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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLAT | Active Comparator | 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 | Placebo Comparator | Diagnosis of preterm labor will be made by cervical change by digital examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnosis by cervical length and fibronectin | Procedure | Diagnosis will be made by MOD Algorithm B |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conrad R Chao, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Fresno | California | 93701 | United States |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005353 | Fibronectins |
| ID | Term |
|---|---|
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Cervical change | Procedure | Diagnosis will be made by digital examination of cervical change |
|
|
| D012712 |
| Serum Globulins |
| D005916 | Globulins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |