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Two Methods of Diagnosing Preterm Labor

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ClinicalTrials.gov Identifier: NCT01431885
Recruitment Status : Unknown
Verified April 2014 by Conrad Chao, University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : September 12, 2011
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Conrad Chao, University of California, San Francisco

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 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 : August 2011
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

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 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




Primary Outcome Measures :
  1. 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) ]
    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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

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

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