R. I. S. POS. T. A (RISPOSTA)
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.
Vacuum Extraction; Failure, Affecting Fetus or Newborn
Persistent Occiput Posterior Position During Labor
Complication of Delivery
Other: Digital examination
Other: Sonography evaluation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum|
- failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Digital examination before instrumental delivery to determine fetal head station and position
|Other: Digital examination|
Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position
|Other: Digital examination Other: Sonography evaluation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01991665
|Contact: Tullio Ghi, Drfirstname.lastname@example.org|
|Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna||Recruiting|
|Bologna, Emilia-Romagna, Italy, 40138|
|Contact: Tullio Ghi 0516364411 email@example.com|
|Principal Investigator:||Tullio Ghi||Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital|