Fetal Monitoring, Maternal Health, Patient Comfort
Conditions
Keywords
Fetal Monitoring, Patient Comfort, Maternal Health, Midwifery
Brief summary
The objective of this study was to assess the effects of different maternal positions during electronic fetal monitoring (EFM) on maternal and fetal health outcomes. The study was conducted between December 2021 and January 2023 in a maternity hospital in Istanbul, employing a randomized controlled trial design. A total of 240 pregnant women were randomized into three groups: 60 participants were assigned to the right-side lying position (intervention 1), 60 to the semi-sitting position (intervention 2), and 120 to the left-side lying. Maternal systolic blood pressure, body temperature, and pulse rate were measured before, during, and after the EFM procedure. Research data were collected through the Information Form and the General Comfort Scale-Short Form.
Detailed description
IIntroduction: Electronic fetal monitoring (EFM) is widely utilized for pregnancy and labor management due to its non-invasive nature, ease of use, and accessibility. However, the accuracy of EFM outcomes may be influenced by various factors, including the maternal position during monitoring, maternal comfort, and maternal blood pressure. This study aimed to explore how different positions during EFM influence both maternal. Objective: The primary objective of this study was to examine the effects of three different maternal positions during EFM-right-side lying, semi-sitting, and left-side lying-on maternal and fetal health parameters. These parameters included systolic blood pressure, body temperature, pulse rate, and maternal comfort. Methods: A randomized controlled trial was conducted in a pregnancy follow-up outpatient clinic at a maternity hospital in Istanbul from December 2021 to January 2023. The study included 240 pregnant women, who were randomly assigned to one of three groups: * Intervention 1 (right-side lying position) - 60 participants * Intervention 2 (semi-sitting position) - 60 participants * Control group (left-side lying position) - 120 participants Maternal physiological data were collected at three time points: pre-EFM, during EFM, and post-EFM. The General Comfort Scale-Short Form was used to assess maternal comfort. Statistical analyses were conducted to identify significant differences between groups and over time.
Interventions
DIAGNOSTIC_TESTRight side lying position
In the study, 60 participants were placed in the right side lying position (intervention 1)
DIAGNOSTIC_TESTSemi Fowler
In the study, 60 participants in the semi-sitting position (intervention 2)
DIAGNOSTIC_TESTleft side lying position
In the study, 120 participants in the left side lying position (control group).
Sponsors
Uskudar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
The study was conducted in a pregnant follow-up outpatient clinic of a maternity hospital in Istanbul, between December 2021 and January 2023, in a randomized controlled experimental study design with two interventions and a control group. In the study, 60 participants were placed in the right side lying position (intervention 1), 60 participants in the semi-sitting position (intervention 2) and 120 participants in the left side lying position (control group), and the study was completed with a total of 240 pregnant women. Research data were collected through the Information Form and the General Comfort Scale-Short Form.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Being over the age of 18, * Being 35 years of age and under, * Being a single fetus in the late 3rd trimester (34th-40th gestational week), * Fetal biometric measurements between 34-40 weeks of gestation, * No maternal and fetal risk affecting pregnancy, * It was determined that the vital signs were within normal values before the application, not being hungry during the application (at the latest 2 hours of fasting time will be checked), and accepting the recommended application position.
Exclusion criteria
\- The pregnant woman does not accept the recommended application position.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Right Side Lying Post NST (3) | before NST | Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right Side Lying | NST instant | Blood Pressure (Systolic) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Right Side Lying | post NST (NST time:1 minute) | Blood Pressure (Systolic) |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
December 2021 - January 2023
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Right Lateral Side-Lying 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). | 60 |
| 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). | 60 |
| Left Lateral Side-Lying 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). | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Failure to complete the electro-monitoring application in the appropriate position | 21 | 21 | 23 |
Baseline characteristics
| Characteristic | Right Lateral Side-Lying Position | Semi-Fowler Position | Left Lateral Side-Lying Position | Total |
|---|---|---|---|---|
| Age, Categorical Age <=18 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Age >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age Between 18 and 65 years | 60 Participants | 60 Participants | 118 Participants | 238 Participants |
| Age, Continuous | 31.62 years STANDARD_DEVIATION 4.43 | 29.57 years STANDARD_DEVIATION 3.93 | 30.24 years STANDARD_DEVIATION 4.64 | 31.62 years STANDARD_DEVIATION 4.46 |
| Body Mass Index 18 and below (underweight) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index 19-24 (normal) | 16 Participants | 20 Participants | 31 Participants | 67 Participants |
| Body Mass Index 25-29 (overweight) | 32 Participants | 28 Participants | 61 Participants | 121 Participants |
| Body Mass Index 30 and over (obese) | 12 Participants | 12 Participants | 28 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 60 Participants | 60 Participants | 120 Participants | 240 Participants |
| Region of Enrollment Turkey | 60 participants | 60 participants | 120 participants | 240 participants |
| Sex: Female, Male Female | 60 Participants | 60 Participants | 120 Participants | 240 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 120 |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 120 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 120 |
Outcome results
Primary
Right Side Lying Post NST (3)
Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.
Time frame: before NST
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Intervention 1 | Right Side Lying Post NST (3) | 113.67 mmHg | Standard Deviation 10.06 |
| Intervention 2 | Right Side Lying Post NST (3) | 108.16 mmHg | Standard Deviation 10.56 |
| Control Group | Right Side Lying Post NST (3) | 112.80 mmHg | Standard Deviation 11.21 |
Secondary
Right Side Lying
Blood Pressure (Systolic)
Time frame: NST instant
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Intervention 1 | Right Side Lying | 110.37 mmHg | Standard Deviation 9.41 |
| Intervention 2 | Right Side Lying | 107.00 mmHg | Standard Deviation 8.57 |
| Control Group | Right Side Lying | 108.89 mmHg | Standard Deviation 11 |
Other Pre-specified
Right Side Lying
Blood Pressure (Systolic)
Time frame: post NST (NST time:1 minute)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Intervention 1 | Right Side Lying | 115.91 mmHg | Standard Deviation 10.76 |
| Intervention 2 | Right Side Lying | 100.08 mmHg | Standard Deviation 8.15 |
| Control Group | Right Side Lying | 113.56 mmHg | Standard Deviation 12.28 |