Amniotic Fluid Analysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model

Conditions
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Obstetric Labor Complications

Intervention / Treatment
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* Device: Intrauterine pressure catheter (IUPC) present
* Device: Intrauterine pressure catheter (IUPC) absent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Gestational age ≥ 37 weeks Age of participant ≥ 18 years old Exclusion Criteria: Multiple gestation Gestational age < 37 weeks Intrauterine fetal demise Fetal anomalies Pre-gestational Diabetics / Gestational Diabetics Chronic immune suppression with steroids (defined as > 1 month of consistent steroid use) Oligohydramnios Women with documented non-obstetric infections within 2 weeks of admission; including use of any antibiotics within 2 weeks of admission for non-documented/suspected infections Repeat temperature not performed within 45 minutes of index fever (100.4 F) Index fever (100.4 F) is > 1 hour after delivery Expectantly managed premature rupture of membranes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrauterine pressure catheter (IUPC) present<br>An IUPC is placed through the standard of care. | Device: Intrauterine pressure catheter (IUPC) present<br>* Amniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care.<br>|
| Active Comparator: Intrauterine pressure catheter (IUPC) absent<br>No IUPC is required | Device: Intrauterine pressure catheter (IUPC) absent<br>* Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who develop an intrapartum infection |  | From enrollment to delivery |