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Decision-Making in Labor Admission Using Transperineal Ultrasound vs. Vaginal Examination

NCT07278271 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-12-12

No results posted yet for this study

Summary

This clinical trial aims to determine whether transperineal ultrasound (a perineal external scan) can improve decision-making for hospital admission in term pregnant women in labor compared to traditional vaginal examination. Term pregnant women (\>37 weeks) presenting with contractions at the emergency department will be randomly assigned to undergo either a transperineal ultrasound or a vaginal examination upon arrival. The study will evaluate whether ultrasound-based assessment reduces the rate of labor inductions and decreases patient discomfort during the admission evaluation. All participants will receive standard clinical evaluation and follow-up according to the assigned method, report discomfort levels using a standardized scale, and have labor outcomes recorded - including induction, oxytocin use, time to delivery, and mode of delivery -, to determine whether ultrasound improves clinical decision-making and maternal comfort.

Conditions

  • Labor Active Dilated Cm

Interventions

DIAGNOSTIC_TEST

Transperineal Ultrasound

Transperineal ultrasound will be performed to assess cervical dilatation, angle of progression, fetal head position, and head-perineum distance. Admission decisions will be made based on predefined sonographic thresholds.

DIAGNOSTIC_TEST

Vaginal Examination

Standard digital vaginal examination will be conducted to assess cervical dilatation. Admission decisions will follow institutional protocol (≥4 cm dilation with regular contractions).

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278271 on ClinicalTrials.gov