Abstract
Objective
Instruments used in assisted vaginal birth have seen little innovation for decades.
Due to the risk of trauma and technical difficulty incurred during forceps delivery,
instrumental deliveries are on a decline, and the global rate of primary cesarean
birth is rising. The novel Paily Obstetric Forceps (POF) features a compact, lighter
design with thinner blades, designed to increase operator comfort and minimize maternal
and neonatal injuries. We aim to determine the feasibility and safety of POF in achieving
vaginal birth compared to a ventouse device with a 50 mm silastic cup.
Study Design
We conducted a single-blinded, parallel arm, randomized clinical trial of the novel
POF vs a ventouse device, in patients undergoing indicated assisted vaginal birth,
at a tertiary care obstetric unit. We randomized 100 patients to be allocated on a
1:1 ratio to both intervention arms. Primary outcome was the proportion of successful
instrumental deliveries. Secondary outcomes were the number of pulls required during
traction and any maternal or neonatal adverse events.
Results
The POF was significantly more successful in achieving vaginal birth than the ventouse
device (n = 50/50, 100 % vs n = 42/50, 84 %, p = 0.006). Operators reported requiring
significantly fewer pulls during POF traction than ventouse. POF demonstrated a higher
risk for maternal trauma (RR = 3.2, 95 % CI = 1.5 to 6.9, NNH = 2.7) but a lower risk
for neonatal injury (RR = 0.6, 95 % CI = 0.3 to 1, NNH = 5.7). Maternal and neonatal
recovery durations were comparable. There were no incidences of maternal or neonatal
mortality.
Conclusion
The POF can be used in indicated assisted vaginal birth with superior success rates
and better neonatal outcomes than ventouse. Other obstetric forceps must be standardized
to conduct larger superiority trials of forceps designs.
Abbreviations:
OB-GYN (Obstetrics and Gynecology), POF (Paily Obstetric Forceps), ITT (Intention-to-treat), PP (Per-Protocol), AT (As-Treated), RR (Relative Risk), CI (Confidence Interval), NNH (Number-Needed-To-Harm), CONSORT (Consolidated Standards of Reporting Trials)Keywords
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Biography
Prof. VP Paily, MD, FRCOG is a senior obstetrician-gynecologist and the head of the department at Rajagiri Hospital, Kerala, India. His efforts initiated the Confidential Review of Maternal Deaths, Kerala State, India – and has served as its state coordinator since its inception in 2004. His inventions include the transvaginal uterine artery clamp for arresting post-partum hemorrhage, the Paily aorta/common iliac clamp for minimizing blood loss during Placenta Accreta Spectrum procedures, the Paily obstetric forceps for operative vaginal delivery and as well as other instruments that simplify vaginal surgery. He has authored several textbooks, with a focus on tackling obstetric emergencies. He has served as a founding member and later, President of the Kerala Federation of Obstetrics and Gynecology.
Article info
Publication history
Published online: November 05, 2022
Accepted:
October 30,
2022
Received in revised form:
October 8,
2022
Received:
July 21,
2022
Identification
Copyright
© 2022 Elsevier B.V. All rights reserved.
