Clinical outcomes following implementation of an operative vaginal birth safety bundle: A prospective observational study and time-series analysis.

Abstract

BACKGROUND Poor outcomes from operative vaginal birth are associated with failure to recognize malposition, lack of interdisciplinary communication and deviation from accepted guidelines. We implemented a safety bundle including routine intrapartum ultrasound, a structured time-out and procedural checklist, birth experience survey, and a postnatal debrief pathway. OBJECTIVES To compare clinical outcomes from operative vaginal birth before and after the implementation of a safety bundle at Monash Health, Melbourne, Australia. STUDY DESIGN We compared clinical outcomes pre- versus post-bundle implementation for all women having an operative vaginal birth or fully-dilated cesarean of a term singleton cephalic non-anomalous fetus at Monash Health. Data were prospectively collected following bundle implementation from August 2022 to August 2024 and compared to a historical control cohort from November 2019 to November 2021, before the initial pilot of the bundle. We performed an interrupted time-series analysis to assess change in outcome trends over time. The primary outcome was a composite of neonatal morbidity, including Apgar score <7 at five minutes, cord lactate >8mmol/L, significant birth trauma, intubation or cardiac compressions, therapeutic cooling, and neonatal intensive care unit admission. RESULTS We included 2,427 and 2,914 births meeting the inclusion criteria in the post- and pre-bundle periods, respectively. Following bundle implementation, mothers were older (30.5 ± 4.8 vs. 30.1 ± 4.9, p=.006), at a slightly later gestational age (39.5 [38.7, 40.3] vs. 39.4 [38.5, 40.2], p=.003), it was more common for specialist obstetricians to attend the birth (56.1% vs. 47.7%, p<.001), for ultrasound to be performed (55.8% vs. 5.0%, p<.001) and for vaginal station to be low (54.1% vs. 49.4%, p=.001), whilst it was less common to have occiput anterior position (71.2% vs. 74.4%, p=.03) or missing documentation of clinical assessment (0.8% vs. 3.4%, p<.001). There were no significant differences in rates of forceps, vacuum, or fully-dilated cesarean overall; however, following implementation there were more cesareans without attempted OVB (9.5% vs. 7.8%, p=.03), fewer births with ≥four tractions or ≥two cup detachments (5.8% vs. 8.5%, p<.001) and less unsuccessful OVB (6.3% vs. 8.3%, p=.005). There were no significant differences in the pre-defined neonatal composite morbidity (14.2% vs. 13.9%, p=.80); however, there were significantly fewer neonates delivered in an unexpected position (0.7% vs. 2.8%, p<.001), lower rates of severe neonatal birth trauma (1.3% vs. 2.5%, p<.001) and lower rates of neonatal intensive care admissions (1.8% vs. 2.7%, p=.02). There were higher rates of postpartum hemorrhage >1000 mL (17.6% vs. 15.2%, p=0.02), but no differences in blood transfusions (3.7% vs. 3.8%, p=0.96) or obstetrical anal sphincter injury (4.8% vs. 5.4%, p=0.38). Interrupted time-series analysis demonstrated significant step reductions in fully-dilated cesarean (-5.9%, 95%CI -11.77 to -0.11, p=.05), unsuccessful OVB attempt (-5.1%, 95%CI -8.74 to -1.37, p=.008) and cesarean for unsuccessful OVB (-2.4%, 95%CI -4.48 to -0.31, p=0.03), with no significant difference neonatal or maternal morbidity. CONCLUSIONS Implementation of a safety bundle for OVB reduced the rates of unsuccessful OVB and may reduce rates of neonatal birth trauma and neonatal intensive care admissions.