Abstract
The aim of this thesis was to further investigate obstetrical and perinatal safety outcomes of induction of labour with a balloon catheter in comparison to other induction agents in a general pregnant population as well as in specific subgroups of people.
Chapter 1 introduces a global overview of what is known on different methods for induction of labour.
In Chapter 2, we describe a systematic review and meta-analyses on the safety and of mechanical labour induction in comparison to different pharmacological methods. We included a total of 112 randomised controlled trials, with 104 studies contributing data involving 22,055 individuals. We concluded that a balloon is as effective as vaginal PGE2, but a balloon seems to have a more favourable safety profile. And with the evidence at hand, more research on this comparison does not seem warranted. And although a balloon catheter may be slightly less effective compared to oral misoprostol, it remains unclear if there is a difference in safety outcomes for the neonate as the results were still too imprecise to make a valid judgement.
Chapter 3 describes the result of a secondary analysis of a combined database of two previously published randomised controlled trials (the PROBAAT-1 and PROBAAT-2 trial) about the safety aspects of a 30cc-Foley balloon catheter, vaginal PGE2 and oral misoprostol in pregnancies with small-for-gestational-age neonates (n=425). Our primary outcome was a composed adverse neonatal outcome of Apgar score <7 after 5 minutes and/or a pH in the umbilical artery <7.05 and/or NICU admission. We concluded that in pregnancies with a small-for-gestational-age neonate, a Foley catheter is probably a safer induction method compared to oral misoprostol. For PGE2, the numbers were too low to make a valid judgement compared to a Foley balloon catheter within this specific subgroup.
In Chapter 4 we describe the results of another secondary analysis we performed on the PROBAAT-1 and PROBAAT-2 trials, on the effect of labour induction with a Foley balloon catheter, oral misoprostol or vaginal PGE2 in patients with obesity (BMI ≥30). Our primary outcomes were caesarean section and post-partum-haemorrhage (PPH) (n=517). We concluded that a Foley balloon catheter might be equally safe and effective in obese persons although and there might be an increased risk of a failed placement of the Foley balloon catheter in this specific subgroup.
In Chapter 5 we explored the possible risk of preterm birth in a subsequent pregnancy after term induction with a Foley balloon catheter. For this purpose, we conducted a follow-up study of the PROBAAT-1 and PROBAAT-2 studies, in which patients were randomised to either a 30cc Foley catheter or prostaglandins (Prostaglandin E2; PROBAAT 1 or oral misoprostol; PROBAAT 2).
Results of this studies study show that induction of labour with Foley catheter was not associated with an increased risk of preterm birth in a subsequent pregnancy.
In Chapter 6 we discuss our findings in broader perspective in and in relation to what is already known in existing literature. From within this context, we made recommendations for practice and future research
Chapter 1 introduces a global overview of what is known on different methods for induction of labour.
In Chapter 2, we describe a systematic review and meta-analyses on the safety and of mechanical labour induction in comparison to different pharmacological methods. We included a total of 112 randomised controlled trials, with 104 studies contributing data involving 22,055 individuals. We concluded that a balloon is as effective as vaginal PGE2, but a balloon seems to have a more favourable safety profile. And with the evidence at hand, more research on this comparison does not seem warranted. And although a balloon catheter may be slightly less effective compared to oral misoprostol, it remains unclear if there is a difference in safety outcomes for the neonate as the results were still too imprecise to make a valid judgement.
Chapter 3 describes the result of a secondary analysis of a combined database of two previously published randomised controlled trials (the PROBAAT-1 and PROBAAT-2 trial) about the safety aspects of a 30cc-Foley balloon catheter, vaginal PGE2 and oral misoprostol in pregnancies with small-for-gestational-age neonates (n=425). Our primary outcome was a composed adverse neonatal outcome of Apgar score <7 after 5 minutes and/or a pH in the umbilical artery <7.05 and/or NICU admission. We concluded that in pregnancies with a small-for-gestational-age neonate, a Foley catheter is probably a safer induction method compared to oral misoprostol. For PGE2, the numbers were too low to make a valid judgement compared to a Foley balloon catheter within this specific subgroup.
In Chapter 4 we describe the results of another secondary analysis we performed on the PROBAAT-1 and PROBAAT-2 trials, on the effect of labour induction with a Foley balloon catheter, oral misoprostol or vaginal PGE2 in patients with obesity (BMI ≥30). Our primary outcomes were caesarean section and post-partum-haemorrhage (PPH) (n=517). We concluded that a Foley balloon catheter might be equally safe and effective in obese persons although and there might be an increased risk of a failed placement of the Foley balloon catheter in this specific subgroup.
In Chapter 5 we explored the possible risk of preterm birth in a subsequent pregnancy after term induction with a Foley balloon catheter. For this purpose, we conducted a follow-up study of the PROBAAT-1 and PROBAAT-2 studies, in which patients were randomised to either a 30cc Foley catheter or prostaglandins (Prostaglandin E2; PROBAAT 1 or oral misoprostol; PROBAAT 2).
Results of this studies study show that induction of labour with Foley catheter was not associated with an increased risk of preterm birth in a subsequent pregnancy.
In Chapter 6 we discuss our findings in broader perspective in and in relation to what is already known in existing literature. From within this context, we made recommendations for practice and future research
Original language | English |
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Awarding Institution |
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Supervisors/Advisors |
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Award date | 21 Dec 2023 |
Publisher | |
Print ISBNs | 978-94-6469-697-4 |
DOIs | |
Publication status | Published - 21 Dec 2023 |
Keywords
- induction of labour
- IOL
- balloon catheter
- Foley balloon
- misoprostol
- PGE1
- prostaglandin E2
- PGE2
- FGR
- obesity