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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01402310
First received: March 17, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Prolonged Labor
 Other: Ultrasound and digital cervical examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Onset of labor/delivery ≤10days [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cesarean delivery in labor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    1. Time to onset of spontaneous labor
    2. Postterm delivery (≥40 + 11 weeks of pregnancy)
    3. The rate of cesarean delivery


Biospecimen Retention:   Samples Without DNA

cervicovaginal fluid


Estimated Enrollment: 220
Study Start Date: November 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Single tertiary hospital

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402310

Locations
Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01402310     History of Changes
Other Study ID Numbers: BS_CL_40wk
Study First Received: March 17, 2011
Last Updated: May 23, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Onset of labor
Bishop score
Cervical length
Multiple proteins
Cervicovaginal fluid

ClinicalTrials.gov processed this record on June 17, 2013