R. I. S. POS. T. A (RISPOSTA)

University of Bologna

Status: Unknown

Conditions: Persistent Occiput Posterior Position During Labor; Vacuum Extraction; Failure, Affecting Fetus or Newborn; Complication of Delivery

Treatments: Other: Digital examination; Other: Sonography evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT01991665

OST-2013-50

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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")

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Group A

Other group

Description:

Digital examination before instrumental delivery to determine fetal head station and position

Treatment:

Other: Digital examination

Group B

Other group

Description:

Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position

Treatment:

Other: Sonography evaluation

Other: Digital examination