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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Transperineal Ultrasound
Diagnostic testTransperineal 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 testStandard digital vaginal examination will be conducted to assess cervical dilatation. Admission decisions will follow institutional protocol (≥4 cm dilation with regular contractions).
Treatment groups
Trial outcomes
Primary outcomes
Rate of Labor Induction
Proportion of participants who undergo labor induction if admitted after evaluation by transperineal ultrasound or vaginal examination.
Secondary outcomes
Use of Oxytocin for Labor Augmentation
Proportion of participants who receive oxytocin for augmentation of labor following initial triage evaluation.
Time from Admission to Delivery
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.
Number of Vaginal Examinations Performed
Sponsors and contacts
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