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

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

doi:10.1016/S0140-6736(16)00084-2

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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone.

METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466.

FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure.

INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness.

FUNDING: FondsNutsOhra.

Original language	English
Pages (from-to)	1619–1628
Journal	The Lancet
Volume	387
Issue number	10028
DOIs	https://doi.org/10.1016/S0140-6736(16)00084-2
Publication status	Published - Apr 2016

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ten Eikelder, M. L. G., Oude Rengerink, K., Jozwiak, M., de Leeuw, J. W., de Graaf, I. M., van Pampus, M. G., Holswilder, M., Oudijk, M. A., van Baaren, G. J., Pernet, P. J. M., Bax, C., van Unnik, G. A., Martens, G., Porath, M., van Vliet, H., Rijnders, R. J. P., Feitsma, A. H., Roumen, F. J. M. E., van Loon, A. J., ... Bloemenkamp, K. W. M. (2016). Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): A multicentre randomised controlled non-inferiority trial. The Lancet, 387(10028), 1619–1628. https://doi.org/10.1016/S0140-6736(16)00084-2

@article{4756a751f10d4e7db153be5d33d52618,

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

abstract = "BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone.METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466.FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure.INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness.FUNDING: FondsNutsOhra.",

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

year = "2016",

month = apr,

doi = "10.1016/S0140-6736(16)00084-2",

language = "English",

volume = "387",

pages = "1619–1628",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier",

number = "10028",

}

ten Eikelder, MLG, Oude Rengerink, K, Jozwiak, M, de Leeuw, JW, de Graaf, IM, van Pampus, MG, Holswilder, M, Oudijk, MA, van Baaren, GJ, Pernet, PJM, Bax, C, van Unnik, GA, Martens, G, Porath, M, van Vliet, H, Rijnders, RJP, Feitsma, AH, Roumen, FJME, van Loon, AJ, Versendaal, H, Weinans, MJN, Woiski, M, van Beek, E, Hermsen, B, Mol, BW & Bloemenkamp, KWM 2016, 'Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): A multicentre randomised controlled non-inferiority trial', The Lancet, vol. 387, no. 10028, pp. 1619–1628. https://doi.org/10.1016/S0140-6736(16)00084-2

TY - JOUR

T1 - Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II)

T2 - A multicentre randomised controlled non-inferiority trial

AU - ten Eikelder, Mieke L G

AU - Oude Rengerink, Katrien

AU - Jozwiak, Marta

AU - de Leeuw, Jan W.

AU - de Graaf, Irene M.

AU - van Pampus, Mariëlle G.

AU - Holswilder, Marloes

AU - Oudijk, Martijn A.

AU - van Baaren, Gert Jan

AU - Pernet, Paula J M

AU - Bax, Caroline

AU - van Unnik, Gijs A.

AU - Martens, Gratia

AU - Porath, Martina

AU - van Vliet, Huib

AU - Rijnders, Robbert J P

AU - Feitsma, A. Hanneke

AU - Roumen, Frans J M E

AU - van Loon, Aren J.

AU - Versendaal, Hans

AU - Weinans, Martin J N

AU - Woiski, Mallory

AU - van Beek, Erik

AU - Hermsen, Brenda

AU - Mol, Ben Willem

AU - Bloemenkamp, Kitty W M

PY - 2016/4

Y1 - 2016/4

N2 - BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone.METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466.FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure.INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness.FUNDING: FondsNutsOhra.

AB - BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone.METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466.FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure.INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness.FUNDING: FondsNutsOhra.

UR - http://www.scopus.com/inward/record.url?scp=84956648484&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(16)00084-2

DO - 10.1016/S0140-6736(16)00084-2

M3 - Article

C2 - 26850983

SN - 0140-6736

VL - 387

SP - 1619

EP - 1628

JO - The Lancet

JF - The Lancet

IS - 10028

ER -

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

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