Related Experiment Video
Updated: Nov 16, 2025
08:49
External Cephalic Version: Is it an Effective and Safe Procedure?
Published on: June 6, 2020
15.4K
Perinatal outcome after vacuum assisted delivery with digital feedback on traction force; a randomised controlled
Stefhanie Romero1,2, Kristina Pettersson3,4, Khurram Yousaf5
1Pregnancy Care & Delivery K57, Karolinska University Hospital, 141 86, Stockholm, Sweden. stefhanie.romero@sll.se.
BMC Pregnancy and Childbirth
|February 27, 2021
Summary
A digital handle for vacuum assisted deliveries (VAD) did not reduce neonatal complications in this study. Further multicenter research is needed to confirm if this technology can improve safety and clinical training.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Medicine
- Medical Device Technology
Background:
- Low and mid station vacuum assisted deliveries (VAD) are subjective procedures linked to adverse neonatal outcomes.
- Limited advancements exist in VAD technical development, traction force control, and objective documentation.
- This study investigated a digital handle with haptic feedback to mitigate neonatal risks during VAD.
Purpose of the Study:
- To evaluate if a digital handle with instant haptic feedback reduces neonatal complications during low or mid-station VAD.
- To compare the incidence of adverse neonatal outcomes between conventional and digital VAD handles.
Main Methods:
- A two-center, randomized superiority trial conducted from 2016-2018.
- Participants were randomized to either a conventional or a digital handle attached to a Bird metal cup.
- The digital handle provided real-time traction force measurement and vibration alerts for excessive force.
- The primary outcome was a composite of hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, death, or subgaleal hematoma.
Main Results:
- A total of 567 vacuum extractions were randomized (296 digital, 271 conventional).
- The primary outcome incidence did not differ significantly between the digital (2.7%) and conventional (2.6%) handle groups.
- A significant difference in primary outcome incidence was observed between the two delivery wards (4% vs. 0.9%, p < 0.05).
- The study was underpowered, requiring 800 cases per group to detect a 3% to 1% reduction in primary outcome.
Conclusions:
- The study was underpowered due to a lower-than-estimated incidence of the primary outcome.
- Observed differences between delivery wards may indicate varying experience with the VAD equipment.
- Objective documentation via a digital handle is promising for improving VAD safety and training.
- A larger, multicenter study is necessary to conclusively demonstrate improved safety with digital VAD handles.
