Amniotic Fluid Analysis

NCT ID: NCT06131684

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-06-30

Brief Summary

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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

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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?

Conditions

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Obstetric Labor Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intrauterine pressure catheter (IUPC) present

An IUPC is placed through the standard of care.

Group Type ACTIVE_COMPARATOR

Intrauterine pressure catheter (IUPC) present

Intervention Type DEVICE

Amniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care.

Intrauterine pressure catheter (IUPC) absent

No IUPC is required

Group Type ACTIVE_COMPARATOR

Intrauterine pressure catheter (IUPC) absent

Intervention Type DEVICE

Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.

Interventions

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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.

Intervention Type DEVICE

Intrauterine pressure catheter (IUPC) absent

Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Croslanda

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Crosland, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science Univerity

Portland, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Women's Health Research Unit Department of Ob/Gyn

Role: CONTACT

503-494-3666

Other Identifiers

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STUDY00024844

Identifier Type: -

Identifier Source: org_study_id

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