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Trial record 1 of 4 for:    risposta
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R. I. S. POS. T. A (RISPOSTA)

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ClinicalTrials.gov Identifier: NCT01991665
Recruitment Status : Unknown
Verified May 2017 by Tullio Ghi, University of Parma.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Tullio Ghi, University of Parma

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Vacuum Extraction; Failure, Affecting Fetus or Newborn Persistent Occiput Posterior Position During Labor Complication of Delivery Other: Digital examination Other: Sonography evaluation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991665


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

Locations
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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
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Principal Investigator: Tullio Ghi Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital
More Information
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Publications:

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Responsible Party: Tullio Ghi, Dr T. Ghi, Obstetrics and Prenatal Medicine Unit, University Hospital of Parma, University of Parma
ClinicalTrials.gov Identifier: NCT01991665    
Other Study ID Numbers: OST-2013-50
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Tullio Ghi, University of Parma:
Intrapartum Ultrasound
Vacuum
Occiput position