R. I. S. POS. T. A (RISPOSTA)
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|ClinicalTrials.gov Identifier: NCT01991665|
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Vacuum Extraction; Failure, Affecting Fetus or Newborn Persistent Occiput Posterior Position During Labor Complication of Delivery||Other: Digital examination Other: Sonography evaluation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
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|
- 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 ]
- 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 ]
- Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991665
|Contact: Tullio Ghi, Dremail@example.com|
|Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna||Recruiting|
|Bologna, Emilia-Romagna, Italy, 40138|
|Contact: Tullio Ghi 0516364411 firstname.lastname@example.org|
|Principal Investigator:||Tullio Ghi||Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital|