NCT01402310

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 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

November 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

March 17, 2011

Last Update Submit

December 8, 2013

Conditions

Prolonged Labor

Keywords

Onset of laborBishop scoreCervical lengthMultiple proteinsCervicovaginal fluid

Outcome Measures

Primary Outcomes (1)

  • Onset of labor/delivery ≤10days

    Baseline

Secondary Outcomes (1)

  • Cesarean delivery in labor

    Baseline

Study Arms (1)

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

Ultrasound and digital cervical examinationOTHER

Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples

Women attending antenatal clinic

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Single tertiary hospital

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cervicovaginal fluid

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Kyo Hoon Park, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2011

First Posted

July 26, 2011

Study Start

November 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

KR(1)