Cervical Ripening Balloon in Induction of Labour at Term
Summary
About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain. The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-12-07
- Completion
- 2017-12-07
Publications
- de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Grace Ng YH, Aminuddin AA, Tan TL, Kuppusamy R, Tagore S, Yeo GSH. Multicentre randomised controlled trial comparing the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour. Arch Gynecol Obstet. 2022 Jan;305(1):11-18. doi: 10.1007/s00404-021-06090-y. Epub 2021 May 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dinoprostone | Other / unclassified | 3 mg | Other |