Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial

Forgie, Marie M; Greer, Danielle M.; Kram, Jessica J. F.; Wyst, Kiley B. Vander; Salvo, Nicole; Siddiqui, Danish

doi:10.1016/j.ajog.2015.12.043

Cited by 11 publications

(9 citation statements)

References 14 publications

(12 reference statements)

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“…In total, 138 studies were excluded (see Characteristics of excluded studies), 74 studies (102 reports) in this update. In this update, most of the excluded trials (54 studies) made comparisons not within the scope of this review (Ahmad 2015; Arsenijevic 2012; Arshad 2016; Caughey 2007; Connolly 2016; Connolly 2017; Demirel 2015; Edwards 2017; El‐Khayat 2016; El Sharkwy 2017; Forgie 2016; Forooshani 2011; Fruhman 2017; Gadel 2015; Ghanaei 2009; Ghanaie 2013; Gibson 2013; Gu 2015; Haghighi 2015; Hallak 2008; He 2000; Hill 2013; Hussein 2012; Ifnan 2006; Jonsson 2011; Kehl 2012; Kehl 2015; Lam 2006; Leong 2017; Levine 2016; Lutgendorf 2012; Manish 2016; Mattingly 2015; McGee 2016; Mei‐Dan 2012a; Mei‐Dan 2014; Movahed 2016; Mullin 2014; Neethurani 2013; Rameez 2007; Rezk 2014; Saad 2016; Salmeen 2012; Sandberg 2017; Schoen 2017; Sharma 2015a; Sharma 2017; Siddiqui 2013; Torbenson 2015;Walfisch 2015; Wickramasinghe 2014; Wilkinson 2015; Yaddehige 2015; Zakaria 2017). Four studies were not randomised trials (Du 2015; Miller 2015; Naseem 2007;…”

Section: Resultsmentioning

confidence: 99%

“…women could choose induction methodEdwards 2017Foley + PGE2 vs Foley => not within scope of reviewEl Sharkwy 2017Foley + miso vs Foley (and miso after 12 hours) => not within scope of reviewEl‐Khayat 2016Foley + isorbide mononitrate vs misoprostol => not within scope of reviewEl‐Torkey 1995Foley + EASI vs Foley => not in scopeEmery 1988No information.EUCTR 2012Trial registration, expected end date expired > 2 years. no information obtained (authors were contacted)Filshie 1992Insufficient information.Forgie 2016Placement stylette vs no stylette => not within scope of reviewForooshani 2011Foley vs laminaria => not within scope of reviewFruhman 2017Tension vs no tension => not within scope of reviewGadel 2015Cervical ripening in case of stillbirthGarebedian 2016Foley vs expectative managementGhanaei 2009Foley + oxytocin vs EASI + oxytocinGhanaie 2013Foley +oxytocin vs EASI + oxytocin vs PGE2 + oxytocin => not within scope of reviewGibson 2013different kind of traction applied => not within scope of reviewGilson 1996Dilapan vs no treatment => not in scopeGonsoulin 1989No clinical outcome reported.Gower 1982Laminaria vs placebo => not in scopeGreybush 2001High‐dose misoprostolGu 2015Low‐ vs high‐volume balloon => not within scope of reviewGuinn 2004Compares 2 mechanical regimens.Haghighi 2015EASI vs isoniazide => not within scope of reviewHallak 2008Foley vs Foley + EASI vs ATAD + EASI => not in scopeHe 2000Air v...…”

Section: Characteristics Of Excluded Studies [Ordered By Study Id]mentioning

confidence: 99%

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Mechanical methods for induction of labour

Vaan

Eikelder

Jozwiak

et al. 2019

Cochrane Database of Systematic Reviews

100

117

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BackgroundMechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.ObjectivesTo determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low‐dose misoprostol (oral and vaginal), amniotomy or oxytocin.Search methodsFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, , the WHO International Clinical Trials Registry Platform (), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.Selection criteriaClinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra‐amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra‐amniotic space (EASI).This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.Data collection and analysisTwo review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.Main resultsThis review update includes a total of 113 trials (22,373 women) contributing data to 21 comparisons. Risk of bias of trials varied. Overall, the evidence was graded from very‐low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (average risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; I² = 79%; low‐quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate‐quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 ...

