Amniotic Fluid Analysis

Obstetric Labor Complications Clinical Trial

Official title:

Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131684
• Other study ID #: STUDY00024844
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Women's Health Research Unit Department of Ob/Gyn
• Phone: 503-494-3666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

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.
• Intrauterine pressure catheter (IUPC) absent
Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.

Locations

Country	Name	City	State
United States	Oregon Health & Science Univerity	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients who develop an intrapartum infection		From enrollment to delivery