Protocol summary

Summary
We designed a randomised clinical trial to evaluate the efficacy of maternal position in labor to correct occipito-posterior fetal position and delivery outcome. A total of 180 women entered the study based on inclusion and exclusion criteria. Occipitoposterior position of fetal head in all of the samples was confirmed using ultrasound. Participants were randomly assigned into one of three groups: Forty five women were selected to the intervention group one: they spent 15-30 minutes per hour of labor in a semi prone position. Forty five women were selected to the intervention group two: they spent 15-30 minutes per hour of labor in a knee-chest position. Ninety women were selected to the control group that they spent more of their labor in current position (recumbent or supine). The most important outcomes of the study including the determination of occipitoanterior position; fetal head position at delivery; duration of active phase and second stage of labor; type of delivery; perineal trauma; the severity of labor Pain; frequency use of oxytocin during labor; frequency use of routine episiotomy; mother’s satisfaction from her position and newborn apgar score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082111360N3
Registration date: 2017-11-13, 1396/08/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-13, 1396/08/22
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
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-02, 1396/02/12
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of maternal positionin labor to correct occipito-posterior fetal position and delivery outcome
Public title
The efficacy of maternal positionin labor to correct occipito-posterior fetal position and delivery outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women were active labor; age bteween18-40 years; BMI between 18 and 30 Kg/m2; assessment of occiput fetal position at the labour onset and confirmed by ultrasound; singleton pregnancy; cephalic fetal presentation and gestational age more than 37 week. Exclusion criteria: labour induction; complications of pregnancy; any contraindication for use of knee-chest and semi prone position.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan, Farvardin street, Khuuzestan,Ahvaz 61357-33118
City
Ahvaz
Postal code
15794-61357
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.AJUMS.REC.1396.85

Health conditions studied

1

Description of health condition studied
Normal Delivery Manangment
ICD-10 code
0.80
ICD-10 code description
Normal 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 for dillatation of 4; 6; 8 and 10 centimeter and secod stage
Method of measurement
By visual analog scale and mc gill questionnaire/ record in check list

3

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

4

Description
Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Observation and examination

5

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

6

Description
Mother satisfaction from delivery
Timepoint
after delivery
Method of measurement
Macky satisfaction questionnaire

7

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

8

Description
Frequency of third and fourth-degree perineal lacerations
Timepoint
After of delivery
Method of measurement
Observation and record in check list

9

Description
Fetal head position at birth
Timepoint
At delivery
Method of measurement
Observation and record in check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Semi prone position
Category
Other

2

Description
control group: current position (supine position)
Category
Other

3

Description
Intervention group 2: Knee-chest position
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother hospital ramhormoz
Full name of responsible person
Kobra bahmaei
Street address
Mother hospital ramhormoz khouzestan Iran
City
ramhormoz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharif MakhmalZade
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
Ahvaz
Grant name
RHPRC-9601
Grant code / Reference number
RHPRC-9601
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Jundishapur 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
Ahvaz Jundishapuur University of Medical Sciences
Full name of responsible person
Kobra bahmaei
Position
ms midwifery student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mina Iravani
Position
Ph.D of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jondishapour University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3373 8538
Fax
+98 61 3373 8333
Email
iravani-m@ajums.ac.i; rminairavani2004@yahoo.com
Web page address
http://ajums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Mina Iravani
Position
Ph.D of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3373 8395
Fax
+98 61 3373 8333
Email
iravani-m@ajums.ac.ir; minairavani2004@yahoo.com
Web page address
http://ajums.ac.ir/

Sharing plan

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