Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT07278271

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

Led by Hospital Universitario La Paz · Updated on 2025-12-12

170

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years
  • Singleton pregnancy
  • Gestational age of 37 weeks or more (term pregnancy)
  • Spontaneous uterine contractions at presentation to the emergency department
  • Baby positioned head-down (cephalic presentation)
  • Willingness and ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Premature rupture of membranes (PROM)
  • Multiple gestation (twins or more)
  • Known high-risk pregnancy such as preeclampsia, intrauterine growth restriction, or insulin-dependent diabetes
  • Previous cesarean delivery
  • Breech or other non-cephalic baby position
  • Planned or requested elective cesarean section
  • Refusal to undergo vaginal delivery
  • Inability or unwillingness to follow the study protocol

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario La Paz

Madrid, Madrid, Spain, 28046

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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