Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

Официальное название

Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial

Обзор

The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally. Specifically, it aims to answer the questions: * In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery? * Does changing the patient's position in active labor affect the position of the baby at the time of delivery? * Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience? Participants will: * Receive an ultrasound during labor to determine the position of their baby * Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group * Receive additional ultrasounds during labor to assess their baby's position * Fill out a questionnaire about their labor experience following the delivery of their baby

Подробное описание

In this randomized trial, the investigators aim to evaluate the effects of early ultrasound diagnosis and active management of fetal malposition during the first stage of labor. Specifically, the investigators will compare the modified Sims (side-lying) position ipsilateral to fetal spine with the addition of a peanut ball versus free maternal position choice in occiput posterior (OP) or occiput transverse (OT) fetuses diagnosed by ultrasound during active labor, defined as greater than 6cm cervical dilation. The primary outcome will be operative delivery rates, defined as either cesarean delivery or instrumental vaginal delivery with vacuum or forceps. The investigators will also assess rates of spontaneous rotation to occiput anterior (OA) position at complete dilation and at delivery, as well as the impact of the position changes on the patient's labor experience and their perceived autonomy.

Вмешательства

• Поведенческое Maternal position change to side-lying lateral with peanut ball
  Participants will be assisted into a position lying on their side, specifically the same side as the fetal spine diagnosed by ultrasound. An inflated peanut ball will be positioned between the legs to open the pelvis. They will be asked to maintain the position for 60 minutes.
• Поведенческое Free maternal position
  Participants will be asked to adopt any position of their choosing and to maintain it for 60 minutes. They will be asked to not use a peanut ball during the 60 minute study period.

Первичные конечные точки

• Operative Delivery Rate [Срок оценки: Enrollment in active labor through delivery, on average 12 hours]

Вторичные конечные точки (8)

• Rotation at Complete Dilation [Срок оценки: Enrollment in active labor through delivery, on average 12 hours]
• Rotation at Delivery [Срок оценки: Enrollment in active labor through delivery, on average 12 hours]
• Duration of Active Second Stage [Срок оценки: Onset of second stage of labor to delivery, up to 4 hours]
• Estimated Blood Loss [Срок оценки: Time of delivery to 24 hours postpartum]
• Degree of Laceration following Delivery [Срок оценки: Time of delivery to admission to postpartum unit, on average 2 hours]
• Score on Labor Agentry Scale [Срок оценки: Time of delivery to discharge from hospital, on average 2 days]
• Apgar Scores [Срок оценки: Time of delivery to 5 minutes postpartum]
• Neonatal Intensive Care Unit (NICU) Admission [Срок оценки: Time of delivery to up to 6 weeks postpartum]

Критерии участия

Критерии включения

• Maternal age >18
• Term gestation (>37 weeks)
• Singleton pregnancy
• Spontaneous or induced active labor (cervical dilation 6-9cm)
• Epidural anesthesia
• Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound
• Continuous external fetal monitoring
• Ability to consent

Критерии исключения

• Multiple gestations
• Unanesthetized labor
• Known fetal anomalies
• Known intrauterine fetal demise
• Inability to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Women and Infant's Hospital of Rhode Island — Providence

Идентификаторы

NCT: NCT05881629 · 2015598-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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