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

December 8, 2013 updated by: Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Single tertiary hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kyo Hoon Park, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 8, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BS_CL_40wk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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