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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Ultrasound AoP RS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with singleton pregnancies
- •at term gestation (37 weeks)
- •fetus in cephalic presentation
- •absence of factors hindering vaginal delivery
排除标准
- •complicated pregnancies
- •vaginal birth after Cesarean
- •twin pregnancies
- •early pregnancy
- •women condition that exclude vaginal birth
结局指标
主要结局
Ultrasound AoP RS
时间窗: During the resting step
To measure AoP (Angle of progression), expressed in degrees in the supine position and kneeling squat position in the same woman during the resting step (RS) up to 3 hours
Ultrasound MLA RS
时间窗: During the resting step
To measure MLA (MidlineAngle) expressed in degrees in the supine position and kneeling squat position in the same woman during the resting step up to 3 hours
Ultrasound HSD EP
时间窗: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
To measure the HSD (head-symphysis distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the expulsion phase up to 3 hours
Ultrasound HPD P
时间窗: During the push
To measure the HPD (head perineum distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the push up to 3 hours
Ultrasound AoP P
时间窗: During the push
To measure AoP (Angle of progression), expressed in degrees in the supine position and kneeling squat position in the same woman during the push (P) up to 3 hours
Ultrasound HSD RS
时间窗: During the resting step
To measure the HSD (head-symphysis distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the resting step up to 3 hours
Ultrasound HSD P
时间窗: During the push
To measure the HSD (head-symphysis distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the push up to 3 hours
Ultrasound MLA P
时间窗: During the push
To measure MLA (MidlineAngle) expressed in degrees in the supine position and kneeling squat position in the same woman during the push up to 3 hours
Ultrasound PAA RS
时间窗: During the resting step
To measure the PAA (pubic arch angle) expressed in degrees in the supine position and kneeling squat position in the same woman during the resting step up to 3 hours
Ultrasound HPD EP
时间窗: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
To measure the HPD (head perineum distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the expulsion phase up to 3 hours
Ultrasound AoP EP
时间窗: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
To measure AoP (Angle of progression), expressed in degrees in the supine position and kneeling squat position in the same woman during the expulsion phase (EP) up to 3 hours
Ultrasound PAA EP
时间窗: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
To measure the PAA (pubic arch angle) expressed in degrees in the supine position and kneeling squat position in the same woman during the expulsion phase up to 3 hours
Ultrasound PAA P
时间窗: During the push
To measure the PAA (pubic arch angle) expressed in degrees in the supine position and kneeling squat position in the same woman during the push up to 3 hours
Ultrasound MLA EP
时间窗: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
To measure MLA (MidlineAngle) expressed in degrees in the supine position and kneeling squat position in the same woman during the expulsion up to 3 hours
Ultrasound HPD RS
时间窗: During the resting step
To measure the HPD (head perineum distance) expressed in millimeters, in the supine position and kneeling squat position in the same woman during the resting step up to 3 hours
次要结局
- fetal position(at the beginning of delivery)
- pH(Within 1 hour after delivery)
- duration of labour stages(during labour stages)
- fetal weight(at delivery)
- Apgar Index at 1 min after delivery(One minute after delivery)
- reasons for possible caesarean section(immediately after caesarean section)
- mode of delivery(during delivery)
- Apgar Index 5 minutes after delivery(Five minutes after delivery)
- BE(Within 1 hour after delivery)