NCT07278271 Decision-Making in Labor Admission Using Transperineal Ultrasound vs. Vaginal Examination
| NCT ID | NCT07278271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario La Paz |
| Condition | Labor Active Dilated Cm |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2024-01-29 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07278271 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Labor Active Dilated Cm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278271 currently recruiting?
Yes, NCT07278271 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Universitario La Paz to inquire about joining.
Where is the NCT07278271 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07278271 clinical trial?
NCT07278271 is sponsored by Hospital Universitario La Paz. The trial plans to enroll 170 participants.