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 and 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, high risk pregnancy such as intrauterine growth retardation, placenta previa, polyhydramnios, oligohydramnios and ensure that the intervention is not correctly performed by the samples or is not continuous.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahroud University of Medical Sciences
Street address
Shahroud, 7 Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
00
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.SHMU.REC.1396.38
Health conditions studied
1
Description of health condition studied
Breech presentation
ICD-10 code
032.1
ICD-10 code description
Maternal care for breech presentation
Primary outcomes
1
Description
Change of breech presentation
Timepoint
Two weeks later
Method of measurement
Sonography of embryo
Secondary outcomes
1
Description
Newborn weight
Timepoint
Delivery time
Method of measurement
Weighing scale
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 the time specified by the researcher. 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
In the control group, the research samples completed the researcher-made questionnaire on the first day of the study and after that they only receive 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
Clinic of Bahar Hospital
Full name of responsible person
Sedigheh Moghani
Street address
Shahroud, 22 Bahman Avenue, Bahar Hospital
City
Shahroud
2
Recruitment center
Name of recruitment center
Private office of Dr Kolahdoozan
Full name of responsible person
Dr Sakineh Kolahdoozan
Street address
Shahrood, 22 Bahman Avenue, The Shafa Building of Physicians
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammad Hasan Emamian
Street address
shahroud, 7 tir Square, research deputy
City
Shahroud
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Faculty of member
Other areas of specialty/work
Street address
Shahroud, 7 Tir Square, Shahroud University of Medical Sciences, School of nursing and Midwifery
City
Shahroud
Postal code
00
Phone
+98 23 3239 5054
Fax
00
Email
kiani.m89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Siences
Full name of responsible person
Azam Hamidzadeh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Shahroud, 7 Tir square, Shahroud University of Medical Sciences, School of Nursing and Midwifery
City
Shahroud
Postal code
00
Phone
+98 23 3239 5054
Fax
00
Email
azam_hamidzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Siences
Full name of responsible person
Mahdieh Kiani
Position
Faculty of member
Other areas of specialty/work
Street address
Shahroud, 7 Tir square, Shahroud University of Medical Siences, School of nursing and Midwifey
City
Shahroud
Postal code
00
Phone
+98 23 3239 5054
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)