Obstetric Labor Complications
Conditions
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.
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?
Interventions
DEVICEIntrauterine 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.
DEVICEIntrauterine pressure catheter (IUPC) absent
Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients who develop an intrapartum infection | From enrollment to delivery |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Department of Ob/Gyn
Outcome results
None listed