In:
Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 136, No. 3 ( 2020-09), p. 597-606
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
0029-7844
DOI:
10.1097/AOG.0000000000004041
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2020
detail.hit.zdb_id:
2012791-1
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