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Section: Resultsmentioning

confidence: 99%

Section: Characteristics Of Excluded Studies [Ordered By Study Id]mentioning

confidence: 99%

Mechanical methods for induction of labour

Vaan

Eikelder

Jozwiak

et al. 2019

Cochrane Database of Systematic Reviews

100

117

View full text Add to dashboard Cite

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“…In 2016 trial report comparing stylet vs non-stylet 22F Foley catheters inserted digitally, when the data for their nulliparas subpopulation was considered, insertion duration were median 1.78 [IQR 1.23-2.46] vs 2.08 [1.33-3.38] minutes, procedure related pain score mean 4.82 95% CI 3.56-6.08 vs 4.52 95% CI 3.51-5.53 and failed insertion rates of 4/28 (14.3%) vs 4/30 (13.3%) [16]. In our digital insertion arm (with unmodified 16F siliconecoated latex Foley catheter) insertion duration was mean (standard deviation) 2.72 ± 1.85 min, procedure related mean pain score 3.6 ± 2.4 and failure rate 2/42 (5 95% CI 0.5-16.7%).…”

Section: Discussionmentioning

confidence: 99%

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial

Chia

Tan

et al. 2020

BMC Pregnancy Childbirth

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Background: Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. Methods: A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. Results: Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. Conclusion: Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. Trial registration: This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.

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“…Procedure‐related pain score was reported using a visual numerical rating scale (VNRS: 0–10; 0 no pain to 10 worst pain imaginable). Failure of insertion is defined as a placement time exceeded 5 min (95% upper limit from Forgie et al 15 ), or abandon by care provider or on the request of participants for any reason.…”

Section: Methodsmentioning

confidence: 99%

Digital insertion of Foley catheter 16F versus 22F versus 28F in unripe cervix labor induction: A randomized trial

Lim

Zakaria

Hong

et al. 2022

J of Obstet and Gynaecol

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Aim To explore digital insertion in dorsal recumbent position of 16F, 22F, or 28F catheter bores on insertion failure, duration, and pain in unripe cervix labor induction. Methods A randomized trial was performed in a University hospital in Malaysia. Term women scheduled for labor induction, Bishop score ≤ 5, singleton, cephalic presentation, intact membrane, and reassuring pre‐induction fetal heart rate tracing were recruited. Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded. Participants were randomized to 16F, 22F, or 28F Foley catheter. Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain (assessed by a Visual Numerical Rating Scale [VNRS] 0–10, higher score more pain). Analysis is done by analysis of variance (ANOVA), Kruskal–Wallis, and chi square test across the three arms and by t test and Mann–Whitney U test for pair wise comparisons. Results One hundred twenty‐seven participants' data were analyzed. The insertion failure 7/43(16%) versus 4/42(10%) versus 5/42(12%), p = 0.64, insertion duration median [IQR] 2.8 [1.8–4.8] versus 2.8 [1.7–3.7] versus 2.8 [1.7–4.3] min, p = 0.68 and insertion pain VNRS mean {SD} 4.2 {2.5} versus 3.4 {2.3} versus 3.6 {2.2}, p = 0.26, insertion to delivery interval 26.0 {9.7} versus 25.6 {9.1} versus 22.8 {7.4} h, p = 0.45, and spontaneous vaginal delivery 20/43 (45%) versus 23/42(55%) versus 25/42(60%), p = 0.48 for 16F versus 22F versus 28F arms, respectively. Pairwise comparisons were not different. Conclusion Foley catheter 16F versus 22F versus 28F resulted in similar digital insertion performance in the dorsal recumbent position for unripe cervix labor induction. Clinical Trial Registration: https://doi.org/10.1186/ISRCTN21224268.

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Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial

Cited by 11 publications

References 14 publications

Mechanical methods for induction of labour

Mechanical methods for induction of labour

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial

Digital insertion of Foley catheter 16F versus 22F versus 28F in unripe cervix labor induction: A randomized trial

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