A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial)

Antonio Saad, Josephine Villarreal, Joe Eid, Nicholas Spencer, Viviana Ellis, Gary Hankins, George Saade

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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/m 2 . 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.

Original languageEnglish (US)
Pages (from-to)275.e1-275.e9
JournalAmerican journal of obstetrics and gynecology
Volume220
Issue number3
DOIs
StatePublished - Mar 1 2019

Fingerprint

Cervical Ripening
Randomized Controlled Trials
Cervix Uteri
Nonoxynol
dilapan
Drug Approval
United States Food and Drug Administration
Random Allocation
Parity
Patient Satisfaction
Sample Size
Pregnant Women
Dilatation
Sleep
Body Mass Index
Mothers

Keywords

  • cervical ripening
  • Dilapan-S
  • induction
  • labor
  • mechanical

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). / Saad, Antonio; Villarreal, Josephine; Eid, Joe; Spencer, Nicholas; Ellis, Viviana; Hankins, Gary; Saade, George.

In: American journal of obstetrics and gynecology, Vol. 220, No. 3, 01.03.2019, p. 275.e1-275.e9.

Research output: Contribution to journalArticle

Saad, Antonio ; Villarreal, Josephine ; Eid, Joe ; Spencer, Nicholas ; Ellis, Viviana ; Hankins, Gary ; Saade, George. / A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). In: American journal of obstetrics and gynecology. 2019 ; Vol. 220, No. 3. pp. 275.e1-275.e9.
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