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NCT Number: NCT05718180

Intrapartum Ultrasound for Assessment of Fetal Progression

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Sant'Orsola Malpighi, Bologna, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transperineal imaging

Other

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.

Primary outcomes

  1. Ultrasound AoP EP

    Time frame: 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

  2. Ultrasound AoP RS

    Time frame: 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

  3. Ultrasound AoP P

    Time frame: 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

  4. Ultrasound HPD EP

    Time frame: 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

  5. Ultrasound HPD RS

    Time frame: 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

  6. Ultrasound HPD P

    Time frame: 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

Secondary outcomes

  1. mode of delivery

    Time frame: during delivery

    mode of delivery

  2. duration of labour stages

    Time frame: during labour stages

    duration of labour stages up to 18 hours

  3. Midwifery interventions during labour

    Time frame: during labour (hours)

    Midwifery interventions during labour

  4. Variation in the anteroposterior diameter of the levator hiatus

    Time frame: during labour (hours)

    Variation in the anteroposterior diameter of the levator hiatus

  5. reasons for possible caesarean section

    Time frame: immediately after caesarean section

    reasons for possible caesarean section

  6. Apgar Index at 1 min after delivery

    Time frame: One minute after delivery

    Apgar Index

  7. Apgar Index 5 minutes after delivery

    Time frame: Five minutes after delivery

    Apgar Index

  8. pH

    Time frame: Within 1 hour after delivery

    pH

  9. BE

    Time frame: Within 1 hour after delivery

    Bases excess

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia Selmin

CONTACT

[email protected]

+390498214434

Honoria Ocagli, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Azienda Ospedaliera di Padova

Registry information

Official study title

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)

Acronym: MaPP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 8, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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