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Two Methods of Diagnosing Preterm Labor

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01431885
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
42.4
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Diagnosis by cervical length and fibronectin
  • Procedure: Cervical change
 N/A

Detailed Description

Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Feb 13, 2015
Actual Study Completion Date :
Feb 13, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PLAT

Diagnosis of preterm labor will be made by the March of Dimes Preterm Labor Assessment Toolkit Algorithm B, incorporating transvaginal ultrasound measurement of cervical length, and vaginal fetal fibronectin

Procedure: Diagnosis by cervical length and fibronectin
Diagnosis will be made by MOD Algorithm B
Other Names:
  • March of Dimes Preterm Labor Assessment Toolkit Algorithm B

    		•
    Placebo Comparator: Cervical Change

    Diagnosis of preterm labor will be made by cervical change by digital examination

    Procedure: Cervical change
    Diagnosis will be made by digital examination of cervical change
    Other Names:
  • None applicable

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Delivery prior to 37 weeks' gestation [No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)]

      Delivery of the baby prior to 37 weeks' gestation by any means and for any reason including spontaneous or indicated delivery for maternal or fetal complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • symptomatic complaints suggestive of preterm labor

    • greater than 6 contractions per hour

    Exclusion Criteria:

    • multiple gestation

    • rupture of amniotic membranes

    • chorioamnionitis

    • congenital malformations

    • persistent vaginal bleeding

    • abruptio placentae

    • placenta previa

    • previously diagnosed short cervix < 2.5 cm

    • cervical dilation > 3 cm

    • cervical cerclage

    • exposure to tocolytic drugs

    • allergy or contraindication to nifedipine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Community Regional Medical Center Fresno California United States 93701

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Conrad R Chao, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT01431885
    Other Study ID Numbers:
    • 2010010
    First Posted:
    Sep 12, 2011
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by University of California, San Francisco
    fibronectin
    cervical length
    Additional relevant MeSH terms:
    Premature Birth
    Obstetric Labor, Premature

    Study Results

    No Results Posted as of Jan 18, 2020