Objective: We aim to determine the effect of physiological birth in outcomes of delivery, including type of delivery, fear of delivery, pain of labor and apgar of neonate. Methods: A randomized controlled trial will complete on 160 women who admitting at Fatemieh hospital in Hamedan, Iran. 80 will allocate to physiological birth (intervention group) and 80 to routine vaginal birth (control group). The study population included all pregnant women with gestational age between 37 and 42 weeks; singleton pregnancy; live fetus; cephalic presentation; maternal age 18-45 years; and vaginal dilatation between 3 and 4 centimeter in examination room. In the intervention group education for physiological delivery are given in the 20 th week of pregnancy for 8 weeks (one session per week). In this group, breathing techniques and relaxation training and exercise, nutrition during pregnancy and coping with stress is given. In the intervention group, during labor and delivery, the midwife will be along with mother and episiotomy incision is not given. But in the control group routine prenatal care will be performed and episiotomy may be given. The data collection instruments are included three questionnaires. Fear of delivery questionnaire, type of delivery check list, visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072713405N4
Registration date:2014-11-14, 1393/08/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-14, 1393/08/23
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education of physiological delivery in reducing the cesarean rate in pregnant women
Public title
The effect of physiological birth on reduction of cesarean delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:No prohibition of normal vaginal delivery; no known physical and mental illness; the absence of high risk pregnancy for example blood pressure 140.90 and higher, preeclampsia, polyhydramniosis and oligohydramniosis; absence of cesarean section history or any uterine scar and placenta previa; Lack of prolonged rupture of membranes more than 18 hours before delivery; estimation of fetal weight between 2500-4000 gr; absence of fetal congenital anomalies identified by ultrasound in perinatal Exclusion criteria:Blood pressure 140.90mmHg and higher during the intervention; failure to attend more than one session of training
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Vice chancellor for research and technology,Hamedan University of Medical Sciences
Street address
Fahmideh Ave, Vice chancellor for research and technology, Hamedan University of Medical Sciences
City
Hamedan
Postal code
6516645977
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
16/35/9/3962/د/پ
Health conditions studied
1
Description of health condition studied
Relationship between education of physiological delivery and reducing cesaren birth
ICD-10 code
O80.0
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Type of delivery
Timepoint
Immediately after delivery
Method of measurement
Questionnaire
2
Description
Fear of delivery
Timepoint
Before education and after delivery
Method of measurement
Questionnaire
3
Description
Pain of delivery
Timepoint
After delivery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Apgar
Timepoint
After delivery
Method of measurement
Check list
Intervention groups
1
Description
Intevention group: physiological birth
Category
Prevention
2
Description
Control group: Routine normal delivery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research the Technology, Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashiriyan
Street address
Hamedan University of Medical Sciences, Fahmideh Ave, Hamedan,Iran
City
Hamedan
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 the Technology, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
PhD in reproductive health
Other areas of specialty/work
Street address
Fahmideh Ave, School of nursing and midwifery, Hamedan University of Medical Sciences, Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.it
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Fahmideh Ave, School of Nursing and Midwifery, Hamedan University of Medical Sciences, Hamedan, Iran
City
Hamedan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
Instructor, PhD of reproductive health
Other areas of specialty/work
Street address
Fahmideh Ave, Hamedan university of medical sciences, school of nursing and midwifery, Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)