PROPENSITY-ID: Sonographic and Clinical Assessment of Head Position Prior to Instrumental Delivery and Labour Outcomes

NCT05557097 | Unknown

• 1 other identifier: 337/2022/OSS/UNIPR
• Study Type: observational
• Target: 2,282
• Locations: 1 country
• Sites: 1

Brief Summary

Instrumental delivery is performed in 3-15% of all births (1). Successful instrumental delivery avoids need for cesarean section with associated maternal surgical morbidity, risk from neonatal disimpaction and future pregnancy implications. However, instrumental birth carries risk of maternal perineal and anal sphincter injury, postpartum haemorrhage, shoulder dystocia and fetal trauma (2,3). Additionally, failure of instrumental birth requires delivery by cesarean section with a more deeply impacted fetal head, resulting in compounding of fetal and maternal risks (3,4). Therefore, appropriately identifying women that are at risk of failed instrumental birth is important to reduce maternal and neonatal morbidity. Fetal head position and station are key determinants in success of instrumental birth, traditionally assessed with digital vaginal examination (1,5). There is now high quality evidence showing that intrapartum ultrasound is a more reliable tool in determining fetal head position and station compared to digital vaginal examination (6,7). Additionally, intrapartum ultrasound has been shown to predict outcome of instrumental birth and improve accuracy of instrument placement (8-11). However, no randomised studies to date have demonstrated a benefit in maternal and neonatal morbidity from using intrapartum ultrasound, possibly due to being underpowered. Low recruitment of studies has been suggested to occur due to practitioners electing to use ultrasound rather than randomise participants, despite the absence of evidence supporting clinical benefit (13). This study aims to evaluate whether the assessment of the fetal occiput position by intrapartum sonography before instrumental delivery improves labour outcomes by using an observational design with propensity score matching analysis. This international multicentre prospective observational study will compare outcomes of two parallel groups:

• Group 1: patients submitted to instrumental delivery preceded by the use of ultrasound for the assessment of the occiput position by clinicians who routinely perform intrapartum sonography as an adjunct to clinical examination prior to vacuum delivery
• Group 2: patients having submitted to instrumental delivery without the adjunct of by clinicians not performing intrapartum sonography prior to vacuum delivery The investigators will perform a propensity score (PS) matching analysis to assess the effect of US as an adjunct to clinical examination prior to instrumental delivery on the occurrence of failed instrumental delivery, adjusting for important differences in baseline characteristics between groups to reduce confounding bias. The investigators will assess two primary outcomes of vaginal delivery and composite adverse perinatal outcome in additional to maternal morbidity and instrumental failure rates.

Conditions

Instrumental Delivery; NEC, Affecting Fetus or Newborn; Second Stage Cesarean Delivery; Occiput Position

Keywords

Vacuum extractor; Forceps; Vaginal examination; Intrapartum ultrasound

Outcome Measures

Primary Outcomes (2)

• Vaginal delivery

  Achieve delivery of the neonate vaginally via vacuum or forceps delivery

  At time of successful birth of the neonate

• Composite adverse perinatal outcome

  Occurrence of either shoulder dystocia, acidaemia (as defined by cord umbilical pH \<7.0 and/or a base excess \>12.0), Apgar score \<7 at 5 minutes, neonatal injury (intracranial haemorrhage, skull fracture), NICU admission, hypoxic-ischemic encephalopathy and death

  up to 100 weeks after delivery

Secondary Outcomes (2)

• Maternal morbidity

  up to 100 weeks after delivery

• Sequential instrumental delivery by forceps

  up to 100 weeks after delivery

Study Arms (2)

Group ultrasound + vaginal examination

Patients submitted to instrumental delivery by clinicians who routinely perform intrapartum sonography as an adjunct to clinical examination prior to vacuum delivery

Diagnostic Test: Intrapartum sonography

Group vaginal examination

Patients submitted to instrumental delivery by clinicians not performing intrapartum sonography prior to vacuum delivery

Interventions

Intrapartum sonography DIAGNOSTIC_TEST

Intrapartum ultrasound performed as an adjunct to clinical examination to assess fetal occiput position prior to performing vacuum delivery

Group ultrasound + vaginal examination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an international multicentre study involving tertiary maternity units with a reported instrumental delivery rate at or above 5%. Women \>18 years old, with singleton pregnancies, fetus in cephalic presentation, and gestation \>36 weeks admitted to labour ward will be consented for pseudoanonymized data collection in the event of instrumental delivery. Participants that proceed to have an indication for instrumental delivery will be included in the data collection

You may qualify if:

• Non-anomalous singleton pregnancies
• Cephalic presenting fetus
• Gestational age \> 36+0 weeks
• Clinical indication for instrumental delivery

You may not qualify if:

• Any contraindication to instrumental delivery
• Maternal age \<18 years

Sponsors & Collaborators

• University of Parma: lead
• Monash Medical Centre: collaborator
• University Hospital of Torrejon: collaborator

Study Sites (1)

University of Parma

Parma, 43126, Italy

RECRUITING

Related Publications (18)

• Murphy DJ, Strachan BK, Bahl R; Royal College of Obstetricians and Gynaecologists. Assisted Vaginal Birth: Green-top Guideline No. 26. BJOG. 2020 Aug;127(9):e70-e112. doi: 10.1111/1471-0528.16092. Epub 2020 Apr 28. No abstract available.

