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.
