Transvaginal Ultrasound As Predictors of Successful Induction of Labour

Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labour
• Intervention / Treatment: Diagnostic test: Transvaginal ultrasound scan

Detailed Description

The aim of this prospective study is 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.

• Study Type: Observational
• Enrollment (Actual): 294

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 56000
    • Universiti Kebangsaan Malaysia Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Kah Teik Chew, UKMMC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FF-2019-368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No