Complication of Delivery, Persistent Occiput Posterior Position During Labor, Vacuum Extraction; Failure, Affecting Fetus or Newborn
Conditions
Keywords
Intrapartum Ultrasound, Vacuum, Occiput position
Brief 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.
Interventions
OTHERDigital examination
OTHERSonography evaluation
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Contacts
Primary ContactTullio Ghi, Dr
Outcome results
None listed