Anthropometric Measurements on Size and Labour Outcomes

NCT07173452 | Completed DMC

• 1 other identifier: 2023/06
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Exam; Pelvis; Delivery Mode; Midwife

Keywords

Physical Body Measurements; External Pelvis Measurements; Labor Pain; Duration of Labor; Mode of Delivery; Midwife

Outcome Measures

Primary Outcomes (3)

• vaginal examination

  Pelvic dimensions were evaluated by vaginal examination.

  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.

• physical body measurements

  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.

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

• transvaginal USG

  transvaginal ultrasonographic measurements

  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

Study Arms (3)

the first group

EXPERIMENTAL

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

Other: vaginal examination; Other: physical body measurements

the second group

EXPERIMENTAL

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

Other: physical body measurements

the third group

EXPERIMENTAL

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

Other: physical body measurements; Diagnostic Test: transvaginal ultrasonographic

Interventions

vaginal examination OTHER

pelvic dimensions measured via vaginal examination.

the first group

physical body measurements OTHER

Anthrometric measurements of the participants were made

the first group; the second group; the third group

transvaginal ultrasonographic DIAGNOSTIC_TEST

intrapartum pelvic evaluations were performed by transvaginal ultrasonography

the third group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Women who gave birth constitute the sample of the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Uskudar Univercity

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Benjamin SJ, Daniel AB, Kamath A, Ramkumar V. Anthropometric measurements as predictors of cephalopelvic disproportion: Can the diagnostic accuracy be improved? Acta Obstet Gynecol Scand. 2012 Jan;91(1):122-127. doi: 10.1111/j.1600-0412.2011.01267.x. Epub 2011 Oct 13.

  PMID: 21895610 BACKGROUND

Related Links

• Anthropometric measurements as predictors of cephalopelvic disproportion: Can the diagnostic accuracy be improved?

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• TUĞBA YILMAZ ESENCAN

  TC Üsküdar Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This cross-sectional study was conducted between December 2022 and June 2023 in the labour ward of a maternity hospital in Istanbul and involved 153 pregnant women. The participants were evenly divided into three observational groups (arms), each consisting of 51 individuals, based on the method used to assess pelvic measurements. In the first group (Vaginal Examination Group), participants underwent pelvic assessment through standard vaginal examination techniques alongside physical body measurements. In the second group (External Pelvic Measurement Group), participants received external pelvic measurements using a pelvimeter in addition to physical body measurements. In the third group (Transvaginal Ultrasonographic Group), pelvic dimensions were evaluated via transvaginal ultrasonography along with physical body measurements. Each diagnostic approach served as the defining intervention for its respective group. Data were collected through face-to-face interviews and direct physical

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: September 15, 2025
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)