Trial Outcomes & Findings for Effects of Ambulation During First Stage of Labour on Maternal and Neonatal Outcomes (NCT NCT03447015)
NCT ID: NCT03447015
Last Updated: 2024-12-06
Results Overview
Labour duration will be measured in minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
from 3-4 cm of cervical dilatation until delivery of the child.
Results posted on
2024-12-06
Participant Flow
Participant milestones
| Measure |
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).
|
Control
women will receive usual maternity care.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
150
|
|
Overall Study
COMPLETED
|
95
|
106
|
|
Overall Study
NOT COMPLETED
|
45
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20
|
10 participants
n=95 Participants
|
19 participants
n=106 Participants
|
29 participants
n=201 Participants
|
|
Age, Customized
20-29
|
66 participants
n=95 Participants
|
79 participants
n=106 Participants
|
145 participants
n=201 Participants
|
|
Age, Customized
30-39
|
19 participants
n=95 Participants
|
8 participants
n=106 Participants
|
27 participants
n=201 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=95 Participants
|
106 Participants
n=106 Participants
|
201 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=95 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=201 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Education
illiterate
|
1 Participants
n=95 Participants
|
21 Participants
n=106 Participants
|
22 Participants
n=201 Participants
|
|
Education
primary school
|
11 Participants
n=95 Participants
|
19 Participants
n=106 Participants
|
30 Participants
n=201 Participants
|
|
Education
secondary school
|
23 Participants
n=95 Participants
|
22 Participants
n=106 Participants
|
45 Participants
n=201 Participants
|
|
Education
Diploma
|
16 Participants
n=95 Participants
|
22 Participants
n=106 Participants
|
38 Participants
n=201 Participants
|
|
Education
Bachelor
|
44 Participants
n=95 Participants
|
22 Participants
n=106 Participants
|
66 Participants
n=201 Participants
|
|
Employment
employed
|
25 Participants
n=95 Participants
|
17 Participants
n=106 Participants
|
42 Participants
n=201 Participants
|
|
Employment
not employed
|
70 Participants
n=95 Participants
|
89 Participants
n=106 Participants
|
159 Participants
n=201 Participants
|
|
Nationality
Jordanian
|
85 Participants
n=95 Participants
|
106 Participants
n=106 Participants
|
191 Participants
n=201 Participants
|
|
Nationality
non Jordanian
|
10 Participants
n=95 Participants
|
0 Participants
n=106 Participants
|
10 Participants
n=201 Participants
|
|
monthly Income (Jordanian Dinar)
< 200
|
16 Participants
n=95 Participants
|
21 Participants
n=106 Participants
|
37 Participants
n=201 Participants
|
|
monthly Income (Jordanian Dinar)
200-399
|
11 Participants
n=95 Participants
|
25 Participants
n=106 Participants
|
36 Participants
n=201 Participants
|
|
monthly Income (Jordanian Dinar)
400-599
|
57 Participants
n=95 Participants
|
55 Participants
n=106 Participants
|
112 Participants
n=201 Participants
|
|
monthly Income (Jordanian Dinar)
600 and more
|
11 Participants
n=95 Participants
|
5 Participants
n=106 Participants
|
16 Participants
n=201 Participants
|
|
Residence
city
|
50 Participants
n=95 Participants
|
38 Participants
n=106 Participants
|
88 Participants
n=201 Participants
|
|
Residence
village
|
45 Participants
n=95 Participants
|
68 Participants
n=106 Participants
|
113 Participants
n=201 Participants
|
|
Health insurance
yes
|
54 Participants
n=95 Participants
|
55 Participants
n=106 Participants
|
109 Participants
n=201 Participants
|
|
Health insurance
No
|
41 Participants
n=95 Participants
|
51 Participants
n=106 Participants
|
92 Participants
n=201 Participants
|
PRIMARY outcome
Timeframe: from 3-4 cm of cervical dilatation until delivery of the child.Labour duration will be measured in minutes.
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Duration of the First Stage of Labour
|
548.337 minutes
Standard Deviation 62.7841
|
719.585 minutes
Standard Deviation 86.5829
|
PRIMARY outcome
Timeframe: from 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.)
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Labour Pain Intensity
participants reporting pain intensity as moderate
|
26 Participants
|
9 Participants
|
|
Labour Pain Intensity
participants reporting pain intensity as severe
|
57 Participants
|
62 Participants
|
|
Labour Pain Intensity
participants reporting pain intensity very severe
|
12 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 24 to 48 hours after birth.used analgesics or did not use
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Use of Analgesics
no
|
51 Participants
|
24 Participants
|
|
Use of Analgesics
yes
|
44 Participants
|
82 Participants
|
PRIMARY outcome
Timeframe: assessed up to child delivery(defined as normal, vacuum extraction, forceps delivery, or cesarean section)
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Mode of Birth
number of participants who gave birth normal
|
95 Participants
|
97 Participants
|
|
Mode of Birth
number of participants who gave birth by vacuum
|
0 Participants
|
5 Participants
|
|
Mode of Birth
number of participants who gave birth bycesarean
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 24 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.
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Woman's Satisfaction With the Birth Experience
Satisfied
|
89 Participants
|
9 Participants
|
|
Woman's Satisfaction With the Birth Experience
dissatisfied
|
6 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: at 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
Outcome measures
| Measure |
Intervention
n=95 Participants
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).
|
Control
n=106 Participants
women will receive usual maternity care.
|
|---|---|---|
|
Newborn Health Status
Apgar score ≤ 3
|
2 Participants
|
13 Participants
|
|
Newborn Health Status
Apgar score 4-6
|
2 Participants
|
10 Participants
|
|
Newborn Health Status
Apgar score ≥7
|
91 Participants
|
83 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place