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

NCT07278271 | Recruiting

• 1 other identifier: PI-4053
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transperineal ultrasound; Intrapartum ultrasound; Vaginal examination; Hospital admission in labor; Term pregnancy; Angle of progression; Cervical dilatation; Ultrasound vs vaginal exam

Outcome Measures

Primary Outcomes (1)

• Rate of Labor Induction

  Proportion of participants who undergo labor induction if admitted after evaluation by transperineal ultrasound or vaginal examination.

  From hospital admission decision to delivery

Secondary Outcomes (4)

• Use of Oxytocin for Labor Augmentation

  During labor (up to delivery)

• Time from Admission to Delivery

  From hospital admission to time of delivery

• Mode of Delivery (as recorded in the medical record)

  At birth

• Number of Vaginal Examinations Performed

  From hospital admission for labor to delivery

Study Arms (2)

Transperineal Ultrasound

EXPERIMENTAL

Participants in this arm will undergo transperineal ultrasound to assess cervical dilatation, angle of progression (AOP), fetal head position, and head-perineum distance (HPD). Hospital admission will be based on predefined sonographic criteria (e.g., dilation ≥3 cm or angle of progression \>120° plus regular uterine contractions).

Diagnostic Test: Transperineal Ultrasound

Vaginal Examination

ACTIVE COMPARATOR

Participants in this arm will undergo standard digital vaginal examination. Hospital admission will be based on cervical dilation ≥4 cm and regular uterine contractions, following the routine clinical protocol.

Diagnostic Test: Vaginal Examination

Interventions

Transperineal Ultrasound DIAGNOSTIC_TEST

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.

Transperineal Ultrasound

Vaginal Examination DIAGNOSTIC_TEST

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

Vaginal Examination

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility to participate in this study is based on biological sex, as only individuals who are biologically female can become pregnant and experience labor.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 45 years
• Singleton pregnancy
• Gestational age ≥ 37 weeks (term pregnancy)
• Spontaneous uterine contractions at the time of presentation to the emergency department
• Cephalic presentation
• Willingness and ability to provide written informed consent

You may not qualify if:

• Premature rupture of membranes (PROM)
• Multiple gestation
• Known high-risk pregnancy (e.g., preeclampsia, intrauterine growth restriction, insulin-dependent diabetes)
• Previous cesarean delivery
• Breech or other non-cephalic presentation
• Elective cesarean section planned or requested
• Refusal to undergo vaginal delivery
• Inability or unwillingness to comply with the study protocol

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (1)

• Cuerva MJ, Garcia-Casarrubios P, Garcia-Calvo L, Gutierrez-Simon M, Ordas P, Magdaleno F, Bartha JL; ITU-R12 Group. Use of intrapartum ultrasound in term pregnant women with contractions before hospital admission. Acta Obstet Gynecol Scand. 2019 Feb;98(2):162-166. doi: 10.1111/aogs.13474. Epub 2018 Oct 30.

  PMID: 30288731 BACKGROUND

MeSH Terms

Interventions

Gynecological Examination

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Obstetrician and Principal Investigator

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: December 12, 2025
• Study Start: January 29, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)