R. I. S. POS. T. A

N/AUnknownNCT01991665

University of Bologna1,400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,400

Conditions

Vacuum Extraction; Failure, Affecting Fetus or Newborn Persistent Occiput Posterior Position During Labor

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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")

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

R. I. S. POS. T. A

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts