Clinical trial NCT03447015: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: ambulation
labour
Randomized Controlled Trial
Jordan
Lead sponsor: Mutah University
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: Duration of the First Stage of Labour
timeFrame: from 3-4 cm of cervical dilatation until delivery of the child.
measure: Labour Pain Intensity
timeFrame: from time of 4 cm cervical dilatation to to time of full crvical dilatation
measure: Use of Analgesics
timeFrame: 24 to 48 hours after birth.
measure: Mode of Birth
timeFrame: assessed up to child delivery
measure: Woman's Satisfaction With the Birth Experience
timeFrame: 24 to 48 hours after birth.
Secondary outcomes:
measure: Newborn Health Status
timeFrame: at 5 min of birth of baby
Other outcomes:
Locations:
city: Karak
country: Jordan
facility: Ministry Of Health
Study officials:
affiliation: Mutah University
name: Reham M Khresheh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
citation: Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Oct 9;2013(10):CD003934. doi: 10.1002/14651858.CD003934.pub4.
citation: Ministry of Health. Health Indicators.http://www.moh.gov.jo/reports. Retrieved 30 September, 2017.
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citation: 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
citation: Romano AM, Lothian JA. Promoting, protecting, and supporting normal birth: a look at the evidence. J Obstet Gynecol Neonatal Nurs. 2008 Jan-Feb;37(1):94-104; quiz 104-5. doi: 10.1111/j.1552-6909.2007.00210.x.
citation: 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
citation: Shaban IA, Hatamleh R, Khresheh R, Homer C. Childbirth practices in Jordanian public hospitals: consistency with evidence-based maternity care? Int J Evid Based Healthc. 2011 Mar;9(1):25-31. doi: 10.1111/j.1744-1609.2010.00197.x.
citation: Simkin P, Bolding A. Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. J Midwifery Womens Health. 2004 Nov-Dec;49(6):489-504. doi: 10.1016/j.jmwh.2004.07.007.
citation: Souza JP, Miquelutti MA, Cecatti JG, Makuch MY. Maternal position during the first stage of labor: a systematic review. Reprod Health. 2006 Nov 30;3:10. doi: 10.1186/1742-4755-3-10.
citation: Sweidan M, Mahfoud Z, DeJong J. Hospital policies and practices concerning normal childbirth in Jordan. Stud Fam Plann. 2008 Mar;39(1):59-68. doi: 10.1111/j.1728-4465.2008.00151.x.
citation: WHO. Care in normal birth: Apractical guide,1996 .http://www.who.int/maternal_child_adolescent/documents/who_frh_msm_9624/en/.