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)
| Registry | NCT05718180, acronym MaPP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 105 (Estimated) |
| Sponsor | University of Padova (Other); collaborators: Azienda Ospedaliera di Padova |
| Conditions | Labor, Obstetric |
| Interventions | Transperineal imaging (Other) |
| Dates | start 2026-07-01 (estimated), primary completion 2029-07-31 (estimated), completion 2029-07-31 (estimated), first posted 2023-02-08, last updated 2026-06-18 |
| Locations | 3 sites in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Labor, Obstetric All trials of Transperineal imaging
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pregnant women undergoing positional ultrasound assessment | Experimental | Other: Transperineal imaging | 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). |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Sant'Orsola Malpighi | Bologna | Italy | |
| Azienda Ospedale Università Padova | Padova | Italy | |
| Ospedale Cristo Re | Roma | Italy |