Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1400 participants
INTERVENTIONAL
2014-01-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group A
Digital examination before instrumental delivery to determine fetal head station and position
Digital examination
Group B
Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position
Digital examination
Sonography evaluation
Interventions
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Digital examination
Sonography evaluation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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")
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Bologna
OTHER
Responsible Party
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Tullio Ghi
Dr T. Ghi, Obstetrics and Prenatal Medicine Unit, University Hospital of Parma
Principal Investigators
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Tullio Ghi
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital
Locations
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Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna
Bologna, Emilia-Romagna, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Groutz A, Hasson J, Wengier A, Gold R, Skornick-Rapaport A, Lessing JB, Gordon D. Third- and fourth-degree perineal tears: prevalence and risk factors in the third millennium. Am J Obstet Gynecol. 2011 Apr;204(4):347.e1-4. doi: 10.1016/j.ajog.2010.11.019. Epub 2010 Dec 22.
Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med. 1999 Dec 2;341(23):1709-14. doi: 10.1056/NEJM199912023412301.
Dupuis O, Silveira R, Zentner A, Dittmar A, Gaucherand P, Cucherat M, Redarce T, Rudigoz RC. Birth simulator: reliability of transvaginal assessment of fetal head station as defined by the American College of Obstetricians and Gynecologists classification. Am J Obstet Gynecol. 2005 Mar;192(3):868-74. doi: 10.1016/j.ajog.2004.09.028.
Akmal S, Kametas N, Tsoi E, Hargreaves C, Nicolaides KH. Comparison of transvaginal digital examination with intrapartum sonography to determine fetal head position before instrumental delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):437-40. doi: 10.1002/uog.103.
Ramphul M, Kennelly M, Murphy DJ. Establishing the accuracy and acceptability of abdominal ultrasound to define the foetal head position in the second stage of labour: a validation study. Eur J Obstet Gynecol Reprod Biol. 2012 Sep;164(1):35-9. doi: 10.1016/j.ejogrb.2012.06.001. Epub 2012 Jul 2.
Rozenberg P, Porcher R, Salomon LJ, Boirot F, Morin C, Ville Y. Comparison of the learning curves of digital examination and transabdominal sonography for the determination of fetal head position during labor. Ultrasound Obstet Gynecol. 2008 Mar;31(3):332-7. doi: 10.1002/uog.5267.
Zahalka N, Sadan O, Malinger G, Liberati M, Boaz M, Glezerman M, Rotmensch S. Comparison of transvaginal sonography with digital examination and transabdominal sonography for the determination of fetal head position in the second stage of labor. Am J Obstet Gynecol. 2005 Aug;193(2):381-6. doi: 10.1016/j.ajog.2004.12.011.
Wong GY, Mok YM, Wong SF. Transabdominal ultrasound assessment of the fetal head and the accuracy of vacuum cup application. Int J Gynaecol Obstet. 2007 Aug;98(2):120-3. doi: 10.1016/j.ijgo.2007.05.021. Epub 2007 Jun 22.
Other Identifiers
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OST-2013-50
Identifier Type: -
Identifier Source: org_study_id
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