Clinical trial with control group, with parallel groups, no blinding performed, randomization performed, 216 samples,By random block method and using 6 blocks
Settings and conduct
Sina hospital karoon
Participants/Inclusion and exclusion criteria
Gestational age≥ 37 weeks
Fetal head’s position is to be posterior occipital with the approval of ultrasound
Pregnancy is to be singleton
Maternal age’s range is to be 18-40
BMI is to be 18-30
Mother is to be at the onset of the labor pains and at the beginning of the active phase
of labor(Dilatation ≥ 4 cm)
Intervention groups
To ensure that each person's group is not disclosed, the allocation will be hidden by assigning unique codes to each of the subjects and placing them in dark envelopes.
The subjects in the intervention group, in addition to receiving routine midwifery care (examination, vital signs check, hearing of fetal heartbeat) until the time of delivery, were alternately in the lunge position for a period of 15 to 20 minutes per hour. The lung position refers to a position in which one of the legs is bent while standing and the floor is placed on a chair or a high level and the sole of the other foot is on the ground. Also, this position is such that the sole of one foot is on the ground and the knee of the other foot is on the ground in a position similar to squatting. In this position, the upper leg is located on the same side of the posterior occiput of the fetus. the control group will receive routine care.
Main outcome variables
Duration of active phase and second stage of labor؛ Labor Pain intensity؛ Type of delivery؛ Apgar score؛ Frequency use of oxytocin during normal labor؛ Mother satisfaction from delivery؛ Frequency use of episiotomy؛ Frequency of third and fourth-degree perineal lacerations؛ Fetal head position at birth
General information
Reason for update
Acronym
OP- occiput posterior
IRCT registration information
IRCT registration number:IRCT20220306054201N1
Registration date:2022-05-01, 1401/02/11
Registration timing:prospective
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
maryam hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 966 7076
Email address
mhamiddi76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of maternal lunge position during labor on rotation of posterior fetal occipital position and delivery outcome
Public title
effectiveness of maternal lunge position on rotation of posterior fetal occipital position and delivery outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age is to be 37 weeks or more.
Fetal head’s position is to be posterior occipital with the approval of ultrasound.
Pregnancy is to be singleton.
Maternal age’s range is to be 18-40.
BMI is to be 18-30.
Mother is to be at the onset of the labor pains and at the beginning of the active phase of labor(Dilatation equal to and greater than 4 cm).
Exclusion criteria:
High risk pregnancy(Fetal weight over 4000 g, preeclampsia, gestational diabetes, BMI above 30 in mother, history of heart disease in mother, history of respiratory disease in mother)
Prolonged pregnancy
History of previous cesarean delivery
Twin pregnancies and above
Existence of severe vaginal bleeding
Cases in which the active movement of the mother is prohibited in labor
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:
216
Randomization (investigator's opinion)
Randomized
Randomization description
32 blocks will be used. In each block of 6, 3 people will be assigned to the intervention group and 3 people to the control group, which will be arranged randomly. Thus, at the end of each block, there will be two balancing groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The lounge position refers to a position in which one of the legs is bent while standing and the floor is placed on a chair or a high level and the sole of the other foot is on the ground. Also, this position is such that the sole of one foot is on the ground and the knee of the other foot is on the ground in a position similar to squatting.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.AJUMS.REC.1400.693
Health conditions studied
1
Description of health condition studied
Normal Delivery Manangment
ICD-10 code
0.80
ICD-10 code description
زایمان طبیعی
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 dilatation of 4; 6; 8 and 10 centimeter and second stage
Method of measurement
By visual analog scale
3
Description
Type of delivery
Timepoint
After 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
Mackey Childbirth Satisfaction Rating Scale
7
Description
Frequency use of episiotomy
Timepoint
After delivery
Method of measurement
Observation and record in check list
8
Description
Frequency of third and fourth-degree perineal lacerations
Timepoint
After 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: lunge position
Category
Other
2
Description
Control group: current position
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital karoon
Full name of responsible person
Maryam hamidi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 936 966 7076
Email
mhamiddi76@gmail.com
Web page address
http://vchresearch.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh zakerkish
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
RHPRC-0030
Grant code / Reference number
RHPRC-0030
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam hamidi
Position
MS midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
mhamiddi76@gmail.com
Web page address
http://vchresearch.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mina Iravani
Position
Ph.D of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8538
Email
minairavani2004@yahoo.com
Web page address
http://ajums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mina Iravani
Position
Ph.D of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan Ahvaz Ahvaz Khuuzestan , Islamic Republic Of Iran
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8538
Email
minairavani2004@yahoo.com
Web page address
http://ajums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are currently no plans to publish it.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available