RCT Results: Does Early AROM Following Foley Expulsion Reduce Time to Delivery?
BACKGROUND AND PURPOSE:
Gomez Slagle et al. (AJOG, 2022) evaluated whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term
Randomized clinical trial
Undergoing Foley catheter and misoprostol induction at ≥37 weeks
Early artificial rupture of membranes
Amniotomy within 1 hour of Foley catheter expulsion
Adjustments: Age | BMI | Parity | Mode of delivery | Bishop score
Interaction between randomization group and parity also analyzed
Power 80% | Assuming 10% drop out, 160 patients to detect a 4-hour reduction in delivery time
Time to delivery: Time from Foley catheter expulsion to delivery
Early artificial rupture: 79 participants | Expectant management: 81 participants
Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (P<0.001)
Early artificial rupture of membranes: 11.1 hours (IQR, 6.25 to 17.1)
Expectant management: 19.8 hours (IQR, 13.2 to 26.2)
In addition, a greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (P=0.03)
Early artificial rupture of membranes: 86%
Expectant management: 70%
There was no difference in the cesarean delivery rate between the 2 groups (P=0.25)
Early artificial rupture of membranes: 22%
Expectant management: 31%
Individuals delivered 2.3 times faster following early artificial rupture of membranes
Hazard ratio 2.3 (95% CI, 1.5 to 3.4); P<0.001
There were no significant differences in maternal or neonatal outcomes
For women undergoing induction of labor, early artificial rupture of membranes within 1 hour of Foley catheter expulsion led to a 2.3 times faster time-to-delivery
Study limitation includes lack of blinding
However, time-to-delivery is an objective primary outcome measure
The authors state
Therefore, amniotomy within 1 hour of Foley catheter expulsion may be considered among individuals undergoing a combined pharmacologic and mechanical induction at term
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