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Two Methods of Diagnosing Preterm Labor

This study is currently recruiting participants.
Verified May 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Conrad Chao, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01431885
First received: August 24, 2011
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Preterm Labor
Preterm Delivery
 Procedure: Diagnosis by cervical length and fibronectin
Procedure: Cervical change
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Delivery prior to 37 weeks' gestation [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 136
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: None applicable

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431885

Contacts
Contact: Conrad R Chao, MD 559-499-6548 cchao@fresno.ucsf.edu

Locations
United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93701
Principal Investigator: Conrad R Chao, MD            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Conrad R Chao, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Conrad Chao, Health Sciences Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01431885     History of Changes
Other Study ID Numbers: 2010010
Study First Received: August 24, 2011
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
fibronectin
cervical length

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013