An interventional study of ambulation in Labor Pain, sponsored by Mutah University. Completed at 1 site in Jordan. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Mutah University · Not applicable, Interventional, and Supportive care
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.
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.
409 studies on the registry are indexed under Labor Pain; 69 are open to participants now.
This study's enrollment of 290 is above the median of 100 across 336 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Mutah University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
women will receive usual maternity care.
"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).
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.
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
Use of Analgesics
used analgesics or did not use
Time frame: 24 to 48 hours after birth.
Mode of Birth
(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
Time frame: 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.
Time frame: 24 to 48 hours after birth.
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
| Milestone | Intervention | Control |
|---|---|---|
| Started | 140 | 150 |
| Completed | 95 | 106 |
| Not completed | 45 | 44 |
Labour duration will be measured in minutes.
| minutes | Intervention | Control |
|---|---|---|
| Duration of the First Stage of Labour | 548.337 ± 62.7841 | 719.585 ± 86.5829 |
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.)
| Participants | Intervention | Control |
|---|---|---|
| participants reporting pain intensity as moderate | 26 | 9 |
| participants reporting pain intensity as severe | 57 | 62 |
| participants reporting pain intensity very severe | 12 | 35 |
used analgesics or did not use
| Participants | Intervention | Control |
|---|---|---|
| yes | 44 | 82 |
| no | 51 | 24 |
(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
| Participants | Intervention | Control |
|---|---|---|
| number of participants who gave birth normal | 95 | 97 |
| number of participants who gave birth by vacuum | 0 | 5 |
| number of participants who gave birth bycesarean | 0 | 4 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Satisfied | 89 | 9 |
| dissatisfied | 6 | 97 |
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
| Participants | Intervention | Control |
|---|---|---|
| Apgar score ≤ 3 | 2 | 13 |
| Apgar score 4-6 | 2 | 10 |
| Apgar score ≥7 | 91 | 83 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/95 (0%) | 0/95 (0%) | 0/95 (0%) |
| Control | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
| Age, Customized(participants) | Intervention | Control | Total |
|---|---|---|---|
| <20 | 10 | 19 | 29 |
| 20-29 | 66 | 79 | 145 |
| 30-39 | 19 | 8 | 27 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 95 | 106 | 201 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Education(Participants) | Intervention | Control | Total |
|---|---|---|---|
| illiterate | 1 | 21 | 22 |
| primary school | 11 | 19 | 30 |
| secondary school | 23 | 22 | 45 |
| Diploma | 16 | 22 | 38 |
| Bachelor | 44 | 22 | 66 |
| Employment(Participants) | Intervention | Control | Total |
|---|---|---|---|
| employed | 25 | 17 | 42 |
| not employed | 70 | 89 | 159 |
| Nationality(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Jordanian | 85 | 106 | 191 |
| non Jordanian | 10 | 0 | 10 |
| monthly Income (Jordanian Dinar)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| < 200 | 16 | 21 | 37 |
| 200-399 | 11 | 25 | 36 |
| 400-599 | 57 | 55 | 112 |
| 600 and more | 11 | 5 | 16 |
| Residence(Participants) | Intervention | Control | Total |
|---|---|---|---|
| city | 50 | 38 | 88 |
| village | 45 | 68 | 113 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2019, 11 months.
Results were first posted in Oct 2019, 7 months after primary completion.
Of 183 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 11 months is above that.
Counting every sponsor, half of 185 studies reached it within 9 months; a quarter within 5 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Mutah University