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临床试验/NCT07173452
NCT07173452已完成不适用

The Effect of Women's Anthropometric Measurements on Pelvic Size and Labour Outcomes

Uskudar University2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
vaginal examination

研究概览

简要总结

This study aims to evaluate women's physical body measurements and externally measurable pelvis measurements and determine their impact on labor pain level, duration of labor, and mode of delivery. The study was conducted between December 2022 and June 2023 at the Zeynep Kamil Women and Children's Health Education and Research Hospital in Istanbul, Turkey. The sample size was calculated using the OpenEpi program with a confidence interval of 80% and a sampling error of 0.05, resulting in a sample size of 139 individuals. Anticipating potential loss to follow-up during the study, the sample size was increased by 10% to 153 individuals. This sample group was divided into three equal groups, and pelvis measurement evaluations were recorded. Each group included 51 pregnant women. Data were collected through face-to-face measurements conducted by researchers using various forms, including an introductory information form, physical examination measurement form, transvaginal ultrasound measurement form, birth evaluation form, postpartum and neonatal evaluation form, visual analog pain scale (VAS) form, external pelvis measurement form and vaginal examination with pelvis measurement form.

详细描述

Background: One of the most critical factors in the progression of labour is the compatibility between the fetal head and the maternal pelvis. Therefore, the assessment of the pelvis during childbirth is of great importance.

Objectives: This study aims to evaluate women's physical body measurements in relation to externally measurable pelvic dimensions, to examine the relationship between them, and to determine their impact on pain levels during labour, the duration of labour, and the mode of delivery.

Methods: This cross-sectional study was conducted between December 2022 and June 2023 in the labour ward of a maternity hospital in Istanbul, involving 153 pregnant women. The sample was evenly divided into three groups, with 51 participants in each, and pelvic measurement assessments were recorded accordingly. In the first group, participants' physical body measurements were evaluated alongside pelvic dimensions measured via vaginal examination. In the second group, physical measurements were assessed together with external pelvic measurements. In the third group, physical body measurements were evaluated in conjunction with pelvic assessments obtained through transvaginal ultrasonographic measurements. The results obtained from the three groups were compared with one another. Data were collected through face-to-face interviews and direct measurements performed by the researchers using the following instruments: a descriptive information form, physical examination measurement form, transvaginal ultrasonography measurement form, labour assessment form, postpartum and neonatal evaluation form, visual analogue scale for pain, external pelvic measurement form, and vaginal pelvic examination form.

Keywords: Physical Body Measurements, External Pelvic Measurements, Labour Pain, Duration of Labour, Mode of Delivery, Midwife

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Primiparous,
  • •The onset of labour,
  • •Being between 37-42 weeks of gestation,
  • •To be able to speak and understand Turkish,
  • •18 years of age or older,
  • •No history of a disease affecting bone anatomy

排除标准

  • •Risky pregnancies,
  • •Planned caesarean sections
  • •Multiparous pregnant women
  • •History of pelvic trauma, disease, previous pelvic surgeries.

研究组 & 干预措施

the first group

Experimental

In the first group, participants' physical body measurements were evaluated alongside pelvic dimensions measured via vaginal examination.

干预措施: vaginal examination (Other)

the first group

Experimental

In the first group, participants' physical body measurements were evaluated alongside pelvic dimensions measured via vaginal examination.

干预措施: physical body measurements (Other)

the second group

Experimental

In the second group, physical measurements were assessed together with external pelvic measurements.

干预措施: physical body measurements (Other)

the third group

Experimental

In the third group, physical body measurements were evaluated in conjunction with pelvic assessments obtained through transvaginal ultrasonographic measurements.

干预措施: physical body measurements (Other)

the third group

Experimental

In the third group, physical body measurements were evaluated in conjunction with pelvic assessments obtained through transvaginal ultrasonographic measurements.

干预措施: transvaginal ultrasonographic (Diagnostic Test)

结局指标

主要结局

vaginal examination

时间窗: Measurements will be taken during the active phase of labor, when cervical dilation is between 4-10 cm (typically 6-12 hours prior to delivery), using a manual vaginal examination performed by an experienced obstetrician.

Pelvic dimensions were evaluated by vaginal examination.

physical body measurements

时间窗: Within the first 6 hours after the onset of active labor (defined as cervical dilation ≥4 cm).

Maternal anthropometric parameters, including body weight (kg), height (cm), and Body Mass Index (BMI, kg/m²), will be assessed using standardized tools. Weight will be measured using a calibrated digital scale, and height using a calibrated stadiometer. BMI will be calculated using the formula: BMI = weight (kg) / \[height (m)\]².The weight and height will be combined to report BMI in kg/m\^2.

transvaginal USG

时间窗: Transvaginal ultrasonographic measurements will be performed within the first 2 hours after the onset of active labor, defined as cervical dilation ≥ 4 cm. These measurements will include fetal head position, angle of progression (in degrees), and head-p

transvaginal ultrasonographic measurements

vaginal examination

时间窗: Measurements will be taken during the active phase of labor, when cervical dilation is between 4-10 cm (typically 6-12 hours prior to delivery), using a manual vaginal examination performed by an experienced obstetrician.

Pelvic dimensions were evaluated by vaginal examination.

physical body measurements

时间窗: Within the first 6 hours after the onset of active labor (defined as cervical dilation ≥4 cm).

Maternal anthropometric parameters, including body weight (kg), height (cm), and Body Mass Index (BMI, kg/m²), will be assessed using standardized tools. Weight will be measured using a calibrated digital scale, and height using a calibrated stadiometer. BMI will be calculated using the formula: BMI = weight (kg) / \[height (m)\]².The weight and height will be combined to report BMI in kg/m\^2.

transvaginal USG

时间窗: Transvaginal ultrasonographic measurements will be performed within the first 2 hours after the onset of active labor, defined as cervical dilation ≥ 4 cm. These measurements will include fetal head position, angle of progression (in degrees), and head-p

transvaginal ultrasonographic measurements

次要结局

未报告次要终点

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba YILMAZ ESENCAN

Assistant Professor

Uskudar University

研究点 (2)

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