Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)

M. D.T. de Vaan; D. Blel; K. W.M. Bloemenkamp; M. Jozwiak; M. L.G. ten Eikelder; J. W. de Leeuw; M. A. Oudijk; J. J.H. Bakker; R. J.P. Rijnders; D. N. Papatsonis; M. Woiski; B. W. Mol; R. de Heus

doi:10.1002/uog.23117

Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)

M. D.T. de Vaan^*, D. Blel, K. W.M. Bloemenkamp, M. Jozwiak, M. L.G. ten Eikelder, J. W. de Leeuw, M. A. Oudijk, J. J.H. Bakker, R. J.P. Rijnders, D. N. Papatsonis, M. Woiski, B. W. Mol, R. de Heus

^*Corresponding author for this work

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

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Abstract

OBJECTIVE: The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins.

METHODS: This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study.

RESULTS: 14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51).

CONCLUSIONS: In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.

Original language	English
Pages (from-to)	292-297
Number of pages	6
Journal	Ultrasound in Obstetrics and Gynecology
Volume	57
Issue number	2
Early online date	1 Feb 2021
DOIs	https://doi.org/10.1002/uog.23117
Publication status	Published - Feb 2021

Bibliographical note

Acknowledgements
We thank all the women who participated in the PROBAAT trials and all participating
institutions and their staff for their contribution to this follow-up study.

Funding
The original PROBAAT-2 trial was funded by FondsNutsOhra. For the PROBAAT-1 trial and this follow-up study, no funding was received. MV received a doctoral grant for teachers by the Netherlands Organisation for Scientific Research (023.011.051). BM is supported by a NHMRC Practitioner Fellowship (GNT1082548). Funding sources had no role in design, execution, analyses, interpretation, or decision to submit results.

Keywords

balloon
cervical ripening
Foley catheter
induction of labor
preterm birth

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© 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/
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de Vaan, M. D. T., Blel, D., Bloemenkamp, K. W. M., Jozwiak, M., ten Eikelder, M. L. G., de Leeuw, J. W., Oudijk, M. A., Bakker, J. J. H., Rijnders, R. J. P., Papatsonis, D. N., Woiski, M., Mol, B. W., & de Heus, R. (2021). Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2). Ultrasound in Obstetrics and Gynecology, 57(2), 292-297. https://doi.org/10.1002/uog.23117

de Vaan, MDT, Blel, D, Bloemenkamp, KWM, Jozwiak, M, ten Eikelder, MLG, de Leeuw, JW, Oudijk, MA, Bakker, JJH, Rijnders, RJP, Papatsonis, DN, Woiski, M, Mol, BW & de Heus, R 2021, 'Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)', Ultrasound in Obstetrics and Gynecology, vol. 57, no. 2, pp. 292-297. https://doi.org/10.1002/uog.23117

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abstract = "OBJECTIVE: The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins.METHODS: This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study.RESULTS: 14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51).CONCLUSIONS: In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.",

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author = "{de Vaan}, {M. D.T.} and D. Blel and Bloemenkamp, {K. W.M.} and M. Jozwiak and {ten Eikelder}, {M. L.G.} and {de Leeuw}, {J. W.} and Oudijk, {M. A.} and Bakker, {J. J.H.} and Rijnders, {R. J.P.} and Papatsonis, {D. N.} and M. Woiski and Mol, {B. W.} and {de Heus}, R.",

note = "Acknowledgements We thank all the women who participated in the PROBAAT trials and all participating institutions and their staff for their contribution to this follow-up study. Funding The original PROBAAT-2 trial was funded by FondsNutsOhra. For the PROBAAT-1 trial and this follow-up study, no funding was received. MV received a doctoral grant for teachers by the Netherlands Organisation for Scientific Research (023.011.051). BM is supported by a NHMRC Practitioner Fellowship (GNT1082548). Funding sources had no role in design, execution, analyses, interpretation, or decision to submit results.",

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AU - de Vaan, M. D.T.

AU - Blel, D.

AU - Bloemenkamp, K. W.M.

AU - Jozwiak, M.

AU - ten Eikelder, M. L.G.

AU - de Leeuw, J. W.

AU - Oudijk, M. A.

AU - Bakker, J. J.H.

AU - Rijnders, R. J.P.

AU - Papatsonis, D. N.

AU - Woiski, M.

AU - Mol, B. W.

AU - de Heus, R.

N1 - Acknowledgements We thank all the women who participated in the PROBAAT trials and all participating institutions and their staff for their contribution to this follow-up study. Funding The original PROBAAT-2 trial was funded by FondsNutsOhra. For the PROBAAT-1 trial and this follow-up study, no funding was received. MV received a doctoral grant for teachers by the Netherlands Organisation for Scientific Research (023.011.051). BM is supported by a NHMRC Practitioner Fellowship (GNT1082548). Funding sources had no role in design, execution, analyses, interpretation, or decision to submit results.

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N2 - OBJECTIVE: The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins.METHODS: This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study.RESULTS: 14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51).CONCLUSIONS: In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.

AB - OBJECTIVE: The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins.METHODS: This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study.RESULTS: 14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51).CONCLUSIONS: In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.

KW - balloon

KW - cervical ripening

KW - Foley catheter

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KW - preterm birth

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Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)

Abstract

Bibliographical note

Keywords

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