Intrapartum Ultrasound for Assessment of Fetal Progression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Padova

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

pregnant women with singleton pregnancies

at term gestation (37 weeks)

fetus in cephalic presentation

absence of factors hindering vaginal delivery

Disqualifiers

complicated pregnancies

vaginal birth after Cesarean

twin pregnancies

early pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Transperineal imaging

    Other intervention

    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.

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: Pregnant women undergoing positional ultrasound assessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ultrasound AoP EP

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

Time frame
Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
2

Ultrasound AoP RS

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

Time frame
During the resting step
3

Ultrasound AoP P

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

Time frame
During the push
4

Ultrasound HPD EP

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

Time frame
Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.

Secondary outcomes

1

mode of delivery

mode of delivery

Time frame
during delivery
2

duration of labour stages

duration of labour stages up to 18 hours

Time frame
during labour stages
3

Midwifery interventions during labour

Midwifery interventions during labour

Time frame
during labour (hours)
4

Variation in the anteroposterior diameter of the levator hiatus

Variation in the anteroposterior diameter of the levator hiatus

Time frame
during labour (hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Padova

Lead sponsor

Azienda Ospedaliera di Padova

Collaborator

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