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The effectiveness of implementation of evidence based clinical practices on mother and newborn outcomes during normal labor and delivery

Protocol summary

Summary
A single-blind, randomized controlled clinical trial will be conducted between May and September 2014 at Shahid Beheshti hospital, affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. This study was approved by the ethics committee at the Isfahan University of Medical Sciences. The aim of this study is to compare the effect of «evidence based care» with «routine care » on mother and newborn outcomes during normal labor and delivery. Two hundred low risk pregnant women aged 18-35 years will be randomly allocated to receive either «evidence based care» or «routine care». One hundred were allocated to intervention group and 100 to control group. The main outcome of the study including duration of active phase and second stage of labor, labor Pain intensity, frequency use of oxytocin during normal labor, frequency use of routine episiotomy, postpartum hemorrhage, spontaneous tears in perinea and vagina, method of delivery, average time of admission to discharge, mother’s satisfaction of delivery, newborns Apgar score, frequency newborns admission to neonatal ward or NICU, breast feeding during 30 minute after birth.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050411360N1
Registration date: 2014-05-11, 1393/02/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Mina Iravani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 322 2899
Email address
iravani-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of implementation of evidence based clinical practices on mother and newborn outcomes during normal labor and delivery
Public title
Evidence Based Labor and Normal Delivery Management: A Mixed Methods Study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: intend to participation in study; low risk pregnant women; maternal age 18-35 years old; single pregnancy; gestational age 38-42 weeks; vertex presentation; spontaneous labor pain; vaginal dilatation between 3 and 4 centimeter; mother BMI 19.8-26 kg/m2; estimated fetal weight 2500-4000 gr. Exclusion criterion: unwillingness or reject of participation in study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Isfahan University of Medical Sciences
Street address
Research Dupty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran.
City
Isfahan
Postal code
8174673461
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
391206

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
Duration of active phase and second stage of labor
Timepoint
Cervix dilatation from 4 centimeter to 10 centimeter for active phase of labor and cervix dilatation from 10 centimeter to delivery of newborn for second stage of labor
Method of measurement
Clinical examination/ Measurement by digital chronometer / record in check list

2

Description
Labor Pain intensity
Timepoint
Measurement severity of pain during first and second stage of labor
Method of measurement
By visual analog scale/ record in check list

3

Description
Frequency use of oxytocin during normal labor
Timepoint
During first and second stage of normal labor
Method of measurement
Observation / record in check list

4

Description
Frequency use of routine episiotomy
Timepoint
Before of delivery
Method of measurement
Observation and record in check list

5

Description
Post partum hemorrhage
Timepoint
After childbirth
Method of measurement
Measurement of HG and HCT level by blood sampling 12 and 24 h after childbirth

6

Description
Spontaneous tears in perinea and vagina
Timepoint
After of delivery
Method of measurement
Observation / clinical examination/ record in check list

7

Description
Method of delivery
Timepoint
After of delivery
Method of measurement
Observation and record in check list

8

Description
Mother’s satisfaction of delivery
Timepoint
Before discharging of hospital
Method of measurement
Macky satisfaction questionnaire

9

Description
Apgar score
Timepoint
1 and 5 minute after of delivery
Method of measurement
Observation and record in check list

10

Description
Frequency newborn admission to neonatal ward or NICU
Timepoint
After of delivery
Method of measurement
Observation and record in check list

11

Description
Breast feeding during 30 min after birth
Timepoint
during30 min after birth
Method of measurement
Observation and record in check list

12

Description
Average time of admission to discharge of mother
Timepoint
Of admission time to discharge
Method of measurement
Measurement by Digital chronometer / record in check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The subjects in this group will receive evidence based care during normal labor and delivery
Category
Other

2

Description
Control group: This group will be received routine care of hospital during normal labor and delivery
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Medical and Training Hospital of Isfahan University of Medical Sciences
Full name of responsible person
Mrs. Mina Iravani and Dr. Elahe Zarean
Street address
Beheshti Hospital of Isfahan University of Medical Sciences, Pol Felezi- Motaheri Street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Research Dupty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Grant name
فصل دوم برنامه تحقیقات دانشگاهی
Grant code / Reference number
10506-1191
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Mina Iravani
Position
PhD candidate in Reproductive Health
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan University of Medical Sciences, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
minairavani2004@yahoo.com; minairavani2004@gmail.com
Web page address
http:/nm.mui.ac.irا

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences,Isfahan,iran
Full name of responsible person
Mina Iravani, Dr. Elahe Zarean, Dr.Mohsen Janghorbani
Position
PhD candidate in Reproductive Health; Assistant Professor-Fellowship in Prinatology; Professor in Ep
Other areas of specialty/work
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran-Department of Epidemiology, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
8144503500
Phone
+98 31 1792 2774
Fax
+98 31 1669 9398
Email
minairavani2004@yahoo.com; minairavani2004@ gmail.com; zarean.elahe@gmail.com; zarean@med.mui.ac.ir;
Web page address
http:/nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Nursing and Midwiffery School
Full name of responsible person
Mina Iravani
Position
PhD candidate in Reproductive Health
Other areas of specialty/work
Street address
Faculty of nursing and midwifery- Isfahan University of Medical Sciences, Isfahan,iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
minairavani2004@yahoo.com
Web page address
http:/nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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