R. I. S. POS. T. A

Study Overview
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Brief Summary
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A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery. Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience. As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest. The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.

Official Title
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Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum

Conditions
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Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery

Intervention / Treatment
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* Other: Digital examination
* Other: Sonography evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery Exclusion Criteria: under 18 years of age women with contraindications for vacuum delivery women with sonography evaluation of fetal head position before randomization fetal head station > +3 discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise(fetal distress)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Digital examination before instrumental delivery to determine fetal head station and position | Other: Digital examination<br> <br> |
| Other: Group B<br>Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position | Other: Digital examination<br> <br> Other: Sonography evaluation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries). |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of: neonatal trauma (cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures), low Apgar scores, fetal acidosis or admission to the neonatal unit, shoulder dystocia |  | 2 years | 
| Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrapartum Ultrasound, Vacuum, Occiput position