Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
ambulation
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring ambulation, labour, Randomized Controlled Trial, Jordan
Eligibility Criteria
Inclusion Criteria:
- primiparous women
- with uncomplicated singleton pregnancies
- between 37 and 41 weeks gestation, cephalic, with cervical dilatation 3 to 5cm
Exclusion Criteria:
- multiparous
- with complicated pregnancies , multiple gestation,
Sites / Locations
- Ministry Of Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ambulation during labour
Standard Maternity care
Arm Description
women will be encouraged to ambulate "Ambulation during labour" here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).
women will receive usual maternity care.
Outcomes
Primary Outcome Measures
Duration of the First Stage of Labour
Labour duration will be measured in minutes.
Labour Pain Intensity
Visual Analogue pain Scale rating from 0 to 10 in which the woman registers the pain perception, considering 0 no pain and 10 the worst pain imaginable.)
Use of Analgesics
used analgesics or did not use
Mode of Birth
(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
Woman's Satisfaction With the Birth Experience
Birth satisfaction scale is a Likert-type scale which is scored according to the responses as indicated: I Strongly Agree. 5; I Agree. 4; I Neither Agree or Disagree: 3; • I Disagree.2; • I Strongly Disagree: 1. The scale consists of 30 items, and total number of scores to be obtained from the scale range between 30, and 150 points. As the scores obtained from the scale increase, level of birth satisfaction increases.
Secondary Outcome Measures
Newborn Health Status
measured by Apgar score. Apgar score is a method to quickly summarize the health of newborn. The Apgar scale is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03447015
Brief Title
Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes
Official Title
Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mutah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the effect of ambulation (walking) during first stage of labour on maternal and neonatal outcomes. In the intervention group women will be encouraged to ambulate and women in the control group will receive usual maternity care.
Detailed Description
Walking and upright positions in the first stage of labour reduces the duration of labour, the risk of caesarean birth, and the need for epidurals. Movement is a safe and healthy coping strategy for pain, and confining labouring women to bed increases pain and decreases women's satisfaction with their birth experience . Despite that ambulation and upright positioning during labour does not harm mother, fetus, or newborn, women are still largely confined to bed during the first stage of labour. The increased use of medical interventions such as epidural analgesia, continuous electronic fetal monitoring, intravenous infusions for fluids and electrolytes, and a restrictive birthing environment limits women's instinctive responses to labour pain and contractions rather than assisting the woman to cope with the pain and anxiety of labour .
In Jordan practices in maternity wards are not based on best evidence.The majority of health facilities restrict movement during labour, women were confined to bed in the lithotomy position and most of these facilities strap women in the delivery position, women have no choice to assume the position they prefer during labour and delivery. The practice of restricting women's movement in labour is contrary to the statements and recommendations of professional organizations advocate for women to move about during the first stage of labour, as long as they remain low-risk. Implementing evidence-based maternity care in developing countries with limited resources such as Jordan is particularly challenging, and requires commitment to applying the most up to date evidence to clinical decisions.
The purpose of this study is to begin investigation that could help provide a better quality of care during birth and improve maternity outcomes in one Jordanian hospital. The process was introducing an evidence-based practice of encouraging women to ambulate and assume the upright position during the first stage of labour and observing if results would suggest low cost modifications for the maternity health service environment, especially the labour ward. This is the first study that has attempted to implement and evaluate such an intervention in Jordan.
Methods A randomised controlled study will be conducted with primiparous women who come to give birth at Al- Karak Hospital in Jordan. Women will be subsequently randomised into the groups using a table of random numbers. "Ambulation during labour" here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).
The setting for this study will be the maternity ward at Al-Karak hospital, the main governmental and teaching hospital in the southern region of Jordan. In 2016 2,808 births occurred in this hospital, 59% were caesarean births . In this hospital, the woman usually labours in 26- bed ward with restrictions on movement. This is consistent practice nationally. Certified midwives, resident physicians, and obstetricians provide care. Midwives in this hospital work with uncomplicated labours and help obstetricians with complicated cases.
The sample size was calculated using the G power version 3.1. Based on difference between two independent groups, alpha= 0.05, median effect size 0.3, power =95%, sample size required for each group is 88 women. To overcome attrition, 25% of the calculated sample will be added, the final sample size will be 110 women in each group.
