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NCT01991665 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2017-05-03

No results posted yet for this study

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

OTHER

Digital examination

OTHER

Sonography evaluation

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Tullio Ghi · Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-31
Completion
2018-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991665 on ClinicalTrials.gov