Cervical Ripening Balloon in Induction of Labour at Term

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Collaborator: University of Malaya
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• Pregnant women aged 21 - 40 years old

• Singleton pregnancy with no major fetal anomaly

• Planned induction of labour at 37+0 weeks to 41+6 weeks gestation

• Vaginal delivery is appropriate

• Patient able to give informed consent to participate in the trial

Exclusion Criteria:

• Spontaneous labour at start of planned induction

• Bishop score <6 and cervical dilatation >=3 cm at start of induction

• Confirmed rupture of membrane

• Abnormal CTG at start of induction

• Caesarean section delivery is indicated

• Scarred uterus such as previous caesarean section

• Malpresentation in labour

• Latex allergy, severe asthma and glaucoma

• Patient withdraw consent to participate in the trial