  PMID: 32346983 BACKGROUND

• 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

• Le Brun C, Beucher G, Morello R, Jones F, Lamendour N, Dreyfus M. [Failure of vacuum extractions: risk factors, maternal and fetal issues]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):693-702. doi: 10.1016/j.jgyn.2013.04.003. Epub 2013 May 20. French.

  PMID: 23702434 BACKGROUND

• Ramphul M, Kennelly MM, Burke G, Murphy DJ. Risk factors and morbidity associated with suboptimal instrument placement at instrumental delivery: observational study nested within the Instrumental Delivery & Ultrasound randomised controlled trial ISRCTN 72230496. BJOG. 2015 Mar;122(4):558-63. doi: 10.1111/1471-0528.13186. Epub 2014 Nov 21.

  PMID: 25414081 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

• 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

• Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072.

  PMID: 29974596 BACKGROUND

• Kahrs BH, Usman S, Ghi T, Youssef A, Torkildsen EA, Lindtjorn E, Ostborg TB, Benediktsdottir S, Brooks L, Harmsen L, Romundstad PR, Salvesen KA, Lees CC, Eggebo TM. Sonographic prediction of outcome of vacuum deliveries: a multicenter, prospective cohort study. Am J Obstet Gynecol. 2017 Jul;217(1):69.e1-69.e10. doi: 10.1016/j.ajog.2017.03.009. Epub 2017 Mar 19.

  PMID: 28327433 BACKGROUND

• Bultez T, Quibel T, Bouhanna P, Popowski T, Resche-Rigon M, Rozenberg P. Angle of fetal head progression measured using transperineal ultrasound as a predictive factor of vacuum extraction failure. Ultrasound Obstet Gynecol. 2016 Jul;48(1):86-91. doi: 10.1002/uog.14951. Epub 2016 Jun 10.

  PMID: 26183426 BACKGROUND

• Ramphul M, Ooi PV, Burke G, Kennelly MM, Said SA, Montgomery AA, Murphy DJ. Instrumental delivery and ultrasound : a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery. BJOG. 2014 Jul;121(8):1029-38. doi: 10.1111/1471-0528.12810. Epub 2014 Apr 11.

  PMID: 24720273 BACKGROUND

• Ghi T, Dall'Asta A, Masturzo B, Tassis B, Martinelli M, Volpe N, Prefumo F, Rizzo G, Pilu G, Cariello L, Sabbioni L, Morselli-Labate AM, Todros T, Frusca T. Randomised Italian Sonography for occiput POSition Trial Ante vacuum (R.I.S.POS.T.A.). Ultrasound Obstet Gynecol. 2018 Dec;52(6):699-705. doi: 10.1002/uog.19091. Epub 2018 Nov 8.

  PMID: 29785716 BACKGROUND

• Barros JG, Afonso M, Martins AT, Carita AI, Clode N, Ayres-de-Campos D, Graca LM. Transabdominal and transperineal ultrasound vs routine care before instrumental vaginal delivery - A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Jun;100(6):1075-1081. doi: 10.1111/aogs.14065. Epub 2021 Jan 12.

  PMID: 33319355 BACKGROUND

• Bellussi F, Di Mascio D, Salsi G, Ghi T, Dall'Asta A, Zullo F, Pilu G, Barros JG, Ayres-de-Campos D, Berghella V. Sonographic knowledge of occiput position to decrease failed operative vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2022 Apr;226(4):499-509. doi: 10.1016/j.ajog.2021.08.057. Epub 2021 Sep 4.

  PMID: 34492220 BACKGROUND

• Mappa I, Tartaglia S, Maqina P, Makatsariya A, Ghi T, Rizzo G, D'Antonio F. Ultrasound vs routine care before instrumental vaginal delivery: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2021 Nov;100(11):1941-1948. doi: 10.1111/aogs.14236. Epub 2021 Aug 8.

  PMID: 34314520 BACKGROUND

• Ghi T, Youssef A. Does ultrasound determination of fetal occiput position improve labour outcome? BJOG. 2014 Sep;121(10):1312. doi: 10.1111/1471-0528.12956. No abstract available.

  PMID: 25155321 BACKGROUND

• Dall'Asta A, Rizzo G, Ghi T. Intrapartum ultrasound before instrumental vaginal delivery: Clinical benefits are difficult to demonstrate. Acta Obstet Gynecol Scand. 2021 May;100(5):988-989. doi: 10.1111/aogs.14082. Epub 2021 Feb 5. No abstract available.

  PMID: 33423283 BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Andrea Dall'Asta, MD, PhD

CONTACT

+390521903551; andrea.dallasta@unipr.it

Davide Molena, Dr

CONTACT

+390521906641; davide.molena@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 27, 2022
• Study Start: August 30, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 11, 2023

Record last verified: 2022-06

Locations

IT (1)