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NCT01402310 Clinical Trial

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

Prolonged Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01402310
Other study ID # BS_CL_40wk
Secondary ID
Status Completed
Phase N/A
First received March 17, 2011
Last updated December 8, 2013
Start date November 2008
Est. completion date September 2012

Study information
Verified date December 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review BoardKorea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Ultrasound and digital cervical examination
Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples

Locations
Country Name City State
Korea, Republic of Department of Obstetrics and Gynecology Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Onset of labor/delivery =10days Baseline No
Secondary Cesarean delivery in labor Time to onset of spontaneous labor
Postterm delivery (=40 + 11 weeks of pregnancy)
The rate of cesarean delivery		 Baseline No
See also
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Completed NCT05206409 - Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.
Recruiting NCT01854073 - Hyoscine Butyl Bromide for Management of Prolonged Labor Phase 3
Recruiting NCT06268431 - Oxytocin Rest to Reduce Cesarean Delivery N/A
Completed NCT03509103 - Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh N/A
Completed NCT02318121 - Amniotomy and Oxytocin for Augmentation of Labour Phase 2