NCT06131684

Amniotic Fluid Analysis

Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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?

Conditions

• Obstetric Labor Complications

Interventions

Type	Name	Description
DEVICE	Intrauterine pressure catheter (IUPC) present	Amniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care.
DEVICE	Intrauterine pressure catheter (IUPC) absent	Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-11-14
• Last updated: 2023-11-14

Locations

1 site across 1 country: United States