R. I. S. POS. T. A

NCT01991665 | Unknown DMC

• 1 other identifier: OST-2013-50
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intrapartum Ultrasound; Vacuum; Occiput position

Outcome Measures

Primary Outcomes (1)

• failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).

  2 years

Secondary Outcomes (2)

• 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

• Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears

  2 years

Study Arms (2)

Group A

OTHER

Digital examination before instrumental delivery to determine fetal head station and position

Other: Digital examination

Group B

OTHER

Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position

Other: Digital examination; Other: Sonography evaluation

Interventions

Digital examination OTHER

Group A; Group B

Sonography evaluation OTHER

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery

You may not qualify if:

• 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")

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 21183150 BACKGROUND

• 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.

  PMID: 10580069 BACKGROUND

• 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.

  PMID: 15746684 BACKGROUND

• 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.

  PMID: 12768552 BACKGROUND

• 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.

  PMID: 22762840 BACKGROUND

• 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.

  PMID: 18307213 BACKGROUND

• 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.

  PMID: 16098859 BACKGROUND

• 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.

  PMID: 17585916 BACKGROUND

Study Officials

• Tullio Ghi

  Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tullio Ghi, Dr

CONTACT

0516364411; tullio.ghi@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr T. Ghi, Obstetrics and Prenatal Medicine Unit, University Hospital of Parma

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

IT (1)