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Odon Device for Instrumental Vaginal Deliveries: Results of a Medical Device Pilot Clinical Study Javier A

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Odon Device for Instrumental Vaginal Deliveries: Results of a Medical Device Pilot Clinical Study Javier A Schvartzman et al. Reproductive Health (2018) 15:45 https://doi.org/10.1186/s12978-018-0485-8 RESEARCH Open Access Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study Javier A. Schvartzman1, Hugo Krupitzki1, Mario Merialdi2,3, Ana Pilar Betrán2, Jennifer Requejo4, My Huong Nguyen2, Effy Vayena5, Angel E. Fiorillo1, Enrique C. Gadow1, Francisco M. Vizcaino1, Felicitas von Petery1, Victoria Marroquin1, María Luisa Cafferata6, Agustina Mazzoni6, Valerie Vannevel7, Robert C. Pattinson7, A Metin Gülmezoglu2, Fernando Althabe6, Mercedes Bonet2* and for the World Health Organization Odon Device Research Group Abstract Background: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Methods: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Results: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Conclusions: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. Trial registration: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered. Keywords: Instrumental vaginal delivery, Odon device, Second stage of labour * Correspondence: [email protected] 2UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211 Geneva 27, Switzerland Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Schvartzman et al. Reproductive Health (2018) 15:45 Page 2 of 10 Plain English summary vacuum extractor at around 20% [8]. An additional bar- The Odon device is an innovation, presently under de- rier is the high level of skill and continuous training re- velopment, intended to assist vaginal birth when second quired to perform safe and effective IVD [9, 10]. This stage takes longer than what is considered safe or if limits the use of IVD if birth attendants are not provided complications arose (e.g. baby is large or distressed). The with sufficient resources to obtain and maintain the ne- objective of the study was to find out whether this new cessary skills. device helps pushing out of the baby through the birth The design and development of innovative IVD instru- canal. The study included women at their first delivery ments that are safe for mothers and babies, easy for and women who delivered before, with uncomplicated different cadres of skilled birth attendants to use, cost- pregnancies and one fetus in two hospitals in Argentina effective, and affordable in low resource settings is a and South Africa. Delivery with the Odon device was priority [11]. In this sense, the Odon device is a techno- attempted in women undergoing normal, uncomplicated logical innovation intended to fulfil this gap, by improv- labour. The Odon device was inserted successfully in 46 ing outcomes associated with prolonged or complicated of the 49 women included (93%), and successful delivery second stage of labour and reduce the skill level and with expulsion of the fetal head after one-time applica- equipment required to perform assisted vaginal tion of the Odon device was achieved in 35 (71%) deliveries. women. Genital tears occurred in 29 (59%) women. As We present results of an early terminated study de- the use in humans has been limited, increased risk of signed to evaluate the feasibility and preliminary safety tears and other unknown risks cannot be ruled out. Four of delivery with early prototypes of the Odon device in women had cervical tears but no women had severe singleton term pregnancies under non-emergency perineal trauma. All babies were born alive and vigorous. conditions. No adverse maternal or infant outcomes were observed at 6-weeks follow-up, and at 1 year for the first 30 Methods mothers and babies. Delivery using the Odon device is Study design and participants feasible. These findings suggest continuing evaluating This was a hospital-based, multi-phased, open-label, med- the effectiveness and safety of new prototypes of the BD ical device pilot clinical study without control group. The Odon Device™ in a clinical comparative trial with a study methods were described in detail elsewhere [12]. standard device before introduction in clinical practice. The design of the study in phases included an evalu- ation of the first five multiparous women, the next 25 Background multiparous with 1 year follow-up, and then the inclu- Prolonged or complicated second stage of labour is asso- sion of both multiparous and nulliparous women until ciated with potentially serious maternal complications completion of the sample size. Therefore, women were and deaths as well as stillbirths and neonatal morbidity enrolled in three phases: 1) multiparous women with a and mortality [1]. previously successful spontaneous vaginal delivery with Currently, the main options for managing prolonged/ 1 year follow up (2011-2012); 2) multiparous and complicated second stage of labour are instrumental va- nulliparous with 6-weeks follow up (2014-2015) at a pri- ginal delivery (IVD) with forceps or vacuum extractor, vate not-for-profit tertiary hospital in Buenos Aires, and caesarean section. IVD is one of the six critical func- Argentina. In 2013, Becton Dickinson and Company tions of basic emergency obstetric and neonatal care [2], (BD) licensed the development rights of the Odon de- but currently under-used, particularly in low-resource vice. In consequence, the trial was paused in January settings where rates are as low as 1-5% [3, 4]. In high- 2015 for BD to conduct preclinical studies [13–15] and resource settings, IVD rates tend to be higher (up to develop a new prototype. 3) The third phase included 15%) [5, 6], but declining rates have been reported in multiparous and nulliparous women with follow-up until several countries [4]. These trends are inversely corre- discharge at a public tertiary hospital in Pretoria, South lated with the increasing rates of caesarean sections Africa (2017). The new BD Odon device was planned to worldwide [7]. be applied in additional women at public hospitals in There are multiple factors associated with low or de- Argentina (2 hospitals), Kenya (1) and South Africa (4) clining use of IVD. None of the available instruments for completion of the sample size, before the study was are without risk for the mother or the baby. While use prematurely terminated. After the 49th case, the com- of forceps is associated with increased maternal perineal pany decided to end this pilot study in favour of a ran- trauma, need for analgesia and neonatal facial injury, domized pivotal clinical trial to be conducted in Europe cephalhaematoma and subgaleal haemorrhage are asso- and India. ciated with vacuum birth [8]. Failure rates are also re- Women were invited to participate if they were be- ported to be relatively high, particularly with the use of tween 18 and 35 years old, had no pre-existing health Schvartzman et al. Reproductive Health (2018) 15:45 Page 3 of 10 conditions and uncomplicated singleton pregnancies in the third trimester in Argentina or while in the hospital admitted for induction of labour in South Africa. Written informed consent was obtained before labour during antenatal care in Argentina or at the hospital after admission for childbirth in South Africa. Women were eligible for application of the Odon device during the second stage if the following conditions were met: fetus was alive and had a normal fetal heart rate as assessed by continuous electronic fetal monitoring; fully dilated cervix; ruptured membranes; any anterior occiput position; station level equivalent to 2 cm or more below the spines (station + 2 or lower). Fig. 1 The Odon Device. Reproduced with permission of Schvartzman et al. Reproductive Health 2013, 10:33 Women were excluded if they did not confirm consent to participate in the study verbally before application of external fold in contact with the vaginal wall. The sleeve the device, or if any maternal or fetal complication arose contains an air chamber (cuff) that is inflated around during labour.
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