Intrapartum Ultrasound for Assessment of Fetal Progression

Официальное название

Intrapartum Ultrasound for Assessment of Fetal Progression: a Multicentre Randomized Within-Subject Trial Evaluating Variation in AoP and HPD According to Maternal Position and Pelvic Mobility (MaPP Study)

Обзор

The use of ultrasound has been suggested to support the management of labour. According to several studies, ultrasound examination is more accurate and reproducible than clinical examination in diagnosing fetal head position, fetal station, and the prediction of labour arrest. Furthermore, there is growing evidence that ultrasound in labour may predict the outcome of instrumental vaginal delivery: a support to assess when an operative delivery is necessary. Ultrasound in labour can be performed using a transabdominal approach, mainly to determine head and spine position, or a transperineal approach, to assess head station and the situation at low stations. Several sonographic parameters have been proposed to evaluate the head station. Furthermore, all ultrasound parameters studied so far, have always been measured with the woman in a supine position. While the biomechanics of childbirth with its mechanisms (known as nutation, counter-nutation of the pelvis, and the coccyx retropulsion) together with maternal movement, promote fetal rotation and the adaptation of its diameters with those of the maternal pelvis, allowing to gain more room for the fetal descent. Moreover, in most of the studies on intrapartum ultrasound, the mobility of the pelvis has not been mentioned. The contracted pelvis is the absence of mobility that leads to fetal-pelvic disproportion, arrest of labour, and operative delivery. Maternal pelvis biomechanics studies by high technological techniques have shown that maternal shifting positions during pregnancy and childbirth can create more room in the pelvis for safe delivery. The external and internal pelvic diameters are closely related. For this reason, the evaluation of the mobility of the pelvis appears to be a necessary element to understand the ability of that pelvis to widen its diameters for fetal descent. The aim of the study is to measure the variation of AoP, HPD in the supine position and in kneeling-squat position in the same woman and the cut-offs of the new ultrasound parameters and predictive capacity for vaginal birth.

Вмешательства

• Другое Transperineal imaging
  To measure the difference between ultrasound parameters based on maternal position: to measure the variation of Angle of progression (AoP), ), HPD(head perineum distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the expulsion phase, in the resting step and during the push.

Первичные конечные точки

• Ultrasound AoP EP [Срок оценки: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.]
• Ultrasound AoP RS [Срок оценки: During the resting step]
• Ultrasound AoP P [Срок оценки: During the push]
• Ultrasound HPD EP [Срок оценки: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.]
• Ultrasound HPD RS [Срок оценки: During the resting step]
• Ultrasound HPD P [Срок оценки: During the push]

Вторичные конечные точки (9)

• mode of delivery [Срок оценки: during delivery]
• duration of labour stages [Срок оценки: during labour stages]
• Midwifery interventions during labour [Срок оценки: during labour (hours)]
• Variation in the anteroposterior diameter of the levator hiatus [Срок оценки: during labour (hours)]
• reasons for possible caesarean section [Срок оценки: immediately after caesarean section]
• Apgar Index at 1 min after delivery [Срок оценки: One minute after delivery]
• Apgar Index 5 minutes after delivery [Срок оценки: Five minutes after delivery]
• pH [Срок оценки: Within 1 hour after delivery]
• BE [Срок оценки: Within 1 hour after delivery]

Критерии участия

Критерии включения

• pregnant women with singleton pregnancies
• at term gestation (37 weeks)
• fetus in cephalic presentation
• absence of factors hindering vaginal delivery

Критерии исключения

• complicated pregnancies
• vaginal birth after Cesarean
• twin pregnancies
• early pregnancy
• women condition that exclude vaginal birth

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Италия · 3 центра

• Azienda Ospedaliero Universitaria Sant'Orsola Malpighi — Bologna
• Azienda Ospedale Università Padova — Padova
• Ospedale Cristo Re — Roma

Идентификаторы

NCT: NCT05718180 · MaPP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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