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

Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03447015
Enrollment
290
Registered
2018-02-27
Start date
2018-03-01
Completion date
2019-02-20
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

ambulation, labour, Randomized Controlled Trial, Jordan

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.

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).

Sponsors

Mutah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

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.

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
Use of Analgesics24 to 48 hours after birth.used analgesics or did not use
Mode of Birthassessed up to child delivery(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
Duration of the First Stage of Labourfrom 3-4 cm of cervical dilatation until delivery of the child.Labour duration will be measured in minutes.
Labour Pain Intensityfrom time of 4 cm cervical dilatation to to time of full crvical dilatationVisual 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.)
Woman's Satisfaction With the Birth Experience24 to 48 hours after birth.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.

Secondary

MeasureTime frameDescription
Newborn Health Statusat 5 min of birth of babymeasured 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

Countries

Jordan

Participant flow

Participants by arm

ArmCount
Intervention
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). 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).
95
Control
women will receive usual maternity care.
106
Total201

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Customized
<20
10 participants19 participants29 participants
Age, Customized
20-29
66 participants79 participants145 participants
Age, Customized
30-39
19 participants8 participants27 participants
Education
Bachelor
44 Participants22 Participants66 Participants
Education
Diploma
16 Participants22 Participants38 Participants
Education
illiterate
1 Participants21 Participants22 Participants
Education
primary school
11 Participants19 Participants30 Participants
Education
secondary school
23 Participants22 Participants45 Participants
Employment
employed
25 Participants17 Participants42 Participants
Employment
not employed
70 Participants89 Participants159 Participants
Health insurance
No
41 Participants51 Participants92 Participants
Health insurance
yes
54 Participants55 Participants109 Participants
monthly Income (Jordanian Dinar)
< 200
16 Participants21 Participants37 Participants
monthly Income (Jordanian Dinar)
200-399
11 Participants25 Participants36 Participants
monthly Income (Jordanian Dinar)
400-599
57 Participants55 Participants112 Participants
monthly Income (Jordanian Dinar)
600 and more
11 Participants5 Participants16 Participants
Nationality
Jordanian
85 Participants106 Participants191 Participants
Nationality
non Jordanian
10 Participants0 Participants10 Participants
Race and Ethnicity Not Collected0 Participants
Residence
city
50 Participants38 Participants88 Participants
Residence
village
45 Participants68 Participants113 Participants
Sex: Female, Male
Female
95 Participants106 Participants201 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 950 / 106
other
Total, other adverse events
0 / 950 / 106
serious
Total, serious adverse events
0 / 950 / 106

Outcome results

Primary

Duration of the First Stage of Labour

Labour duration will be measured in minutes.

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

ArmMeasureValue (MEAN)Dispersion
InterventionDuration of the First Stage of Labour548.337 minutesStandard Deviation 62.7841
ControlDuration of the First Stage of Labour719.585 minutesStandard Deviation 86.5829
Primary

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.)

Time frame: from time of 4 cm cervical dilatation to to time of full crvical dilatation

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionLabour Pain Intensityparticipants reporting pain intensity as moderate26 Participants
InterventionLabour Pain Intensityparticipants reporting pain intensity as severe57 Participants
InterventionLabour Pain Intensityparticipants reporting pain intensity very severe12 Participants
ControlLabour Pain Intensityparticipants reporting pain intensity as moderate9 Participants
ControlLabour Pain Intensityparticipants reporting pain intensity as severe62 Participants
ControlLabour Pain Intensityparticipants reporting pain intensity very severe35 Participants
Primary

Mode of Birth

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

Time frame: assessed up to child delivery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionMode of Birthnumber of participants who gave birth normal95 Participants
InterventionMode of Birthnumber of participants who gave birth by vacuum0 Participants
InterventionMode of Birthnumber of participants who gave birth bycesarean0 Participants
ControlMode of Birthnumber of participants who gave birth normal97 Participants
ControlMode of Birthnumber of participants who gave birth by vacuum5 Participants
ControlMode of Birthnumber of participants who gave birth bycesarean4 Participants
Primary

Use of Analgesics

used analgesics or did not use

Time frame: 24 to 48 hours after birth.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionUse of Analgesicsno51 Participants
InterventionUse of Analgesicsyes44 Participants
ControlUse of Analgesicsno24 Participants
ControlUse of Analgesicsyes82 Participants
Primary

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.

Time frame: 24 to 48 hours after birth.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionWoman's Satisfaction With the Birth ExperienceSatisfied89 Participants
InterventionWoman's Satisfaction With the Birth Experiencedissatisfied6 Participants
ControlWoman's Satisfaction With the Birth ExperienceSatisfied9 Participants
ControlWoman's Satisfaction With the Birth Experiencedissatisfied97 Participants
Secondary

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

Time frame: at 5 min of birth of baby

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNewborn Health StatusApgar score ≤ 32 Participants
InterventionNewborn Health StatusApgar score 4-62 Participants
InterventionNewborn Health StatusApgar score ≥791 Participants
ControlNewborn Health StatusApgar score ≤ 313 Participants
ControlNewborn Health StatusApgar score 4-610 Participants
ControlNewborn Health StatusApgar score ≥783 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026