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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHospital Universitario La Paz

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Premature rupture of membranes (PROM)

Multiple gestation

Known high-risk pregnancy (e.g., preeclampsia, intrauterine growth restriction, insulin-dependent diabetes)

Previous cesarean delivery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Transperineal UltrasoundExperimental treatment 1 intervention
Group B: Vaginal ExaminationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Labor Induction

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

Time frame
From hospital admission decision to delivery

Secondary outcomes

1

Use of Oxytocin for Labor Augmentation

Proportion of participants who receive oxytocin for augmentation of labor following initial triage evaluation.

Time frame
During labor (up to delivery)
2

Time from Admission to Delivery

Time frame
From hospital admission to time of delivery
3

Mode of Delivery (as recorded in the medical record)

Mode of delivery will be recorded from the medical record and categorized as spontaneous vaginal delivery, assisted vaginal delivery (instrumental), or cesarean section.

Time frame
At birth
4

Number of Vaginal Examinations Performed

Time frame
From hospital admission for labor to delivery

Other outcomes

Sponsors and contacts

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