R. I. S. POS. T. A

Complication of Delivery Clinical Trial

— RISPOSTA  

Official title:

Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991665
• Other study ID #: OST-2013-50
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2013
• Last updated: May 2, 2017
• Start date: January 2014
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: University of Bologna
• Contact: Tullio Ghi, Dr
• Phone: 0516364411
• Email: tullio.ghi[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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")

Related Conditions & MeSH terms

• Complication of Delivery
• Persistent Occiput Posterior Position During Labor
• Vacuum Extraction; Failure, Affecting Fetus or Newborn

Intervention

Other:
• Digital examination

• Sonography evaluation

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna	Bologna	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jun 22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).		2 years
Secondary	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		2 years
Secondary	Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears		2 years

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