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This is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. It will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.
Can amniotic fluid be serially aspirated via an Intrauterine pressure catheter (IUPC) and successfully analyzed in labor? Do abnormal amniotic fluid results collected serially predict which laboring patients will develop an intrapartum infection? Can the results predict infection sooner than the current clinical diagnostic criteria as outlined by the 2015 NICHD guidelines? How do the sensitivity, specificity, positive and negative predictive values compare to the 2015 NICHD diagnostic criteria?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrauterine pressure catheter (IUPC) present | Active Comparator | An IUPC is placed through the standard of care. |
|
| Intrauterine pressure catheter (IUPC) absent | Active Comparator | No IUPC is required |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine pressure catheter (IUPC) present | Device | Amniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients who develop an intrapartum infection | From enrollment to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Department of Ob/Gyn | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam Crosland, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science Univerity | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Intrauterine pressure catheter (IUPC) absent | Device | Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed. |
|