Two Methods of Diagnosing Preterm Labor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor

Conditions
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Preterm Labor, Preterm Delivery

Intervention / Treatment
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* Procedure: Diagnosis by cervical length and fibronectin
* Procedure: Cervical change


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PLAT<br>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<br>* Diagnosis will be made by MOD Algorithm B<br>* Other names: March of Dimes Preterm Labor Assessment Toolkit Algorithm B;|
| Placebo Comparator: Cervical Change<br>Diagnosis of preterm labor will be made by cervical change by digital examination | Procedure: Cervical change<br>* Diagnosis will be made by digital examination of cervical change<br>* Other names: None applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibronectin, cervical length