Bishop Score, Cervical Length and Multiple Proteins in Ce... | NCT01402310

Studies
Bishop Score, Cervical Length and Multiple Proteins in Cervicovaginal Fluid at 40 Weeks to Predict Onset of Labor

NCT01402310

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 10, 2013Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Prolonged Labor

Interventions

Ultrasound and digital cervical examination

Countries

South Korea

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

Dec 2013

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

Nov 2008

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Mar 17, 2011

First Submission Date that Met QC Criteria

Jul 25, 2011

First Posted Date

Jul 26, 2011Estimated

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

Dec 8, 2013

Last Update Posted Date

Dec 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to compare Bishop score, sonographic cervical length and multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to spontaneous labor and mode of delivery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women attending antenatal clinic		Women attending antenatal clinic were consecutively enrolled at between 39+6 and 40+1 weeks of gestation.	Other: Ultrasound and digital cervical examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound and digital cervical examination	Other	Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples	Women attending antenatal clinic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset of labor/delivery ≤10days		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Cesarean delivery in labor	Time to onset of spontaneous labor Postterm delivery (≥40 + 11 weeks of pregnancy) The rate of cesarean delivery	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between 39+6 and 40+1 weeks of gestation
singleton pregnancy
viable fetus with vertex presentation
intact amniotic membranes
no pregnancy complications
absence of labor
no history of previous uterine surgery
planned vaginal delivery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Single tertiary hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyo Hoon Park, MD, PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

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Browse Branches

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