Trial Outcomes & Findings for Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring (NCT NCT05863156)
NCT ID: NCT05863156
Last Updated: 2025-03-03
Results Overview
Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
before NST
Results posted on
2025-03-03
Participant Flow
December 2021 - January 2023
Randomization for the study was carried out on the website random.org; unique values were generated to divide 305 into 2 unique groups. The first group of 161 (81+81) numbers was randomly assigned to the intervention group, while the second group of 143 numbers was assigned to the control group.
Participant milestones
| Measure |
The Right Lateral Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
The Semi-Fowler Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Control Group: the Left Lateral Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
143
|
|
Overall Study
COMPLETED
|
60
|
60
|
120
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
23
|
Reasons for withdrawal
| Measure |
The Right Lateral Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
The Semi-Fowler Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Control Group: the Left Lateral Position
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
|---|---|---|---|
|
Overall Study
Failure to complete the electro-monitoring application in the appropriate position
|
21
|
21
|
23
|
Baseline Characteristics
Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
Baseline characteristics by cohort
| Measure |
Right Lateral Side-Lying Position
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Semi-Fowler Position
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Left Lateral Side-Lying Position
n=120 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
31.62 years
STANDARD_DEVIATION 4.43 • n=99 Participants
|
29.57 years
STANDARD_DEVIATION 3.93 • n=107 Participants
|
30.24 years
STANDARD_DEVIATION 4.64 • n=206 Participants
|
31.62 years
STANDARD_DEVIATION 4.46 • n=7 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Turkey
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
120 participants
n=206 Participants
|
240 participants
n=7 Participants
|
|
Body Mass Index
30 and over (obese)
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Body Mass Index
25-29 (overweight)
|
32 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Body Mass Index
19-24 (normal)
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Body Mass Index
18 and below (underweight)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: before NSTBlood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.
Outcome measures
| Measure |
Intervention 1
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Intervention 2
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Control Group
n=120 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
|---|---|---|---|
|
Right Side Lying Post NST (3)
|
113.67 mmHg
Standard Deviation 10.06
|
108.16 mmHg
Standard Deviation 10.56
|
112.80 mmHg
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: NST instantBlood Pressure (Systolic)
Outcome measures
| Measure |
Intervention 1
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Intervention 2
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Control Group
n=120 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
|---|---|---|---|
|
Right Side Lying
|
110.37 mmHg
Standard Deviation 9.41
|
107.00 mmHg
Standard Deviation 8.57
|
108.89 mmHg
Standard Deviation 11.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post NST (NST time:1 minute)Blood Pressure (Systolic)
Outcome measures
| Measure |
Intervention 1
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Intervention 2
n=60 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
Control Group
n=120 Participants
electro fetal monitoring
Right side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position: In the study, 120 participants in the left side lying position (control group).
|
|---|---|---|---|
|
Right Side Lying
|
115.91 mmHg
Standard Deviation 10.76
|
100.08 mmHg
Standard Deviation 8.15
|
113.56 mmHg
Standard Deviation 12.28
|
Adverse Events
Intervention 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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