Objective: The effect of knee chest position on turning breech to cephalic presentation in pregnant women. Design: A clinical trial on 84 pregnant women referred to health centers and hospital clinics in Mashhad. Samples will be divided randomly into the intervention group and the control and sampling will be easy. The main inclusion and exclusion criteria: gestational age 36-34 weeks, single fetus, breech presentation. Intervention: Intervention group: Pregnant women will be placed in the position of the knee chest for 10 days, three times in day (morning before getting out of bed, noon and evening before bedtime). The control group will receive routine care. In both groups, fetal presentation will be determined with Leopold maneuver and ultrasound ten days later. In both groups, type of delivery and fetal presentation will be followed at the time of delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092129905N1
Registration date:2017-08-21, 1396/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Maryam Tafazzolifar
Name of organization / entity
Mashhah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38412081051
Email address
tafazzolim931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-08, 1395/08/18
Expected recruitment end date
2017-07-09, 1396/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of knee chest position on turning breech to cephalic presentation in pregnant women
Public title
Effect of knee chest position on turning breech to cephalic presentation in pregnant women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: the gestational age of 36-34 weeks; breech presentation; singleton pregnancy; no contraindications for vaginal delivery (Placenta previa, previous uterine surgery, previous cesarean); Not having a history of illness (Heart disease, Respiratory disease; liver disease; kidney disease, Hypertension, Eclampsia, Gestational diabetes); the absence of obstetrical complication (uterine anomalies and external genital system, bleeding in the third trimester and premature rupture of membranes, risk of Rhesus iso-immunization, intrauterine growth restriction, fetal malformations, Polyhydramnios and Oligohydramnios); Body mass index does not equal to 30 or higher. Exclusion: not willingness to participate in research; knee chest position program not done for four times or more; preterm labor; Occurrence of obstetrical and medical complications.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Mashhad University of Medical Sciences
Street address
Daneshgah Street, Qureshi Building, Administration Mashhad University of Medical Sciences
City
Mashhad
Postal code
13944-91388
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.MUMS.REC.1395.270
Health conditions studied
1
Description of health condition studied
Breech presentation
ICD-10 code
O32.1
ICD-10 code description
Maternal care for breech presentation
Primary outcomes
1
Description
Turning Breech to Cephalic presentation
Timepoint
10 days after intervention and time of delivery
Method of measurement
Leopold maneuvers and Ultrasound
Secondary outcomes
1
Description
Fetal movement
Timepoint
From the time of entry to study for ten days
Method of measurement
Counting the fetal movement by mother
Intervention groups
1
Description
Knee chest position will be taught to the intervention group and mother for 10 days, 3 times a day (morning: before getting out of bed, noon, evening: before bed), each time for 15-10 minutes. The fetal presentation will be checked after 10 days and at the time of delivery.
Category
Other
2
Description
Control group will not be taught the knee chest position. Care routine without any intervention will be done for mother. The fetal presentation will be checked after 10 days and at the time of delivery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Health centers
Full name of responsible person
Mis Rezai
Street address
Northern Tabarsi 28
City
Mashhad
2
Recruitment center
Name of recruitment center
Forozanfar Helth Center
Full name of responsible person
Mis Zarei
Street address
Panjtan 14
City
Mashhad
3
Recruitment center
Name of recruitment center
Mofateh Helth Center
Full name of responsible person
Mis Katebi
Street address
Tabatabae 21
City
Mashhad
4
Recruitment center
Name of recruitment center
Alteimor Helth Center
Full name of responsible person
Mis sherbaf
Street address
Panjtan 62
City
Mashhad
5
Recruitment center
Name of recruitment center
Karrgaran Helth Center
Full name of responsible person
Mis Madahi
Street address
CHaman 19
City
Mashhad
6
Recruitment center
Name of recruitment center
22Bahman Helth Center
Full name of responsible person
Mis Rajabzadeh
Street address
Mohammad Abad 32
City
Mashhad
7
Recruitment center
Name of recruitment center
Ansar Helth Center
Full name of responsible person
Mis Motamedi
Street address
Northern Tabarsi 4
City
Mashhad
8
Recruitment center
Name of recruitment center
Imam Hadi Helth Center
Full name of responsible person
Mis Mosavi
Street address
Mohebi 47
City
Mashhad
9
Recruitment center
Name of recruitment center
CHamran Helth Center
Full name of responsible person
Mis Hoseini
Street address
22Bahman 14
City
Mashhad
10
Recruitment center
Name of recruitment center
Rasol Akram Helth Center
Full name of responsible person
Mis saeadi
Street address
Kashani 1
City
Mashhad
11
Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Mis Tafazoli
Street address
Hashemi Nejad 19/1
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Qureshi Bulding
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Tafazzolifar
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
Ebnesina Street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
tafazzolim931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masomeh Kordi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ebnesina Street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
kordim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Tafazzolifar
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
Ebnesina Street,School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
Fax
Email
tafazzolim931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)