Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial

Eikelder, Mieke L.G. ten; Rengerink, Katrien Oude; Jozwiak, Marta; Leeuw, J.W. de; Graaf, Irene M. de; Pampus, Maria G. van; Holswilder, Marloes; Oudijk, Martijn A.; Baaren, Gert Jan Van; Pernet, Paula; Bax, Caroline J.; Unnik, Gijs A. van; Martens, Gratia; Porath, Martina; Vliet, Huib van; Rijnders, Robbert J.P.; Feitsma, A. Hanneke; Roumen, Frans J.M.E.; Loon, A.J. van; Versendaal, Hans; Weinans, Martin J. N.; Woiski, Mallory; Beek, Erik van; Hermsen, Brenda; Mol, Ben Willem J.; Bloemenkamp, Kitty W. M.

doi:10.1016/s0140-6736(16)00084-2

Cited by 103 publications

(137 citation statements)

References 19 publications

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“…5 Also, women who had their labor induced were less satisfied with the care received compared with women who had spontaneous onset of labor. 8 In women with an unripe cervix requiring induction of labor, both oral misoprostol and the Foley catheter are safer than vaginal prostaglandins. [6][7][8][9] Our recent PRO-BAAT-II trial compared induction of labor with 50-µg oral misoprostol to 30-mL transcervical Foley catheter in women with an unfavorable cervix at term.…”

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confidence: 99%

“…8 In women with an unripe cervix requiring induction of labor, both oral misoprostol and the Foley catheter are safer than vaginal prostaglandins. [6][7][8][9] Our recent PRO-BAAT-II trial compared induction of labor with 50-µg oral misoprostol to 30-mL transcervical Foley catheter in women with an unfavorable cervix at term. The study showed that induction with oral misoprostol was comparable to Foley catheter in terms of safety and effectiveness.…”

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confidence: 99%

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Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

Eikelder

Meent²,

Mast

et al. 2016

Amer J Perinatol

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Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy.

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Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

Eikelder

Meent²,

Mast

et al. 2016

Amer J Perinatol

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“…The insertion of an intra-cervical Foley catheter is a frequently used procedure for pre induction cervical ripening and IOL [6][7][8][9][10][11]. Although this procedure may be associated with accidental rupture of membranes and infections, these risks do not appear to be significantly different from the risks of vaginal prostaglandins [8,10].…”

Section: Introductionmentioning

confidence: 99%

“…In most obstetric units in Sri Lanka the catheter is often removed after 24 hours, and an intravenous oxytocin infusion commenced, following amniotomy. However keeping the intra cervical Foley catheter up to three to four days has been shown to be safe and effective for IOL [7,11]. Vaginal prostaglandins are expensive and well known to cause uterine hyperstimulation which can lead to fetal compromise and even uterine rupture.…”

Section: Introductionmentioning

confidence: 99%

Three doses of oral misoprostol versus an intra-cervical Foley catheter for 24 hours for pre-induction cervical ripening in post- dated pregnancies: a randomized controlled trial

Somirathne¹,

Goonewardene

Dasanayake

2017

Ceylon Med. J.

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Objectives To compare three doses of oral misoprostol 50µg four hourly versus an intra-cervical Foley catheter for 24 hours, for pre-induction cervical ripening.Methods Primary investigator blinded, randomized controlled trial conducted in 180 consecutive women with singleton uncomplicated pregnancies with Modified Bishop Score (MBS) 5 at 40 weeks + 6 days gestation, allocated by stratified (primigravida / multigravida) block randomization to receive three doses of oral misoprostol 50µg four hourly or an intra-cervical Foley catheter for 24 hours. MBS reassessed at 41 weeks gestation. If MBS 7, induction of labour (IOL) with amniotomy and intravenous oxytocin infusion. If MBS<7, cross over therapy with intracervical Foley catheter for misoprostol group, vaginal prostaglandin E 2 for Foley group.Results At commencement, no significant differences in age, parity, body mass index and MBS between the two groups. Greater proportions established labour in both primigravidae (30% vs. 9%; RR=4.4, 95% CI 1.3-14.6; p=0.01) and multigravidae (44%.vs.16%; RR=4.3; 95% CI 1.6-11.8; p=0.003) before 41 weeks of gestation in misoprostol group compared to the Foley group. Among the multigravidae, the mean increase of MBS was greater in the misoprostol group (3.1; 95% CI 2.4-4) compared to the Foley group (2.4; 95% CI 1.9-2.7, p=0.04). One primigravida and two multigravidae developed hyper stimulation after misoprostol therapy. No significant differences in the other maternal and perinatal outcomes.Conclusions Compared to an intra-cervical Foley catheter for 24 hours, three doses of oral misoprostol 50µg four hourly was more effective for cervical ripening and even resulted in IOL.

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“…And whereas in previous studies researchers have been forced to either use cut 200‐ μ g tablets or solution, high‐quality 25‐ μ g tablets are now available. Findings from a non‐inferiority randomised controlled trial (RCT) of oral misoprostol 50mcg versus Foley catheter for induction of labour showed equivalent safety and effectiveness,9 whereas misoprostol tablets (25 μ g) has recently been found to be more an effective than Foley catheter when given orally in a large Medical Research Council (MRC) labour induction study 10…”

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Simplifying oral misoprostol protocols for the induction of labour

Weeks

Navaratnam

Alfirević

2017

BJOG

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Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial

Cited by 103 publications

References 19 publications

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

Three doses of oral misoprostol versus an intra-cervical Foley catheter for 24 hours for pre-induction cervical ripening in post- dated pregnancies: a randomized controlled trial

Simplifying oral misoprostol protocols for the induction of labour

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