跳至主要内容
临床试验/NCT07278271
NCT07278271招募中不适用

Toma de Decisiones en la Admisión Hospitalaria al Parto Con Ecografía Transperineal vs. Tacto Vaginal: Estudio Aleatorizado Controlado

Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
1
主要终点
Rate of Labor Induction

研究概览

简要总结

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.

详细描述

This single-center, prospective, randomized controlled clinical trial is designed to evaluate whether transperineal ultrasound provides a more effective and less discomforting method than standard vaginal examination for decision-making regarding hospital admission in term pregnant women presenting with contractions. Vaginal examination remains the standard approach for assessing labor progression but is known to be subjective, poorly reproducible, and frequently uncomfortable for patients. In contrast, transperineal ultrasound offers objective and reproducible parameters such as cervical dilation, fetal head station, angle of progression, and head-perineum distance. Incorporating these measurements into the clinical evaluation may optimize admission criteria, reduce unnecessary hospitalizations, and lower the rate of labor inductions. After obtaining informed consent, eligible participants will be randomly assigned in a 1:1 ratio to either a transperineal ultrasound group or a standard vaginal examination group. In the ultrasound group, hospital admission will be recommended when cervical dilation is ≥3 cm or the angle of progression exceeds 120°, in the presence of regular uterine contractions. In the vaginal examination group, admission will be recommended when cervical dilation is ≥4 cm with regular contractions. Maternal discomfort during the evaluation will be assessed on a 0-10 numerical scale, and all labor outcomes and interventions will be recorded in standardized case report forms. A total of 170 participants (85 per group) will be enrolled to detect an 18% difference in labor induction rates with 80% power and a 95% confidence level. Statistical analyses will include descriptive and comparative methods (Chi-square, t-test, or non-parametric equivalents), with significance defined as p<0.05. The study will adhere to the principles of the Declaration of Helsinki and comply with applicable data protection regulations, including the Spanish Ley Orgánica de Protección de Datos (Organic Law on Data Protection, LOPD) and the European General Data Protection Regulation (GDPR).All participants will provide written informed consent prior to inclusion, and all data will be anonymized. The protocol has received approval from the institutional ethics committee. This trial builds upon prior observational findings demonstrating high agreement between ultrasound-based and traditional methods for assessing labor progression. By generating high-level evidence, it aims to support the implementation of transperineal ultrasound in labor triage protocols, improving the accuracy of clinical decision-making, enhancing maternal comfort, and contributing to better obstetric outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Rate of Labor Induction

时间窗: From hospital admission decision to delivery

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Javier Cuerva González

Attending Obstetrician and Principal Investigator

Hospital Universitario La Paz

研究点 (1)

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