NCT03447015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 11, 2019

Completed
Last Updated

December 6, 2024

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

February 12, 2018

Results QC Date

March 13, 2019

Last Update Submit

November 19, 2024

Conditions

Keywords

ambulationlabourRandomized Controlled TrialJordan

Outcome Measures

Primary Outcomes (5)

  • Duration of the First Stage of Labour

    Labour duration will be measured in minutes.

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

  • 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.)

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

  • Use of Analgesics

    used analgesics or did not use

    24 to 48 hours after birth.

  • Mode of Birth

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

    assessed up to child delivery

  • 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.

    24 to 48 hours after birth.

Secondary Outcomes (1)

  • Newborn Health Status

    at 5 min of birth of baby

Study Arms (2)

Ambulation during labour

EXPERIMENTAL

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).

Other: ambulation

Standard Maternity care

NO INTERVENTION

women will receive usual maternity care.

Interventions

"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).

Ambulation during labour

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll 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
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • multiparous
  • with complicated pregnancies , multiple gestation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry Of Health

Karak, 61166, Jordan

Location

Related Publications (14)

  • 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

    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.

    PMID: 18155816BACKGROUND
  • 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.

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

    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

    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.

    PMID: 25411538BACKGROUND
  • 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

    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.

    PMID: 18226163BACKGROUND
  • 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

    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.

    PMID: 21332660BACKGROUND
  • 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.

    PMID: 15544978BACKGROUND
  • 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.

    PMID: 17137501BACKGROUND
  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Walking

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Dr Reham Khresheh
Organization
Mutah University

Study Officials

  • Reham M Khresheh, PhD

    Mutah University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Reham Khresheh

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 27, 2018

Study Start

March 1, 2018

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

December 6, 2024

Results First Posted

October 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations