ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device

NCT06918509 | Completed DMC

• 1 other identifier: CUAMM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal risks. Increasing access to AVD has been identified by the World Health Organization (WHO) as one of the priorities for improving maternal health globally. The OdonAssist™ is a frugal innovation born in the southern hemisphere in an unconventional environment. It was invented by an Argentinian mechanic, Jorge Odon. Its potential to improve maternal and neonatal health is now recognised. It has been designed to be safe, simple to use and better accepted than current devices (forceps, suction cup). Two studies conducted in England and one in France have confirmed these characteristics and funding has recently been obtained for a randomised clinical investigation in five French hospitals. Project Rationale The present project aims to conduct a feasibility study at Saint Luke's Hospital in Wolisso, a poorly resourced hospital in rural Ethiopia, in order to test the device in a low-income country and assess its acceptability. In addition, with the aim of investigating the efficiency and budgetary impact of this new device, and considering the wider perspective of a future scale-up, data will be collected on its cost-effectiveness, in order to compare it with the reference interventions at local level (vacuum and caesarean section). Main research questions:

1. 1.Is it feasible to introduce the OdonAssist™ (new intervention) at the hospital Saint Luke's in Ethiopia, in terms of preliminary data on safety, efficacy, acceptability by mothers and healthcare providers?
2. 2.What are the estimated healthcare-related costs of the OdonAssist™ (new intervention) in comparison to traditional alternatives, that are vacuum-assisted delivery or cesarean section during the second stage of labor?

Conditions

Instrumental Delivery; Feasibility Study; Acceptability Study; Pregnancy; Medical Device

Keywords

OdonAssistTM; Instrumental delivery; Medical device; Feasibility study; Acceptability study; pregnancy

Outcome Measures

Primary Outcomes (1)

• Efficacy of delivery assistance with the OdonAssistTM medical device

  Rate of births successfully assisted with the OdonAssist. An assisted vaginal birth will be defined as 'successful' if all of the following criteria are met: * The birth of the baby is expedited with the OdonAssist. (without sequential use of other AVB devices or resorting to cesarean section). * There are no serious maternal adverse reactions related to the use of the device during birth. * There are no serious neonatal adverse reactions related to the use of the device during birth

  From enrollment to 6 weeks postpartum

Secondary Outcomes (27)

• Maternal safety - Weighed blood loss (grams)

  From enrollment to 6 weeks postpartum

• Maternal safety - Perineal and anal sphincter injury

  From enrollment to 6 weeks postpartum

• Maternal safety - Ischio-rectal fossa defect

  From enrollment to 6 weeks postpartum

• Maternal safety - Cervical tear

  From enrollment to 6 weeks postpartum

• Maternal safety - cesarean section performed

  From enrollment to 6 weeks postpartum

Study Arms (1)

OdonAssistTM medical device

EXPERIMENTAL

The ASSIST Ethiopia Study is a feasibility study of women who require an assisted vaginal birth (AVB) for a recognized clinical indication. Assistance will be performed using the OdonAssistTM medical device.

Device: OdonAssistTM

Interventions

OdonAssistTM DEVICE

Innovative medical device for operative vaginal delivery as an alternative to vacuum or forceps

OdonAssistTM medical device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women will be able to participate in the ASSIST Ethiopia Study if all of the following apply at initial consent:
• ≥18 years of age;
• singleton pregnancy of at least 36 weeks' gestation,
• negative antenatal screen for HIV and Hepatitis B,
• in active labour and requiring an assisted vaginal birth for a clinical indication (as per local guidelines),
• the vertex is 1 cm or more below the ischial spines and there is no obstetric indication for an alternative method of AVB.

You may not qualify if:

• Women will not be able to take part in the ASSIST Ethiopia Study if:
• the fetal vertex is at or above the ischial spines,
• there is a diagnosis of a fetal skull abnormality (i.e. macrocephaly) or osteogenesis imperfecta,
• there is a suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia),
• there is an intrauterine fetal death in the current pregnancy,
• the woman is sensitive to latex,
• the woman is currently serving a prison sentence,
• there is a fetal bradycardia which is on-going and has not recovered.

Sponsors & Collaborators

• Doctors with Africa - CUAMM: lead
• Centre Hospitalier Universitaire de Besançon: collaborator
• St. Luke Catholic Hospital, Wolisso, Ethiopia: collaborator
• Fonds d'Innovation pour le Développement: collaborator

Study Sites (1)

St. Luke Catholic Hospital

Waliso, Ethiopia

Location

Related Publications (18)

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  PMID: 22959831 BACKGROUND

• Hotton EJ, Blencowe NS, Lenguerrand E, Draycott TJ, Crofts JF, Wade J. 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 Dec 15;11(12):e057023. doi: 10.1136/bmjopen-2021-057023.

  PMID: 34911726 BACKGROUND

• Sobhy S, Arroyo-Manzano D, Murugesu N, Karthikeyan G, Kumar V, Kaur I, Fernandez E, Gundabattula SR, Betran AP, Khan K, Zamora J, Thangaratinam S. Maternal and perinatal mortality and complications associated with caesarean section in low-income and middle-income countries: a systematic review and meta-analysis. Lancet. 2019 May 11;393(10184):1973-1982. doi: 10.1016/S0140-6736(18)32386-9. Epub 2019 Mar 28.

  PMID: 30929893 BACKGROUND

• Verma GL, Spalding JJ, Wilkinson MD, Hofmeyr GJ, Vannevel V, O'Mahony F. Instruments for assisted vaginal birth. Cochrane Database Syst Rev. 2021 Sep 24;9(9):CD005455. doi: 10.1002/14651858.CD005455.pub3.

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• Bahl R, Hotton E, Crofts J, Draycott T. Assisted vaginal birth in 21st century: current practice and new innovations. Am J Obstet Gynecol. 2024 Mar;230(3S):S917-S931. doi: 10.1016/j.ajog.2022.12.305. Epub 2023 Jul 28.

  PMID: 38462263 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bailey PE, van Roosmalen J, Mola G, Evans C, de Bernis L, Dao B. Assisted vaginal delivery in low and middle income countries: an overview. BJOG. 2017 Aug;124(9):1335-1344. doi: 10.1111/1471-0528.14477. Epub 2017 Jan 31.

  PMID: 28139878 BACKGROUND

• Nolens B, Capelle M, van Roosmalen J, Mola G, Byamugisha J, Lule J, Faye A, van den Akker T. Use of assisted vaginal birth to reduce unnecessary caesarean sections and improve maternal and perinatal outcomes. Lancet Glob Health. 2019 Apr;7(4):e408-e409. doi: 10.1016/S2214-109X(19)30043-9. No abstract available.

  PMID: 30879501 BACKGROUND

• Maheu-Giroux M, Filippi V, Samadoulougou S, Castro MC, Maulet N, Meda N, Kirakoya-Samadoulougou F. Prevalence of symptoms of vaginal fistula in 19 sub-Saharan Africa countries: a meta-analysis of national household survey data. Lancet Glob Health. 2015 May;3(5):e271-8. doi: 10.1016/S2214-109X(14)70348-1.

  PMID: 25889469 BACKGROUND

• Gedefaw G, Wondmieneh A, Getie A, Bimerew M, Demis A. Estimating the Prevalence and Risk Factors of Obstetric Fistula in Ethiopia: Results from Demographic and Health Survey. Int J Womens Health. 2021 Jul 7;13:683-690. doi: 10.2147/IJWH.S306221. eCollection 2021.

  PMID: 34262358 BACKGROUND

• Berhan Y, Berhan A. Causes of maternal mortality in Ethiopia: a significant decline in abortion related death. Ethiop J Health Sci. 2014 Sep;24 Suppl(0 Suppl):15-28. doi: 10.4314/ejhs.v24i0.3s.

  PMID: 25489180 BACKGROUND

• Ayenew AA. Incidence, causes, and maternofetal outcomes of obstructed labor in Ethiopia: systematic review and meta-analysis. Reprod Health. 2021 Mar 10;18(1):61. doi: 10.1186/s12978-021-01103-0.

  PMID: 33691736 BACKGROUND

• Addisu D, Mekie M, Melkie A, Yeshambel A. Burden of obstructed labor in ethiopia: A systematic review and meta-analysis. Midwifery. 2021 Apr;95:102930. doi: 10.1016/j.midw.2021.102930. Epub 2021 Feb 5.

  PMID: 33581417 BACKGROUND

• Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.

  PMID: 16581405 BACKGROUND

• Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1.

  PMID: 38462265 BACKGROUND

• Hotton EJ, Bale N, Rose C, White P, Wade J, Mottet N, Loose AJ, Elhodaiby M, Lenguerrand E, Draycott TJ, Crofts JF; ASSIST II Study Group. The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom). Am J Obstet Gynecol. 2024 Mar;230(3S):S932-S946.e3. doi: 10.1016/j.ajog.2023.05.018. Epub 2023 Jul 30.

  PMID: 38462264 BACKGROUND

• Hotton EJ, Lenguerrand E, Alvarez M, O'Brien S, Draycott TJ, Crofts JF; ASSIST Study Team. Outcomes of the novel Odon Device in indicated operative vaginal birth. Am J Obstet Gynecol. 2021 Jun;224(6):607.e1-607.e17. doi: 10.1016/j.ajog.2020.12.017. Epub 2020 Dec 13.

  PMID: 33316274 BACKGROUND

Study Officials

• Flavio Bobbio, MD

  Doctors with Africa - CUAMM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ASSIST Ethiopia Study is a feasibility study of women who require an assisted vaginal birth (AVB) for a recognized clinical indication in a low-resource setting. Early feasibility studies have reported success rates ranging from 50% to 80%. To ensure we obtain 10 quality assessments from both patients and healthcare providers, a sample size of 20 subjects is anticipated. This number accounts for potential data loss due to technical issues, patient dropouts, and variability in responses. The goal of this feasibility study is to obtain meaningful preliminary data of safety, efficacy and acceptability in a low-resourced setting, that are crucial to inform the implementation of the device within the African environment.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)