Trials / Unknown
UnknownNCT01991665
R. I. S. POS. T. A
Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,400 (estimated)
- Sponsor
- University of Bologna · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
- Vacuum Extraction; Failure, Affecting Fetus or Newborn
- Persistent Occiput Posterior Position During Labor
- Complication of Delivery
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Digital examination | |
| OTHER | Sonography evaluation |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2017-12-01
- Completion
- 2018-04-01
- First posted
- 2013-11-25
- Last updated
- 2017-05-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01991665. Inclusion in this directory is not an endorsement.