Clincosm LogoSign in Get a demo

Amniotic Fluid Analysis

Sponsor
Oregon Health and Science University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06131684
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intrauterine pressure catheter (IUPC) present
  • Device: Intrauterine pressure catheter (IUPC) absent
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The number of patients who develop an intrapartum infection [From enrollment to delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health & Science Univerity Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Croslanda, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT06131684
Other Study ID Numbers:
  • STUDY00024844
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obstetric Labor Complications

Study Results

No Results Posted as of Nov 14, 2023