Cervical Ripening Balloon in Induction of Labour at Term

NCT02620215 | Completed Phase 4

• 1 other identifier: 2015/2730
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion

  Up to 24 hours after induction of labour

Secondary Outcomes (3)

• Efficacy of Cook's Cervical Ripening Balloonas a devide for induction of labour, in comparison to prostin, in achieving vaginal deliveries

  Up to 96 hours after delivery

• Patient satisfaction of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point scale

  From induction of labour to up to 4 days after delivery

• Patients' experience of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point pain assessment scale

  From induction of labour to up to 4 days after delivery

Study Arms (2)

Cervical Ripening Balloon

EXPERIMENTAL

Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80

Device: Cervical Ripening Balloon

Prostin

ACTIVE COMPARATOR

Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally.

Drug: Prostin

Interventions

Cervical Ripening Balloon DEVICE

Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80

Cervical Ripening Balloon

Prostin DRUG

Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally.

Also known as: Prostin E2 vaginal tablets

Prostin

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• University of Malaya: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Related Publications (2)

• 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.

  PMID: 36996264 DERIVED

• 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.

  PMID: 33973051 DERIVED

MeSH Terms

Interventions

KLK15 protein, human

Study Officials

• Shephali Tagore, MRCOG

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2015
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

SG (1)