R. I. S. POS. T. A

Not Applicable

• Conditions: Vacuum Extraction; Failure, Affecting Fetus or Newborn; Persistent Occiput Posterior Position During Labor; Complication of Delivery
• Interventions: Other: Digital examination; Other: Sonography evaluation

• Registration Number: NCT01991665
• Lead Sponsor: University of Bologna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-17
• Study First Submitted QC: 2013-11-17
• Study First Posted: 2013-11-25
• Study Start: 2014-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Primary Completion: 2017-12
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1400

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")

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Sonography evaluation	Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position
Group A	Digital examination	Digital examination before instrumental delivery to determine fetal head station and position
Group B	Digital examination	Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna; 🇮🇹 Bologna, Emilia-Romagna, Italy