Maternal and newborn health are primary areas of focus for governments and health agencies, and key areas of unmet need for innovation in medical technology.
newborns died in 2019, about 1 million of them in the first 24 hours7.
babies are stillborn every year. Most of these deaths are preventable8.
died in 2020 from complications of pregnancy and childbirth. Most of these deaths were preventable9.
Approximately 25% of newborn mortality10 and 45% of stillbirths8 occur during the process of childbirth.
Approximately 10 million women each year incur serious pregnancy-related complications11.
Prolonged or complicated second stage of labour requiring an assisted vaginal birth or an emergency cesarean section occurs in approximately 10-15% of births12.
Assisted vaginal birth can be safer than an emergency cesarean section in the short and long term for mothers and babies, and should be recommended as the mode of delivery13.
In comparison with cesarean section, assisted vaginal birth is associated with a reduced risk of maternal haemorrhage14, intrapartum stillbirth16, admission to intensive care for newborns14, abnormally invasive placenta17 and stillbirth in subsequent pregnancies18.
“When we reduce unnecessary caesarean sections, we also reduce unnecessary risks to women and their babies. We also reduce unnecessary costs for hospitals and health systems.”15
-WHO Department of Reproductive Health and Research
In a clinical trial, women and midwives articulated views suggesting the common belief that forceps are more ‘traumatic’ either physically or emotionally2.
In a clinical trial, midwives perceived that the OdonAssist™ is kinder than other devices and described the births as ‘softer’, ‘nicer’, ‘beautiful’, ‘easy’, ‘smooth’ and ‘gentle’ 2.
In all clinical trials OdonAssist was demonstrated to be safe for the baby, with no typical pattern of the neonatal bruising or injury associated with use of forceps or vacuum extraction3-5.
The efficacy (successful assisted birth) rate with OdonAssist™ in clinical trials was up to 88.5%5.
If OdonAssist does not deliver the newborn it can be removed easily, allowing for other interventions.
Unlike forceps and vacuum extraction, with OdonAssist the insertion technique is the same for all fetal head positions in cephalic presentations3-5.
Data, evidence and expert opinion about the OdonAssist device have been published in more than 20 medical publications. View the most current here.
Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England.
The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy-The ASSIST II study.
1. Baskett TF. Operative vaginal delivery – an historical perspective. Best Pract Res Clin Obstet Gynaecol. 2019 Apr;56:3-10.
2. Hotton et al. Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England. BMJ Open. 2021;11:e057023.
3. Hotton et al. Outcomes of the novel Odon Device in indicated operative vaginal birth. Am J Obstet Gynecol. 2021;224:607.e1-607.e17.
4. Hotton et al. The OdonAssist™ inflatable device for assisted vaginal birth – the ASSIST II study (UK). Am J Obstet Gynecol. [In press.]
5. Mottet et al. Safety and efficacy of the OdonAssist™ inflatable device for assisted vaginal birth: the Besancon ASSIST study. Am J Obstet Gynecol. [In press.] NB. Efficacy rates reported in the ASSIST II study and subsequent Besançon ASSIST study, conducted in 104 women each, were 66.3% and 88.5% respectively
6. WHO. Newborns: improving survival and well-being. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality. Published 19 September 2020. Accessed 24 May 2023.
7. WHO. Newborn Mortality. https://www.who.int/news-room/fact-sheets/detail/levels-and-trends-in-child-mortality-report-2021. Published 28 January 2022. Accessed 24 May 2023.
8. (UNIGME) UNIG for CME. Never Forgotten: the situation of stillbirth around the globe. Report of the United Nations inter-agency group for child mortality estimation, 2022. Available: https://childmortality.org/wp-content/uploads/2023/03/UN-IGME-Stillbirth-Report-2022.pdf [Accessed 17 Apr 2023].
9. WHO. Maternal mortality. https://www.who.int/news-room/fact-sheets/detail/maternal-mortality. Published 22 Feb 2023. Accessed 10 Apr 2023.
10. (UNIGME) UNIG for CME. Levels & trends in child mortality: report 2019, estimates developed by the United Nations inter-agency group for child mortality estimation [online], 2019. Available: https://data.unicef.org/resources/levels-and-trends-in-child-mortality-2019 Accessed 25 Apr 2023.
11. UNICEF. The State of the World’s Children 2009: Maternal and newborn health. New York: UNICEF; 2009. https://www.unicef.org/reports/state-worlds-children-2009
12. Royal College of Obstetricians & Gynaecologists. Assisted vaginal birth. https://www.rcog.org.uk/media/2p4fh2kd/pi-vaginal-birth-final-28042020.pdf. Published April 2020. Accessed 03 Apr 2023.
13. Thierens et al. Vacuum extraction or caesarean section in the second stage of labour: A systematic review. BJOG. 2023;130:586-598.
14. Murphy DJ, Liebling RE, Verity L, Swingler R, Patel R. Early maternal and neonatal morbidity associated with operative delivery in second stage of labour: a cohort study. Lancet. 2001 Oct 13;358(9289):1203-7. doi: 10.1016/S0140-6736(01)06341-3. PMID: 11675055.
15. WHO. New WHO guidance on non-clinical interventions specifically designed to reduce unnecessary caesarean sections. https://www.who.int/news/item/11-10-2018-new-who-guidance-on-non-clinical-interventions-specifically-designed-to-reduce-unnecessary-caesarean-sections. Published 11 October 2018. Accessed 31 March 2023.
16. Nolens et al. Use of assisted vaginal birth to reduce unnecessary caesarean sections and improve maternal and perinatal outcomes. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30043-9/fulltext. Lancet Glob Health 2019;7:e408-e409.
17. Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi:10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6. PMID: 22114995.
18. Moraitis AA, Oliver-Williams C, Wood AM, Fleming M, Pell JP, Smith G. Previous caesarean delivery and the risk of unexplained stillbirth: retrospective cohort study and meta-analysis. BJOG. 2015 Oct;122(11):1467-74. doi:10.1111/1471-0528.13461. Epub 2015 May 29. PMID: 26033155.
19. NIH. Cesarean Section – A Brief History. Located in US National Library of Medicine. https://www.nlm.nih.gov/exhibition/cesarean/part1.html. Updated 26 July 2013. Accessed 6 April 2023.
20. Blackstone F, Katukuri V. Will vacuum delivery go the way of vaginal breech delivery? Contemp Ob Gyn. 2019 Jul 10; Vol 64 No 07.
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