Obstetric Labor ComplicationsEarly Phase 1NCT06131684
Amniotic Fluid Analysis
A Early Phase 1 study testing Intrauterine pressure catheter (IUPC) present and Intrauterine pressure catheter (IUPC) absent in people with Obstetric Labor Complications, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- Intrauterine pressure catheter (IUPC) present and Intrauterine pressure catheter (IUPC) absent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2023to 30 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Age of participant ≥ 18 years old
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science Univerity
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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?
- Conditions
- Obstetric Labor Complications
- Being tested
- Intrauterine pressure catheter (IUPC) present, Intrauterine pressure catheter (IUPC) absent
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine pressure catheter (IUPC) presentDevice
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) absentDevice
Patients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine pressure catheter (IUPC) present | Active comparator | An IUPC is placed through the standard of care. Receives: Device: Intrauterine pressure catheter (IUPC) present |
| Intrauterine pressure catheter (IUPC) absent | Active comparator | No IUPC is required Receives: Device: Intrauterine pressure catheter (IUPC) absent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who develop an intrapartum infection
Measured: From enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study startNov 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Croslanda, Oregon Health and Science University
- Investigators
- Adam Crosland, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131684
- Sponsor's protocol ID
- STUDY00024844
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model
- ClinicalTrials.gov ID
- NCT06131684
- Acronym / sponsor ID
- STUDY00024844
- Conditions
- Obstetric Labor Complications
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine pressure catheter (IUPC) present | Active comparator | Device: Intrauterine pressure catheter (IUPC) presentAn IUPC is placed through the standard of care. |
| Intrauterine pressure catheter (IUPC) absent | Active comparator | Device: Intrauterine pressure catheter (IUPC) absentNo IUPC is required |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Age of participant ≥ 18 years old
Key exclusion criteria (11 listed)
- Multiple gestation
- Gestational age < 37 weeks
- Intrauterine fetal demise
- Fetal anomalies
- Pre-gestational Diabetics / Gestational Diabetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine pressure catheter (IUPC) presentAmniotic fluid will be analyzed every 3 hours for the duration of labor for patients who require an IUPC through the standard of care. | Device | Intrauterine pressure catheter (IUPC) present |
| Intrauterine pressure catheter (IUPC) absentPatients that do not require an IUPC through the standard of care will not have amniotic fluid analyzed. | Device | Intrauterine pressure catheter (IUPC) absent |
Primary outcome
The number of patients who develop an intrapartum infection
Time frame: From enrollment to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Crosland, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intrauterine pressure catheter (IUPC) present and Intrauterine pressure catheter (IUPC) absent in people with Obstetric Labor Complications, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who develop an intrapartum infection (time frame: From enrollment to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.