The ASSIST II Study is currently on-hold due to Covid-19, but we’re hoping to be able to restart over the summer if it is safe to do so. When we are able to restart, we’ll post some study information here, including a video explaining the study and demonstrating the BD Odon Device, as well as more detailed information about what taking part in the study involves. If you would like to know more in the meantime please email: firstname.lastname@example.org
Around one in eight women in the UK require assistance to give birth to their baby vaginally. Currently, doctors use either forceps or a ventouse (a suction cup) to help women have their babies in this manner. This is known as an assisted vaginal birth (AVB). Most mothers and babies do very well after an AVB, and the procedure is usually much better for both mothers and babies than the alternative, an emergency Caesarean section.
However, women and their babies can sometimes be harmed by an AVB. Mothers have a greater tendency to have severe tears of the vagina, and, sometimes, the rectum (back passage) compared to a spontaneous vaginal birth. Mothers may have more pain while healing (usually for one to two weeks) following a birth that has been assisted by forceps or ventouse. Babies may develop bruising over the scalp or face where the forceps or ventouse have been applied. Babies can also, very rarely (around 1 in 1000), sustain more serious harm, such as nerve injuries or bleeding into the brain or eye. Therefore, although AVB is generally very safe and usually better than the alternative (an emergency caesarean section), it is sensible to try to improve the technique to assist a vaginal birth and reduce the risks to both mothers and their babies. Unfortunately, no new types of devices to assist vaginal birth have been introduced into practice since the ventouse in the 1950s.
The BD Odon Device is a new device for AVB that has been designed by a team of midwives, doctors and engineers. The BD Odon Device works by placing a cuff of air which is attached to a sleeve, around the baby’s head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.
Following on from the ASSIST Study which was conducted between October 2018 and January 2019, ASSIST II is a second intrapartum study in which we would like to use the BD Odon Device to help women give birth in cases where it is necessary to assist the birth of their baby. Our study will evaluate the safety and effectiveness of the BD Odon device and seek the views of women and healthcare professionals on its use. The information gained from the study will be used to plan a large comparative study.