A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N)

Connolly, Katherine A.; Kohari, Katherine; Rekawek, Patricia; Smilen, Brooke S.; Miller, Meredith; Moshier, Erin; Stone, Joanne; Bianco, Angela

doi:10.1016/j.ajog.2016.03.034

Cited by 40 publications

(42 citation statements)

References 16 publications

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“…The Foley balloon has been the gold standard method for decades. [16][17][18] After the findings of the A Randomized Trial of Induction Versus Expectant Management (ARRIVE) trial, 2 an increasing rate of labor induction is anticipated, emphasizing the importance of choosing induction methods that are safe, practical, and cost effective.…”

Section: Discussionmentioning

confidence: 99%

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

Saad

Villarreal

Eid

et al. 2019

American Journal of Obstetrics and Gynecology

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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-totreat 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, e2.7% 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 ¼ 204 in the Foley balloon, n ¼ 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 ¼ .01), relaxing time (P ¼ .001), and performance of desired daily activities (P ¼ .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.

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Section: Discussionmentioning

confidence: 99%

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

Saad

Villarreal

Eid

et al. 2019

American Journal of Obstetrics and Gynecology

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“…Six RCTs (total of 1,133 patients) were eligible for inclusion in this meta-analysis. [3][4][5][6][7][8] Details of included trials, methodological quality, bias risk assessment, and outcomes are summarized in ►Tables 1-4. While the compared interventions consisted of FB with or without oxytocin, the characteristics of the interventions differed among included studies.…”

Section: Resultsmentioning

confidence: 99%

“…While the compared interventions consisted of FB with or without oxytocin, the characteristics of the interventions differed among included studies. Four out the six trials 3,5,6,8 inflated the balloon to a final volume of 60 mL with normal saline, while El Khouly and Pettker et al used a volume of 30 mL. 4,7 The latter did not report whether the FB was placed or taped under tension.…”

Section: Resultsmentioning

confidence: 99%

“…4 By combining mechanical and pharmacologic methods, a synergistic effect may occur expediting the induction process and decreasing the need for CD. Some studies examining different combinations of induction methods generally support the synergistic effect, 3,5,6 while others do not. 4,7,8 Hence, the question as to whether to combine mechanical and pharmacological methods of cervical ripening remains unanswered.…”

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confidence: 99%

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Cervical Ripening Using Foley Balloon with or without Oxytocin: A Systematic Review and Meta-Analysis

et al. 2018

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“…40,41 However, recent data suggest that with the application of Foley catheter plus oxytocin or prostaglandins an increased number of deliveries in first 24hours is achieved. [42][43][44] Regarding perinatal outcomes and related to spontaneous labour, IOL is associated with more maternal complications and worse perinatal results 45 with independence of the method used Duro-Gómez J. 46 Finally, for favourable Bishop (≥ 6) early amniotomy prior to oxytocin stimulation reduces the interval to delivery.…”

Section: How Can Induction Of Labour Be Done?mentioning

confidence: 99%

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2017

IPCB

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According to WHO, 25% of all deliveries are induced in developed countries. There are many controversies and multiple guides to induction of labour (IOL) are used in different hospitals. There are social or maternofetal indications to IOL. The way to perform the IOL depends on cervical status. Currently, prostaglandins are considered the most effective method to IOL (delivery before 24hours). Depends on each patient, it is recommended misoprostol or dinoprostone. For cases with contraindications for prostaglandins, mechanical methods (Foley catheter or double balloon intracervical catheter) are good alternatives. In any case, some special circumstances (twins' pregnancies, women with previous caesarean…) must been considered. According to perinatal outcomes, both methods are similar. Although prostaglandins are more costeffective method, women are most satisfied with mechanical methods.

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A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N)

Cited by 40 publications

References 16 publications

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

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

Cervical Ripening Using Foley Balloon with or without Oxytocin: A Systematic Review and Meta-Analysis

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