Labor, ObstetricMaPPNCT05718180
Intrapartum Ultrasound for Assessment of Fetal Progression
A study testing Transperineal imaging in people with Labor, Obstetric, run by University of Padova at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Obstetric
- What is being tested?
- Transperineal imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jul 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women with singleton pregnancies
- at term gestation (37 weeks)
- fetus in cephalic presentation
- absence of factors hindering vaginal delivery
Who cannot join
- complicated pregnancies
- vaginal birth after Cesarean
- twin pregnancies
- early pregnancy
- women condition that exclude vaginal birth
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Honoria Ocagli, PhD contact
Italy3 sites
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
Bologna
Aly Youssef, aly.youssef78@gmail.com
Aly Youssef, MD
Azienda Ospedale Università Padova
Padova
Alessia Selmin, alessia.selmin@unipd.it
Silvia Visentin, MD
Ospedale Cristo Re
Roma
Ilenia Mappa, MD, mappa.ile@gmail.com
Giuseppe Rizzo, MD, giuseppe.rizzo@uniroma2.it
About this study
Official 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)
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.
Read more
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.
- Conditions
- Labor, Obstetric
- Being tested
- Transperineal imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal imagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women undergoing positional ultrasound assessment | Experimental | Before the onset of labour, the woman will be randomized to the order of the position during the intrapartum transperineal ultrasound (firstly supine position and secondly kneeling-squat, or vice-versa). Receives: Other: Transperineal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
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
Measured: During the resting step
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
Measured: During the push
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
Measured: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.
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
Measured: During the resting step
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
Measured: During the push
Secondary outcomes (9)
mode of delivery
mode of delivery
Measured: during delivery
duration of labour stages
duration of labour stages up to 18 hours
Measured: during labour stages
Midwifery interventions during labour
Midwifery interventions during labour
Measured: during labour (hours)
Variation in the anteroposterior diameter of the levator hiatus
Variation in the anteroposterior diameter of the levator hiatus
Measured: during labour (hours)
reasons for possible caesarean section
reasons for possible caesarean section
Measured: immediately after caesarean section
Apgar Index at 1 min after delivery
Apgar Index
Measured: One minute after delivery
Apgar Index 5 minutes after delivery
Apgar Index
Measured: Five minutes after delivery
pH
pH
Measured: Within 1 hour after delivery
BE
Bases excess
Measured: Within 1 hour after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, single-group interventional study with randomized intra-subject comparison of assessment positions.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718180
- Sponsor's protocol ID
- MaPP
- Acronym
- MaPP
- Status last verified
- Jun 2026
- First submitted
- 6 May 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05718180
- Acronym / sponsor ID
- MaPP / MaPP
- Conditions
- Labor, Obstetric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single-group interventional study with randomized intra-subject comparison of assessment positions.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women undergoing positional ultrasound assessment | Experimental | Other: Transperineal imagingBefore the onset of labour, the woman will be randomized to the order of the position during the intrapartum transperineal ultrasound (firstly supine position and secondly kneeling-squat, or vice-versa). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women with singleton pregnancies
- at term gestation (37 weeks)
- fetus in cephalic presentation
- absence of factors hindering vaginal delivery
Key exclusion criteria (5 listed)
- complicated pregnancies
- vaginal birth after Cesarean
- twin pregnancies
- early pregnancy
- women condition that exclude vaginal birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal imagingTo 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. | Other | Pregnant women undergoing positional ultrasound assessment |
Primary outcome
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
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
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
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
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
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
9 secondary outcomes
mode of delivery
Time frame: during delivery
duration of labour stages
Time frame: during labour stages
Midwifery interventions during labour
Time frame: during labour (hours)
Variation in the anteroposterior diameter of the levator hiatus
Time frame: during labour (hours)
reasons for possible caesarean section
Time frame: immediately after caesarean section
Apgar Index at 1 min after delivery
Time frame: One minute after delivery
Apgar Index 5 minutes after delivery
Time frame: Five minutes after delivery
pH
Time frame: Within 1 hour after delivery
BE
Time frame: Within 1 hour after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Honoria Ocagli, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal imaging in people with Labor, Obstetric, run by University of Padova at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia Selmin (+390498214434, alessia.selmin@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound AoP EP (time frame: Beginning of the expulsive phase (active second stage): with complete dilation and the perception of an urge to push.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.