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Two Methods of Diagnosing Preterm Labor

Primary Purpose

Preterm Labor, Preterm Delivery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnosis by cervical length and fibronectin
Cervical change
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Labor focused on measuring fibronectin, cervical length

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Community Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PLAT

Cervical Change

Arm Description

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

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

Outcomes

Primary Outcome Measures

Delivery prior to 37 weeks' gestation
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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2011
Last Updated
January 14, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01431885
Brief Title
Two Methods of Diagnosing Preterm Labor
Official Title
Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 13, 2015 (Actual)
Study Completion Date
February 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Preterm Delivery
Keywords
fibronectin, cervical length

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLAT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cervical Change
Arm Type
Placebo Comparator
Arm Description
Diagnosis of preterm labor will be made by cervical change by digital examination
Intervention Type
Procedure
Intervention Name(s)
Diagnosis by cervical length and fibronectin
Other Intervention Name(s)
March of Dimes Preterm Labor Assessment Toolkit Algorithm B
Intervention Description
Diagnosis will be made by MOD Algorithm B
Intervention Type
Procedure
Intervention Name(s)
Cervical change
Other Intervention Name(s)
None applicable
Intervention Description
Diagnosis will be made by digital examination of cervical change
Primary Outcome Measure Information:
Title
Delivery prior to 37 weeks' gestation
Description
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
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad R Chao, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Two Methods of Diagnosing Preterm Labor

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