Pelvic ExamPelvisNCT07173452
Anthropometric Measurements on Size and Labour Outcomes
A study testing vaginal examination, physical body measurements and transvaginal ultrasonographic in people with Pelvic Exam and Pelvis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Exam, Pelvis, Delivery Mode
- What is being tested?
- vaginal examination, physical body measurements and transvaginal ultrasonographic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Risky pregnancies,
- Planned caesarean sections
- Multiparous pregnant women
- History of pelvic trauma, disease, previous pelvic surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Women's Anthropometric Measurements on Pelvic Size and Labour Outcomes
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.
Read the detailed description
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
- Pelvic Exam, Pelvis, Delivery Mode, Midwife
- Being tested
- vaginal examination, physical body measurements, transvaginal ultrasonographic
- Keywords
- Physical Body Measurements, External Pelvis Measurements, Labor Pain, Duration of Labor, Mode of Delivery, Midwife
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal examinationOther
pelvic dimensions measured via vaginal examination.
physical body measurementsOther
Anthrometric measurements of the participants were made
transvaginal ultrasonographicDiagnostic test
intrapartum pelvic evaluations were performed by transvaginal ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| the first group | Experimental | In the first group, participants' physical body measurements were evaluated alongside pelvic dimensions measured via vaginal examination. Receives: Other: vaginal examination; Other: physical body measurements |
| the second group | Experimental | In the second group, physical measurements were assessed together with external pelvic measurements. Receives: 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. Receives: Other: physical body measurements; Diagnostic Test: transvaginal ultrasonographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal examination
Pelvic dimensions were evaluated by vaginal examination.
Measured: 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.
Measured: Within the first 6 hours after the onset of active labor (defined as cervical dilation ≥4 cm).
transvaginal USG
transvaginal ultrasonographic measurements
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Dec 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic ExamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
- Investigators
- TUĞBA YILMAZ ESENCAN, Principal investigator, TC Üsküdar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173452
- Sponsor's protocol ID
- 2023/06
- Acronym
- Pelvis
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: starting in January 2026
Publications
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.
PubMed 21895610
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Women's Anthropometric Measurements on Pelvic Size and Labour Outcomes
- ClinicalTrials.gov ID
- NCT07173452
- Acronym / sponsor ID
- Pelvis / 2023/06
- Conditions
- Pelvic Exam, Pelvis, Delivery Mode, Midwife
- Keywords
- Physical Body Measurements, External Pelvis Measurements, Labor Pain, Duration of Labor, Mode of Delivery, Midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| the first group | Experimental | Other: vaginal examination, Other: physical body measurementsIn the first group, participants' physical body measurements were evaluated alongside pelvic dimensions measured via vaginal examination. |
| the second group | Experimental | Other: physical body measurementsIn the second group, physical measurements were assessed together with external pelvic measurements. |
| the third group | Experimental | Other: physical body measurements, Diagnostic Test: transvaginal ultrasonographicIn the third group, physical body measurements were evaluated in conjunction with pelvic assessments obtained through transvaginal ultrasonographic measurements. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- Risky pregnancies,
- Planned caesarean sections
- Multiparous pregnant women
- History of pelvic trauma, disease, previous pelvic surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal examinationpelvic dimensions measured via vaginal examination. | Other | the first group |
| physical body measurementsAnthrometric measurements of the participants were made | Other | the first group, the second group, the third group |
| transvaginal ultrasonographicintrapartum pelvic evaluations were performed by transvaginal ultrasonography | Diagnostic test | the third group |
Primary outcome
vaginal examination
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 21895610Benjamin 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.
- Anthropometric measurements as predictors of cephalopelvic disproportion: Can the diagnostic accuracy be improved?Link provided by the sponsor.
- Individual participant dataSharing planned: No. starting in January 2026
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Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUĞBA YILMAZ ESENCAN principal investigator
TC Üsküdar Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal examination, physical body measurements and transvaginal ultrasonographic in people with Pelvic Exam and Pelvis, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal examination (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.