Status:
UNKNOWN
Amniotic Fluid Analysis
Lead Sponsor:
Oregon Health and Science University
Conditions:
Obstetric Labor Complications
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
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 patien...
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 p...
Eligibility Criteria
Inclusion
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Age of participant ≥ 18 years old
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06131684
Start Date
November 1 2023
End Date
June 30 2024
Last Update
November 14 2023
Active Locations (1)
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1
Oregon Health & Science Univerity
Portland, Oregon, United States, 97239