Amniotic Fluid Analysis
Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2023
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedNovember 14, 2023
November 1, 2023
8 months
November 9, 2023
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The number of patients who develop an intrapartum infection
From enrollment to delivery
Study Arms (2)
Intrauterine pressure catheter (IUPC) present
ACTIVE COMPARATORAn IUPC is placed through the standard of care.
Intrauterine pressure catheter (IUPC) absent
ACTIVE COMPARATORNo IUPC is required
Interventions
Amniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care.
Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Age of participant ≥ 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science Univerity
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Crosland, MD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 14, 2023
Study Start
November 1, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share