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Labor PainNCT03447015

Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes

A study testing ambulation in people with Labor Pain, run by Mutah University at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain
What is being tested?
ambulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteJordan
Study dates
1 Mar 2018to 20 Feb 2019
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • primiparous women
  • with uncomplicated singleton pregnancies
  • between 37 and 41 weeks gestation, cephalic, with cervical dilatation 3 to 5cm

Who cannot join

  • multiparous
  • with complicated pregnancies , multiple gestation,

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • Ministry Of Health

    Karak, 61166

Other trials in Jordan

About this study

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.

Read the 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.

Conditions
Labor Pain
Being tested
ambulation
Keywords
ambulation, labour, Randomized Controlled Trial, Jordan
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ambulationOther

    "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).

Study groups in NCT03447015
Study groupRoleWhat they receive
Ambulation during labourExperimentalwomen 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).
Receives: Other: ambulation
Standard Maternity careNo interventionwomen will receive usual maternity care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of the First Stage of Labour

    Labour duration will be measured in minutes.

    Measured: from 3-4 cm of cervical dilatation until delivery of the child.

  2. 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.)

    Measured: from time of 4 cm cervical dilatation to to time of full crvical dilatation

  3. Use of Analgesics

    used analgesics or did not use

    Measured: 24 to 48 hours after birth.

  4. Mode of Birth

    (defined as normal, vacuum extraction, forceps delivery, or cesarean section)

    Measured: assessed up to child delivery

  5. 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.

    Measured: 24 to 48 hours after birth.

Secondary outcomes (1)
  1. 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

    Measured: at 5 min of birth of baby

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start1 Mar 2018
  3. Primary completion20 Feb 2019
  4. Study completion20 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Investigator
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03447015
Sponsor's protocol ID
112018
Status last verified
Sep 2019
First submitted
12 Feb 2018
Last updated
6 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 18155816
  • 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.

    PubMed 24105444
  • Ministry of Health. Health Indicators.http://www.moh.gov.jo/reports. Retrieved 30 September, 2017.

  • 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

  • Ondeck M. Healthy birth practice #2: walk, move around, and change positions throughout labor. J Perinat Educ. 2014 Fall;23(4):188-93. doi: 10.1891/1058-1243.23.4.188.

    PubMed 25411538
  • 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

  • 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.

    PubMed 18226163
  • 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

  • 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.

    PubMed 21332660
  • 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.

    PubMed 15544978
  • 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.

    PubMed 17137501
  • 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.

    PubMed 18540524
  • WHO. Care in normal birth: Apractical guide,1996 .http://www.who.int/maternal_child_adolescent/documents/who_frh_msm_9624/en/.

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