Transvaginal Ultrasound As Predictors of Successful Induc... | NCT04477226

Studies
Transvaginal Ultrasound As Predictors of Successful Induction of Labour

NCT04477226

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Status

Completed

Last Update Posted

Jul 20, 2020Actual

Enrollment

294Actual

Phase

Not provided

Conditions

Induction of Labour

Interventions

Transvaginal ultrasound scan

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jul 14, 2020

First Submission Date that Met QC Criteria

Jul 14, 2020

First Posted Date

Jul 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2020

Last Update Posted Date

Jul 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

294Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transvaginal ultrasound scan	Diagnostic Test	Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only female pregnant patient

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kah Teik Chew	UKMMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universiti Kebangsaan Malaysia Medical Centre		Kuala Lumpur		56000	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided