The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study

Abstract

Background: Assisted vaginal birth is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for assisted vaginal birth (forceps and ventouse) are often not utilised in settings where there is most clinical need, resulting in maternal and neonatal morbidity and mortality which could have been prevented. The BD Odon Device is a new device for assisted vaginal birth which may be able to address this unmet need. However, before dissemination the device requires evaluation in robust clinical trials. A feasibility study to investigate the clinical impact, safety and acceptability of the BD Odon Device for assisted vaginal birth is therefore planned. This will provide further information on acceptability, recruitment and the outcome data required to design a future randomised controlled trial of the BD Odon Device versus Kiwi ventouse. Methods: Forty women who require an assisted vaginal birth for a recognised clinical indication will have the birth assisted with the BD Odon Device. The primary outcome is successful vaginal birth completed with the BD Odon Device. Secondary clinical outcomes include maternal and neonatal outcomes, and maternal and practitioner satisfaction. Safety data will be reviewed following every birth. Discussion: A future randomised controlled trial (RCT) of the BD Odon Device versus current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the RCT design. Trial registration: ISRCTN registration: ISRCTN10203171 (prospectively registered 27/07/2018). Keywords: BD Odon Device, forceps, ventouse, assisted birth, birth, intrapartum research

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review

“…One of these provided further detail about adherence, but none provided additional information about intervention descriptions, standardization or expertise. The only feasibility study referenced earlier preliminary research and had a published protocol [ 2 ].…”

“…These tapes were made available to the DSMB for safety evaluation purposes.’ However, no clarification was provided about who analysed the videos and the standards to which they were assessed [ 32 ]. The final paper of the Odon Device provided details of adherence in its published protocol; ‘an integrated qualitative study…will investigate: the practitioners’ use of the device to ensure that an appropriate training package is developed for trial; enable to intervention to be described and refined to optimise its use….’ [ 2 ]…”

“….' [2] Of the 37 papers with more than one trial group, 26 (71%) stated the number of women crossing over to another group. In a further eight (22%), it was unclear whether crossovers had occurred and in the remaining three (8%) there was no mention of crossovers.…”

“…Assisted vaginal birth (AVB) is an invasive procedure that, in skilled hands, can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour [ 1 ]. Typically, AVB involves the use of devices such as forceps or ventouse and, more recently, new devices [ 2 ]. Well-designed randomised controlled trials (RCTs) are essential for assessing the effectiveness of invasive procedures such as AVB, thereby enabling clinicians to make evidence-based decisions about whether to introduce them in routine practice.…”

Cephalic marks and well‐being in newborns after operative vaginal delivery

“…In case of inevitable operative delivery, strategies must be developed to prevent the occurrence of neonatal cephalic marks. Innovations like the Odon device that are currently being assessed in ongoing prospective studies may be as effective as, and less traumatic than, conventional instruments 23,24 …”