A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP)

Amorosa, Jennifer; Stone, Joanne; Booker, Whitney A.; Newland, Meredith; Bianco, Angela

doi:10.1016/j.ajog.2017.04.038

Cited by 40 publications

(38 citation statements)

References 12 publications

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“…The study of Blumenthal 1990 and Sanchez‐Ramos 1992 took place between 1980 and 1989; the studies of Allouche 1993, Guinn 2000, Hemlin 1998, Hibbard 1998, Khamaiseh 2012, Lyndrup 1994, Orhue 1995, Perry 1998, Roudsari 2011, Roztocil 1998, Sciscione 1999, St Onge 1995, Sullivan 1996 and Turnquest 1997 between 1990 and 1999; the studies of Tabowei 2003, Culver 2004 and Mullin 2002 between 1998 and 2001; the studies of Al‐Taani 2004, Cromi 2011, Deshmukh 2011, Dionne 2011, Filho 2002, Joshi 2016, Jozwiak 2012, Jozwiak 2013, Krammer 1995a, Lokkegaard 2015, Matonhodze 2003, Mazhar 2003, Moini 2003, Niromanesh 2003, Oliveira 2010, Pennell 2009, Prager 2008, Roudsari 2011, Rudra 2012, Saleem 2006, Sharami 2005 and Tita 2006 between 2000 and 2009; the studies of Jozwiak 2014 and Salim 2011 between 2008 and 2011; and the studies of Aduloju 2016, Ahmed 2016, Al‐Ibraheemi 2018, Amorosa 2017, Barda 2018, Browne 2011, Carbone 2013, Chavakula 2015, Cromi 2012, Edwards 2014c, El Khouly 2017, Garba 2016, Goonewardene 2014, Haugland 2012, Henry 2013,…”

Section: Resultsmentioning

confidence: 99%

“…Thirteen studies included women with a specific indication for labour induction or specific patient groups, i.e. women with a hypertensive disease (Mundle 2017), women with a body mass index (BMI) greater than 30 (Pineda Rivas 2016), post‐date pregnancies (Gelisen 2005; Goonewardene 2014; Gunawardena 2012; Kandil 2012; Somirathne 2017), oligohydramnios (Shechter‐Maor 2015; Wang 2014) or pre labour rupture of membranes (PROM; Amorosa 2017; Kruit 2016; Mackeen 2018; Tita 2006). Most authors specified that only women with intact membranes were included, except for Prager 2008, in which this was not an exclusion criteria.…”

Section: Resultsmentioning

confidence: 99%

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Mechanical methods for induction of labour

Vaan

Eikelder

Jozwiak

et al. 2019

Cochrane Database of Systematic Reviews

101

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: Resultsmentioning

confidence: 99%

Mechanical methods for induction of labour

Vaan

Eikelder

Jozwiak

et al. 2019

Cochrane Database of Systematic Reviews

101

117

View full text Add to dashboard Cite

show abstract

“…While no increase in intrapartum fever or nursery admission was demonstrated, the numbers are small and infection risk remains a concern. A few researchers have consciously inserted Foley catheters in situations of known ruptured membranes in one study, a non‐significant doubling of chorioamnionitis incidence was seen in the Foley cohort …”

Section: Commentmentioning

confidence: 99%

Foley catheter silicone versus latex for term outpatient induction of labour: A randomised trial

McGee

Gidaszewski

Khajehei

et al. 2018

Aust NZ J Obst Gynaeco

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“…While prelabour rupture of membranes (PROM) at term is a relative contraindication to mechanical induction, this condition accounts for ~30% of inductions at our institution. Retrospective studies and randomised trials show no differences in the incidence of chorioamnionitis with transcervical balloons in the presence of ruptured membranes compared with oxytocin or vaginal misoprostol 81–83. Thus we will recruit women who meet eligibility criteria even if they are diagnosed with PROM, as detailed in table 2.…”

Section: Discussion Ethics and Disseminationmentioning

confidence: 99%

MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

et al. 2019

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IntroductionLabour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).Methods and analysisThis single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12 hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12 hours’ observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ≥6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24 hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population.Ethics and disseminationEthical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24 hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses.Trial registration number NCT03471858; Pre-results.

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A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP)

Cited by 40 publications

References 12 publications

Mechanical methods for induction of labour

Mechanical methods for induction of labour

Foley catheter silicone versus latex for term outpatient induction of labour: A randomised trial

MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

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A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP)

Cited by 40 publications

References 12 publications

Mechanical methods for induction of labour

Mechanical methods for induction of labour

Foley catheter silicone versus latex for term outpatient induction of labour: A randomised trial

MEchanical DIlatation of the Cervix­­ in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

Contact Info

Product

Resources

About

MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery