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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01402310
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Prolonged Labor Other: Ultrasound and digital cervical examination

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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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

Primary Outcome Measures :
  1. Onset of labor/delivery ≤10days [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA
cervicovaginal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Single tertiary hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01402310

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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
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Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
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Responsible Party: Seoul National University Hospital Identifier: NCT01402310    
Other Study ID Numbers: BS_CL_40wk
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by Seoul National University Hospital:
Onset of labor
Bishop score
Cervical length
Multiple proteins
Cervicovaginal fluid