Clinical trial NCT05718180: Intrapartum Ultrasound for Assessment of Fetal Progression
Official title: Intrapartum Ultrasound for Assessment of Fetal Progression: a Randomised Controlled Trial to Evaluate the Variation of AoP, HSD, HPD, MLA, PAA According to Maternal Position and Pelvis (MaPP Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor, Obstetric
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Padova
First posted: 2023-02-08
Enrollment: 177
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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, HSD, HPD, PAA 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: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ultrasound AoP EP
timeFrame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
measure: Ultrasound AoP RS
timeFrame: During the resting step
measure: Ultrasound AoP P
timeFrame: During the push
measure: Ultrasound MLA EP
timeFrame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
measure: Ultrasound MLA RS
timeFrame: During the resting step
measure: Ultrasound MLA P
timeFrame: During the push
measure: Ultrasound PAA EP
timeFrame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
measure: Ultrasound PAA RS
timeFrame: During the resting step
measure: Ultrasound PAA P
timeFrame: During the push
measure: Ultrasound HSD EP
timeFrame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
measure: Ultrasound HSD RS
timeFrame: During the resting step
measure: Ultrasound HSD P
timeFrame: During the push
measure: Ultrasound HPD EP
timeFrame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
measure: Ultrasound HPD RS
timeFrame: During the resting step
measure: Ultrasound HPD P
timeFrame: During the push
Secondary outcomes:
measure: mode of delivery
timeFrame: during delivery
measure: duration of labour stages
timeFrame: during labour stages
measure: fetal weight
timeFrame: at delivery
measure: fetal position
timeFrame: at the beginning of delivery
measure: reasons for possible caesarean section
timeFrame: immediately after caesarean section
measure: Apgar Index at 1 min after delivery
timeFrame: One minute after delivery
measure: Apgar Index 5 minutes after delivery
timeFrame: Five minutes after delivery
measure: pH
timeFrame: Within 1 hour after delivery
measure: BE
timeFrame: Within 1 hour after delivery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Roma
country: Italy
facility: Ospedale Cristo Re
Study officials:
References: