Clinical trial NCT05863156: Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
Official title: Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring on Maternal Comfort, Maternal Blood Pressure and Fetal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Patient Comfort
Maternal Health
Keywords: Fetal Monitoring
Patient Comfort
Maternal Health
Midwifery
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 305
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Right Side Lying Post NST (3)
timeFrame: before NST
Secondary outcomes:
measure: Right Side Lying
timeFrame: NST instant
Other outcomes:
measure: Right Side Lying
timeFrame: post NST (NST time:1 minute)
Locations:
city: İstanbul
country: Turkey
facility: Uskudar Univercity
state: Ümraniye
Study officials:
affiliation: Uskudar University
name: TUĞBA YILMAZ ESENCAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humphries A, Mirjalili SA, Tarr GP, Thompson JMD, Stone P. The effect of supine positioning on maternal hemodynamics during late pregnancy. J Matern Fetal Neonatal Med. 2019 Dec;32(23):3923-3930. doi: 10.1080/14767058.2018.1478958. Epub 2018 Jun 3.