Deciding labor admission using transperineal ultrasound versus vaginal exam
Official title: Toma de Decisiones en la Admisión Hospitalaria al Parto Con Ecografía Transperineal vs. Tacto Vaginal: Estudio Aleatorizado Controlado
Run by Hospital Universitario La Paz · NCT07278271 · Data updated 2026-11-12
This trial will test whether using a transperineal ultrasound instead of a vaginal exam helps doctors decide whether to admit term pregnant women who arrive in labor.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 170 (estimated) |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | January 29, 2024 |
| Main results expected | January 2026 |
| Study ends | March 2026 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT07278271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–45 with a singleton, cephalic pregnancy at ≥37 weeks presenting with spontaneous contractions who can provide informed consent.
✕Probably not a fit
Patients with premature rupture of membranes, known high-risk conditions, prior cesarean, non-cephalic presentation, planned elective cesarean, or those requiring immediate obstetric intervention are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized controlled trial at Hospital Universitario La Paz will enroll term (≥37 weeks) pregnant women with spontaneous contractions and randomly assign them 1:1 to either a transperineal ultrasound-based admission protocol or standard vaginal examination. In the ultrasound arm, admission is recommended for cervical dilation ≥3 cm or an angle of progression >120° with regular contractions; in the vaginal exam arm, admission is recommended for cervical dilation ≥4 cm with regular contractions. Participants report discomfort during the admission exam on a 0–10 scale and all labor outcomes (induction, oxytocin use, time to delivery, and mode of delivery) are recorded. The trial aims to see if ultrasound guidance can reduce inductions and patient discomfort while improving admission decision consistency.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary hospital admissions and labor inductions and make admission exams less uncomfortable for birthing people.
How similar studies have gone: Smaller clinical and observational studies of intrapartum/transperineal ultrasound have shown promising improvements in objective assessment and patient comfort, but the technique is not yet universally adopted and larger trials are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Hospital Universitario La Paz
Madrid, Madrid, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.