Clinical outcomes following implementation of an operative vaginal birth safety bundle: a prospective observational...

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.

To compare clinical outcomes from operative vaginal birth before and after the implementation of a safety bundle at Monash Health, Melbourne, Australia.

We compared clinical outcomes prebundle vs postbundle implementation for all women having an operative vaginal birth or fully dilated cesarean of a term singleton cephalic nonanomalous 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 5 minutes, cord lactate >8 mmol/L, severe birth trauma, intubation or cardiac compressions, therapeutic cooling, and neonatal intensive care unit admission.

We included 2427 and 2914 births meeting the inclusion criteria in the postbundle and prebundle 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), while 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 operative vaginal birth (9.5% vs 7.8%, P=.03), fewer births with ≥4 tractions or ≥2 cup detachments (5.8% vs 8.5%, P<.001), and less unsuccessful operative vaginal births (6.3% vs 8.3%, P=.005). There were no significant differences in the predefined 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 unit 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% confidence interval, -11.77 to 0.11; P=.05), unsuccessful operative vaginal birth attempt (-5.1%; 95% confidence interval, -8.74 to 1.37; P=.008), and cesarean for unsuccessful operative vaginal birth (-2.4%; 95% confidence interval, -4.48 to 0.31; P=0.03), with no significant difference in neonatal or maternal morbidity.

Implementation of a safety bundle for operative vaginal birth reduced the rates of unsuccessful operative vaginal birth and may reduce rates of neonatal birth trauma and neonatal intensive care unit admissions.