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

NCT ID: NCT03447015

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-02-20

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.

Conditions

Labor Pain

Keywords

ambulation; labour; Randomized Controlled Trial; Jordan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ambulation during labour

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).

Group Type: EXPERIMENTAL

ambulation

Intervention Type: OTHER

"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).

Standard Maternity care

women will receive usual maternity care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ambulation

"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).

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mutah University

OTHER

Sponsor Role: lead

Responsible Party

Reham Mohammad Khresheh

Dr. Reham Khresheh

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reham M Khresheh, PhD

Role: PRINCIPAL_INVESTIGATOR

Mutah University

Locations

Ministry Of Health

Karak, , Jordan

Countries

Jordan

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18155816 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24105444 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25411538 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18226163 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21332660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15544978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17137501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18540524 (View on PubMed)

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

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

112018

Identifier Type: -

Identifier Source: org_study_id