Two Methods of Diagnosing Preterm Labor

Not Applicable

Completed

• Conditions: Preterm Delivery; Preterm Labor
• Interventions: Procedure: Diagnosis by cervical length and fibronectin; Procedure: Cervical change

• Registration Number: NCT01431885
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Primary Completion: 2015-02-13
• Study Completion: 2015-02-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• symptomatic complaints suggestive of preterm labor
• greater than 6 contractions per hour

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLAT	Diagnosis by cervical length and fibronectin	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
Cervical Change	Cervical change	Diagnosis of preterm labor will be made by cervical change by digital examination

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States