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Cervical Ripening Balloon in Induction of Labour at Term

NCT02620215 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2018-08-16

No results posted yet for this study

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

Interventions

DEVICE

Cervical Ripening Balloon

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

DRUG

Prostin

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.

Sponsors & Collaborators

  • University of Malaya

    collaborator OTHER

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Shephali Tagore, MRCOG · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-12-07
Completion
2017-12-07

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620215 on ClinicalTrials.gov