Anthropometric Measurements on Size and Labour Outcomes

NCT ID: NCT07173452

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Pelvic Exam Pelvis Delivery Mode Midwife

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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the first group

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

Group Type EXPERIMENTAL

vaginal examination

Intervention Type OTHER

pelvic dimensions measured via vaginal examination.

physical body measurements

Intervention Type OTHER

Anthrometric measurements of the participants were made

the second group

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

Group Type EXPERIMENTAL

physical body measurements

Intervention Type OTHER

Anthrometric measurements of the participants were made

the third group

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

Group Type EXPERIMENTAL

physical body measurements

Intervention Type OTHER

Anthrometric measurements of the participants were made

transvaginal ultrasonographic

Intervention Type DIAGNOSTIC_TEST

intrapartum pelvic evaluations were performed by transvaginal ultrasonography

Interventions

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vaginal examination

pelvic dimensions measured via vaginal examination.

Intervention Type OTHER

physical body measurements

Anthrometric measurements of the participants were made

Intervention Type OTHER

transvaginal ultrasonographic

intrapartum pelvic evaluations were performed by transvaginal ultrasonography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Risky pregnancies,
* Planned caesarean sections
* Multiparous pregnant women
* History of pelvic trauma, disease, previous pelvic surgeries.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba YILMAZ ESENCAN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TUĞBA YILMAZ ESENCAN

Role: PRINCIPAL_INVESTIGATOR

TC Üsküdar Üniversitesi

Locations

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Uskudar Univercity

Istanbul, Ümraniye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21895610 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/21895610/

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

Other Identifiers

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2023/06

Identifier Type: -

Identifier Source: org_study_id

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