NCT04477226

Brief Summary

To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 14, 2020

Last Update Submit

July 14, 2020

Conditions

Induction of Labour

Outcome Measures

Primary Outcomes (1)

  • To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction

    measurement of cervical length in cm

    before induction of labour

Interventions

Transvaginal ultrasound scanDIAGNOSTIC_TEST

Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female pregnant patient
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients who are admitted for induction of labour and fulfils the criteria will be recruited from Patient Admission Centre (PAC), antenatal ward, labour room

You may qualify if:

  • Nulliparous or multipara
  • Singleton live pregnancy
  • Gestational age between 37 - 42 weeks
  • Cephalic presentation
  • Intact membranes
  • Reactive cardiotocograph tracing
  • Low risk pregnancy

You may not qualify if:

  • Previous history of uterine surgery
  • Low lying placenta, placenta praevia and vaginal bleeding
  • Multiple pregnancy
  • Preterm Prelabour rupture of membrane/ prelabour rupture of membranes
  • Known allergy towards prostaglandins
  • Intrauterine fetal death
  • Known fetal anomaly
  • Estimated fetal weight \>3.8kg by scan
  • Grandmultiparity (more than 5)
  • BMI \>40kg/m2
  • Diabetes and hypertension on treatment
  • Other medical illness on treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

Location

Study Officials

  • Kah Teik Chew

    UKMMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 20, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)