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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Bologna
Sponsor:
Information provided by (Responsible Party):
Tullio Ghi, University of Bologna
ClinicalTrials.gov Identifier:
NCT01991665
First received: November 17, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: January 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Digital examination before instrumental delivery to determine fetal head station and position
Other: Digital examination
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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")
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991665

Contacts
Contact: Tullio Ghi, Dr 0516364411 tullio.ghi@aosp.bo.it

Locations
Italy
Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Contact: Tullio Ghi    0516364411    tullio.ghi@aosp.bo.it   
Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Tullio Ghi Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Tullio Ghi, Dr T. Ghi, Obstetrics and Prenatal Medicine Unit, Sant'Orsola-Malpighi University Hospital, University of Bologna
ClinicalTrials.gov Identifier: NCT01991665     History of Changes
Other Study ID Numbers: OST-2013-50
Study First Received: November 17, 2013
Last Updated: April 9, 2014
Health Authority: Italy: National Institute of Health

Keywords provided by University of Bologna:
Intrapartum Ultrasound
Vacuum
Occiput position

ClinicalTrials.gov processed this record on August 20, 2014