The effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP): A randomized controlled trial
effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP)
Design
The study is a two-arm randomized clinical trial with a parallel design with a control group. The permutation block method will be used for randomization. The number of participants in each group is 26 people.
Settings and conduct
Location: Sina Ahvaz Hospital. There is no blinding. A delivery ball is provided to a group and routine care is provided to a group
Participants/Inclusion and exclusion criteria
inclusion criteria:
Pregnant women with spontaneous labor and posterior occiput fetus
exclusion criteria:
high Risk delivery
Intervention groups
Pelvic movements with the birthing ball in the intervention group
Routine labor care in the control group
Main outcome variables
The frequency of anterior head rotation in posterior occiput fetuses in the active phase of labor
The frequency of posterior occiput stable at the time of delivery
Cervical dilatation process
Cervical dilation process
The process of fetal head descent
Length of delivery
Oxytocin volume to enhance labor
Severity of labor pain
Type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090719002204N5
Registration date:2024-08-20, 1403/05/30
Registration timing:prospective
Last update:2024-08-20, 1403/05/30
Update count:0
Registration date
2024-08-20, 1403/05/30
Registrant information
Name
Somayeh Makvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 604 2247
Email address
s-makvandi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP): A randomized controlled trial
Public title
The effect of pelvic movements with the birth ball in the active phase of labor on the anterior rotation of the fetal head in cases of posterior occiput (OP): A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being interested in participating in the study
age of at least 18 years and a maximum of 45 years
low-risk pregnancy
able to understand the Persian language
primiparous and multiparous women
singleton fetus in vertex presentation
intact membranes
not suffering from diseases chronic
gestational age 37 to 42 weeks
normal pelvic examination (to remove the bias, all examinations will be performed by an experienced person with 20 years of clinical work in the maternity hospital)
4 cm dilation of the cervix
having at least three spontaneous uterine contractions of 40 seconds in ten minutes
spontaneous start of labor
estimation of fetal weight based on late pregnancy ultrasound between 2500 and 4000 grams/
position of the posterior occiput of the fetus during hospitalization in the active phase
Exclusion criteria:
previous cesarean
Occurrence of any dangerous symptoms that risk labor and require medical intervention
Withdrawal at any time from the study
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:
52
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the samples, we will use the "permutation block randomization" method using a reliable website to generate random sequences. 52 samples are assigned to two intervention (26 people) and control (26 people) groups. The random block sequence to determine the groups will be randomly generated using the randomization website www.sealedenvelope.com. The size of the blocks in this study will be different (4 blocks and 8 blocks) in order to create more variety in the allocation of samples.
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
Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794.
Approval date
2024-07-20, 1403/04/30
Ethics committee reference number
IR.AJUMS.REC.1403.170
Health conditions studied
1
Description of health condition studied
Position of the posterior occiput of the fetal head
ICD-10 code
O64.0
ICD-10 code description
Obstructed labor due to incomplete rotation of fetal head
Primary outcomes
1
Description
Frequency of anterior rotation of the fetal head
Timepoint
Every two hours
Method of measurement
Portable ultrasound
Secondary outcomes
1
Description
Cervical dilatation process
Timepoint
Every two hours
Method of measurement
Vaginal examination
2
Description
Cervical effacement process
Timepoint
Every two hours
Method of measurement
Vaginal examination
3
Description
first labor stage duration
Timepoint
at end of the first stage
Method of measurement
Partograph
4
Description
labor pain
Timepoint
every 2 hours
Method of measurement
visual analogue scale
5
Description
Persistent posterior occiput
Timepoint
At the time of delivery
Method of measurement
observation
Intervention groups
1
Description
Intervention group: pelvic movements with birth ball. In the intervention group, from dilation of 4 cm and in case of having three spontaneous contractions of the uterus in ten minutes with a duration of at least 40 seconds, pelvic exercises with a birthing ball will be started in such a way that the mother will spread her legs shoulder-width apart and sit on the ball. For safety and to prevent falling, he will hold the protective bar next to the bed with both hands. The researcher will also be behind him for more assurance. Pelvic movements on the ball will be circular movements and the direction of rotation will be determined by the position of the fetal head. Since the main objective of our study is the rotation of the fetal head towards the mother's front (OA); Therefore, in left posterior occiput (LOP) fetuses, the direction of pelvic rotation will be to the right (clockwise) and in right posterior occiput (ROP) fetuses, the direction of pelvic rotation will be to the left (counterclockwise).
Category
Treatment - Devices
2
Description
Control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Sina hospital
Full name of responsible person
Somayeh Makvandi
Street address
Karoon
City
Ahvaz
Province
Khouzestan
Postal code
00986135550591
Phone
+98 61 3555 0591
Email
Somayemakvandi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794.
Phone
+98 61 3311 4155
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
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
Dr. Somayeh Makavndi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794.
Phone
+98 916 604 2247
Email
somayemakvandi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Somayeh Makvandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794.
Phone
+98 916 604 2247
Email
somayemakvandi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Somayeh Makvandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794.
Phone
+98 916 604 2247
Email
somayemakvandi@gmail.com
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
no information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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