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

May 2, 2017 updated by: Tullio Ghi, University of Bologna

Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Digital examination before instrumental delivery to determine fetal head station and position
Other: Digital examination
Other: Group B
Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position
Other: Digital examination
Other: Sonography evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome 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
Time Frame: 2 years
2 years
Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Tullio Ghi, Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

November 17, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OST-2013-50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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