Outpatient Foley Catheter for Induction of Labor in Nulliparous Women

Abstract

OBJECTIVE: To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery. METHODS: We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours. RESULTS: From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3–7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4–15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4–1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8–3.9, P=.16) were not significantly different between groups. CONCLUSION: In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery. CLINCAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03472937.

Outpatient Cervical Ripening with Balloon Catheters

“…Data on route of delivery were available for all eight RCTs (Chen V, Sheehan P. Aust N Zeal J Obstet Gynaecol 2019;59:39-40. doi: 10.1111/ajo.13067). [9][10][11][12][13][14][15] The outpatient group was significantly less likely than the inpatient group to undergo cesarean delivery (21% vs 27%), with a RR of 0.76 (95% CI 0.59-0.98). The RR of cesarean delivery remained significantly lower in the outpatient group when excluding unpublished studies (Chen V, Sheehan P. Aust N Zeal J Obstet Gynaecol 2019;59:39-40. doi: 10.1111/ajo.13067) 15 (RR 0.76, 95% CI 0.58-0.99, n5651) and when including only studies of low risk of bias (RR 0.71, 95% CI 0.53-0.95, n5496).…”

“…Based on this, we could expect findings that compared outpatient balloon to inpatient balloon plus misoprostol to be similar to our findings, but more research, in the form of RCTs, is needed. Study protocols also differed in their use of Ausbeck 2020 13 Haavisto 2020 14 Rahman 2020 15 Foley or Cook catheters, and the inflation volumes. All studies but one 14 followed intention-to-treat analysis.…”

Out-of-Hospital Cervical Ripening With a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States—A Cost-Consequence Analysis

“…Few FDA-indicated cervical ripening methods are available with a safety profile suitable for use outside of the hospital setting. It has been suggested that mechanical methods may be most suited to facilitate outpatient cervical ripening (30,35,36). In comparison to the balloon catheter, Saad et al found that the synthetic hygroscopic cervical dilator allowed for a statistically significant increase in the number of women able to perform their daily activities, and their ability to get some relaxation time and sleep (24).…”

“…With the ongoing COVID-19 pandemic, there is an additional incentive to reduce the burden on hospital resourcesand to safely keep patients out of the hospital. Furthermore, publishing on outpatient cervical ripening increased dramatically in 2020 showing a global increase in interest (7,8,16,(35)(36)(37)(38)(39).…”

Office-based ambulatory cervical ripening prior to inpatient induction of labor

“…Ausbeck and colleagues randomly assigned 126 nulliparous women with a Bishop score <5, at a gestational age ranging from 39 weeks and 0 days through 41 weeks and 6 days, to outpatient overnight CR or inpatient CR with a transcervical Foley catheter. 2 Breech presentation and multiple gestation pregnancies were excluded from the study. The investigators utilized a 16 French Foley catheter and filled the balloon with 30 mL of sterile water.…”