Amniotic Fluid Analysis

November 9, 2023 updated by: Croslanda, Oregon Health and Science University

Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Women's Health Research Unit Department of OB/Gyn
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science Univerity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrauterine pressure catheter (IUPC) present
An IUPC is placed through the standard of care.
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.
Active Comparator: Intrauterine pressure catheter (IUPC) absent
No IUPC is required
Device: Intrauterine pressure catheter (IUPC) absent
Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Adam Crosland, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00024844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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