Amniotic Fluid Analysis

Early Phase 1

Not yet recruiting

• Conditions: Obstetric Labor Complications
• Interventions: Device: Intrauterine pressure catheter (IUPC) absent; Device: Intrauterine pressure catheter (IUPC) present

• Registration Number: NCT06131684
• Lead Sponsor: Oregon Health and Science University

Brief 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?

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrauterine pressure catheter (IUPC) absent	Intrauterine pressure catheter (IUPC) absent	No IUPC is required
Intrauterine pressure catheter (IUPC) present	Intrauterine pressure catheter (IUPC) present	An IUPC is placed through the standard of care.

Primary Outcome Measures

Name	Time	Method
The number of patients who develop an intrapartum infection	From enrollment to delivery

Trial Locations

Locations (1)

Oregon Health & Science Univerity; 🇺🇸 Portland, Oregon, United States