A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial)
Copyright © 2019 Elsevier Inc. All rights reserved..
OBJECTIVE: The objective of the study was to test the hypothesis that Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term.
STUDY DESIGN: Pregnant women ≥37 weeks scheduled for induction with unfavorable cervix (≤3 cm dilated and ≤60% effaced) were randomly assigned to 12 hours of either Foley balloon inflated with 60 mL saline or Dilapan-S for cervical ripening. If the cervix remained unfavorable, then 1 more round of the assigned dilator was used. Management following ripening was left up to the clinical providers. The primary outcome was vaginal delivery. A satisfaction survey was also obtained after the preinduction period. Sample size was based on a noninferiority margin of 10%, 90% power, and an estimated frequency of vaginal delivery of 71% in Foley balloon and 76% in Dilapan-S.
RESULTS: From November 2016 through February 2018, 419 women were randomized (209 to Foley balloon; 210 to Dilapan-S). In the intent-to-treat analysis, vaginal delivery was more common in Dilapan-S vs Foley balloon (81.3% vs 76.1%), with an absolute difference with respect to the Foley balloon of 5.2% (95% confidence interval, -2.7% to 13.0%) indicating noninferiority for the prespecified margin. The difference was not large enough to show superiority. Noninferiority was confirmed in the per-protocol population (n = 204 in the Foley balloon, n = 188 in Dilapan-S), supporting the robustness of the results. Secondary outcomes were not different between groups, except for a longer time the device remained in place in Dilapan-S compared with the Foley balloon. Maternal and neonatal adverse events were not significantly different between groups. A priori interaction analyses showed no difference in the effect on vaginal delivery by cervical dilation at randomization, parity, or body mass index >30 kg/m2. Patients with Dilapan-S were more satisfied than patients with the Foley balloon as far as sleep (P = .01), relaxing time (P = .001), and performance of desired daily activities (P = .001).
CONCLUSION: Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. Advantages of Dilapan-S over Foley include Food and Drug Administration approval, safe profile, no protrusion from the introitus, no need to keep under tension, and better patient satisfaction.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:220 |
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| Enthalten in: |
American journal of obstetrics and gynecology - 220(2019), 3 vom: 01. März, Seite 275.e1-275.e9 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Saad, Antonio F [VerfasserIn] |
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| Links: |
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| Themen: |
123535-69-3 |
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| Anmerkungen: |
Date Completed 19.11.2019 Date Revised 10.12.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ajog.2019.01.008 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM29415597X |
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| 100 | 1 | |a Saad, Antonio F |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial) |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 19.11.2019 | ||
| 500 | |a Date Revised 10.12.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2019 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: The objective of the study was to test the hypothesis that Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term | ||
| 520 | |a STUDY DESIGN: Pregnant women ≥37 weeks scheduled for induction with unfavorable cervix (≤3 cm dilated and ≤60% effaced) were randomly assigned to 12 hours of either Foley balloon inflated with 60 mL saline or Dilapan-S for cervical ripening. If the cervix remained unfavorable, then 1 more round of the assigned dilator was used. Management following ripening was left up to the clinical providers. The primary outcome was vaginal delivery. A satisfaction survey was also obtained after the preinduction period. Sample size was based on a noninferiority margin of 10%, 90% power, and an estimated frequency of vaginal delivery of 71% in Foley balloon and 76% in Dilapan-S | ||
| 520 | |a RESULTS: From November 2016 through February 2018, 419 women were randomized (209 to Foley balloon; 210 to Dilapan-S). In the intent-to-treat analysis, vaginal delivery was more common in Dilapan-S vs Foley balloon (81.3% vs 76.1%), with an absolute difference with respect to the Foley balloon of 5.2% (95% confidence interval, -2.7% to 13.0%) indicating noninferiority for the prespecified margin. The difference was not large enough to show superiority. Noninferiority was confirmed in the per-protocol population (n = 204 in the Foley balloon, n = 188 in Dilapan-S), supporting the robustness of the results. Secondary outcomes were not different between groups, except for a longer time the device remained in place in Dilapan-S compared with the Foley balloon. Maternal and neonatal adverse events were not significantly different between groups. A priori interaction analyses showed no difference in the effect on vaginal delivery by cervical dilation at randomization, parity, or body mass index >30 kg/m2. Patients with Dilapan-S were more satisfied than patients with the Foley balloon as far as sleep (P = .01), relaxing time (P = .001), and performance of desired daily activities (P = .001) | ||
| 520 | |a CONCLUSION: Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. Advantages of Dilapan-S over Foley include Food and Drug Administration approval, safe profile, no protrusion from the introitus, no need to keep under tension, and better patient satisfaction | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Dilapan-S | |
| 650 | 4 | |a cervical ripening | |
| 650 | 4 | |a induction | |
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| 700 | 1 | |a Ellis, Viviana |e verfasserin |4 aut | |
| 700 | 1 | |a Hankins, Gary D |e verfasserin |4 aut | |
| 700 | 1 | |a Saade, George R |e verfasserin |4 aut | |
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