Labor Pain Clinical Trial
Official title:
Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes: A Randomized Controlled Trial
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.
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.
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