Intrapartum Ultrasound for Assessment of Fetal Progression

Labor, Obstetric Clinical Trial

— Mapp  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05718180
• Other study ID #: Mapp
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: University of Padova
• Contact: Alessia Selmin
• Phone: +390498214434
• Email: alessia.selmin[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 177
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labor, Obstetric

Intervention

Other:
• Transperineal imaging
To measure the difference between ultrasound parameters based on maternal position: to measure the variation of AoP (Angle of progression), MLA (Midline Angle), PAA(pubic arch angle expressed in grades) HSD (head-symphysis distance) 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Orsola Malpighi	Bologna
Italy	Azienda Ospedale Università Padova	Padova
Italy	Ospedale Cristo Re	Roma

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
Primary	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	During the resting step
Primary	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	During the push
Primary	Ultrasound MLA EP	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	Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
Primary	Ultrasound MLA RS	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	During the resting step
Primary	Ultrasound MLA P	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	During the push
Primary	Ultrasound PAA EP	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	Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
Primary	Ultrasound PAA RS	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	During the resting step
Primary	Ultrasound PAA P	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	During the push
Primary	Ultrasound HSD EP	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	Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
Primary	Ultrasound HSD RS	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	During the resting step
Primary	Ultrasound HSD P	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	During the push
Primary	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	Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
Primary	Ultrasound HPD RS	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	During the resting step
Primary	Ultrasound HPD P	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	During the push
Secondary	mode of delivery	mode of delivery	during delivery
Secondary	duration of labour stages	duration of labour stages up to 18 hours	during labour stages
Secondary	fetal weight	fetal weight	at delivery
Secondary	fetal position	fetal position	at the beginning of delivery
Secondary	reasons for possible caesarean section	reasons for possible caesarean section	immediately after caesarean section
Secondary	Apgar Index at 1 min after delivery	Apgar Index	One minute after delivery
Secondary	Apgar Index 5 minutes after delivery	Apgar Index	Five minutes after delivery
Secondary	pH	pH	Within 1 hour after delivery
Secondary	BE	Bases excess	Within 1 hour after delivery