Data will be collected using structured tool developed by the researchers based on literature review of research related to the current topic. The tool composed of section collecting the socio-demographic data and another section collecting maternal and neonatal outcomes. The research tool was reviewed by a panel (n=3) of experts in maternity health field. Before starting the study, the final version of the tool will be tested in a pilot study to evaluate its feasibility, clarity, and reliability. Assistant researcher (midwife) will complete the first section of the tool, which related to socio-demographic data, and will allocate participants to control and intervention group according to the randomization list. The principal researcher will be kept blind for those participants who are in the intervention and control groups. Completing the second part of the study tool, which is related to maternal and infant health outcomes, will be in maternal ward and by the primary investigators 24 to 48 hours after birth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
ambulation, labour, Randomized Controlled Trial, Jordan
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised controlled study will be conducted with primiparous women. In the intervention group women will be encouraged to ambulate and women in the control group will receive usual maternity care
Masking
Investigator
Masking Description
The principal researcher will be kept blind for those participants who are in the intervention and control groups. Completing the second part of the study tool, which is related to maternal and infant health outcomes, will be in maternal ward and by the primary investigators 24 to 48 hours after birth.
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ambulation during labour
Arm Type
Experimental
Arm Description
women will be encouraged to ambulate "Ambulation during labour" here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).
Arm Title
Standard Maternity care
Arm Type
No Intervention
Arm Description
women will receive usual maternity care.
Intervention Type
Other
Intervention Name(s)
ambulation
Intervention Description
"Ambulation during labour" here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking).
Primary Outcome Measure Information:
Title
Duration of the First Stage of Labour
Description
Labour duration will be measured in minutes.
Time Frame
from 3-4 cm of cervical dilatation until delivery of the child.
Title
Labour Pain Intensity
Description
Visual Analogue pain Scale rating from 0 to 10 in which the woman registers the pain perception, considering 0 no pain and 10 the worst pain imaginable.)
Time Frame
from time of 4 cm cervical dilatation to to time of full crvical dilatation
Title
Use of Analgesics
Description
used analgesics or did not use
Time Frame
24 to 48 hours after birth.
Title
Mode of Birth
Description
(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
Time Frame
assessed up to child delivery
Title
Woman's Satisfaction With the Birth Experience
Description
Birth satisfaction scale is a Likert-type scale which is scored according to the responses as indicated: I Strongly Agree. 5; I Agree. 4; I Neither Agree or Disagree: 3; • I Disagree.2; • I Strongly Disagree: 1. The scale consists of 30 items, and total number of scores to be obtained from the scale range between 30, and 150 points. As the scores obtained from the scale increase, level of birth satisfaction increases.
Time Frame
24 to 48 hours after birth.
Secondary Outcome Measure Information:
Title
Newborn Health Status
Description
measured by Apgar score. Apgar score is a method to quickly summarize the health of newborn. The Apgar scale is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low
Time Frame
at 5 min of birth of baby
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All primiparous women with uncomplicated singleton pregnancies between 37 and 41 weeks gestation, cephalic, with cervical dilatation 3 to 5cm who come to give birth at Al-Karak hospital, between the 1st of January and the 30th of December 2018 will be approached for participation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primiparous women
with uncomplicated singleton pregnancies
between 37 and 41 weeks gestation, cephalic, with cervical dilatation 3 to 5cm
Exclusion Criteria:
multiparous
with complicated pregnancies , multiple gestation,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham M Khresheh, PhD
Organizational Affiliation
Mutah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry Of Health
City
Karak
ZIP/Postal Code
61166
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Bala, I., M. Babu, et al. Effectiveness of Back Massage versus Ambulation During First Stage of Labour among Primigravida Mothers in Terms of Pain and Anxiety. International Journal of Nursing Education 9(3): 28-32, 2017
Results Reference
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PubMed Identifier
18155816
Citation
Khresheh R, Homer C, Barclay L. A comparison of labour and birth outcomes in Jordan with WHO guidelines: a descriptive study using a new birth record. Midwifery. 2009 Dec;25(6):e11-8. doi: 10.1016/j.midw.2007.10.007. Epub 2007 Dec 26.
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Results Reference
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Ministry of Health. Health Indicators.http://www.moh.gov.jo/reports. Retrieved 30 September, 2017.
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Citation
Miquelutti, M. A., J. G. Cecatti, et al. The vertical position during labor: pain and satisfaction. Revista Brasileira de Saúde Materno Infantil 9 (4): 393-398, 2009
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Prabhakar, D., L. S. George, et al. Effectiveness of Ambulation during First Stage of Labour, on the Outcome of Labour among Primigravid Women in Selected Hospitals of Palakkad District, Kerala. International Journal of Nursing Education 7(1): 1-6,2015
Results Reference
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Savitha, V., S. Nayak, et al. Effect of Ambulation during First Stage of Labor on Labor Pain and Outcome of Labor among the Primigravida Mothers in a Selected Hospital Mangalore. Journal of South Asian Federation of Obstetrics and Gyneacology 5(1): 1-3, 2013
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Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes
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