Force Limiting Obstetric Forceps for Instrumental vagina Delivery.
Research type
Research Study
Full title
Force limiting obstetric forceps for instrumental vaginal delivery
IRAS ID
164689
Contact name
ALEXANDER OBOH
Contact email
Sponsor organisation
Hull and East Yorkshire Hospital NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The present day obstetric forceps used in assisted vagina delivery of babies are made from steel material and were introduced over a century ago. They are safe however the major drawback is the risk of trauma to baby and mother due to excessive traction force use by obstetricians and steel material of the device.
The Pro-Nata forceps is a newly designed obstetric forceps for assisted vaginal delivery (US patent No. 8,939,989). The Pro-Nata forceps unlike the tradition obstetrics forceps (made from steel material) is made from a glass-fibre reinforced polyarylamide compound. This has a high tensile strength and rigidity, outstanding surface gloss and excellent creep resistance. Polyarylamide compound is approved and used in medical devices.
The Pro-Nata forceps comprise a pair of blades for holding the head of a baby and a handle having one part by which a user can apply a pulling force on the head of the baby in use. The blades each have a superior rim and inferior rim wherein the greatest separation between the superior rims is greater than the greatest separation between the inferior rims when the obstetric forceps are in a closed configuration so that the blades adopt the form of an at least partially bowl shape.
The Pro-Nata forceps has a mechanically operated force indicator is connected to one part of the handle and is operable to provide a visual indication of the amount of pulling force being applied to the head of the baby when a user applies a pulling force on the head of the baby in use and wherein the force indicator is responsive to an increase only in the pulling force, and the force indicator automatically records the maximum pulling force applied. The Pro-Nata forceps is designed with a mechanically operated disabling device operable to at least partially disable the obstetric forceps when a maximum pulling force of 14 kg has been exceeded.
The Pro-Nata obstetric forceps has been used in laboratory trials using to effect vagina delivery. The laboratory trials were conducted using the PROMPT birthing simulator. The PROMPT birthing simulator is a recognised and validated training simulator for teaching and practising the skills required for successful vaginal delivery. It is also provided with a force monitoring device to provide feedback and graphical record of the force applied. In the laboratory trials, the Pro-Nata forceps device made from glass-fibre reinforced polyarylamide material offered good tensile strength comparable to the traditional steel blades. The PROMPT birth simulator force monitoring system was used to monitor and record the amount of traction force applied during delivery of the baby and this was corresponding to the force indicated on the Pro-Nata forceps during use.
The aim of this study is to determine the feasibility to complete a vaginal delivery using the Pro-Nata obstetric forceps. This study will ascertain what level of traction force may be safely applied to complete a delivery and to establish practical guidelines for forceps delivery in clinical practice.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0433
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion