Labor (Obstetrics)--ComplicationsBUMPNCT04251702
Biomarkers of Uterine Muscle Physiology
An observational study of Labor (Obstetrics)--Complications and Labor; Dyscoordinate, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This observational study characterizes the relationship between amniotic fluid lactate and uterine electromyography during labor in healthy individuals at term planning a vaginal birth. Additional comparison measures and outcomes measures will be collected and analyzed as exploratory measures. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor (Obstetrics)--Complications, Labor; Dyscoordinate
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 1 Dec 2025
- Phase
- Observational
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 41 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.
Who may be able to join
- Maternal age: 18-41 years at the due date
- Term gestation: 37-41 weeks estimated gestational age (EGA)
- Single fetus in a vertex presentation: Pregnancy with only one fetus that is in a head down position with the occiput leading into the pelvis upon admission to the hospital.
Who cannot join
- Pre-existing or gestational diabetes requiring medical management: The diagnosis of diabetes of any kind requiring management with medications including but not limited to insulin, glyburide, and metformin as indicated in the health record.
- Pre-existing or gestational hypertension or pre-eclampsia requiring medical management: The diagnosis of hypertension of any kind requiring management with medications including but not limited to long-term hypertension management such as methyldopa and short-term or emergency hypertension management such as labetalol or magnesium sulfate as indicated in the health record.
- Suspected fetal anomaly or intrauterine growth restriction: Any diagnosed fetal anomalies or intrauterine growth restriction as indicated in the health record.
- Use of amnioinfusion prior to sample collection: Amnioinfusion, the infusion of fluids into the uterus using an intrauterine catheter may affect AFL concentrations. Any amnioinfusion prior to sample collection will exclude participants from continued participation.
- Fetal distress prior to or during sample collection: Category 3 fetal heart tracing as defined by the National Institute of Child Health and Development22, absent fetal heart rate variability with recurrent late deceleration, recurrent variable decelerations, bradycardia, or sinusoidal rhythm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management
This observational study characterizes the relationship between amniotic fluid lactate and uterine electromyography during labor in healthy individuals at term planning a vaginal birth. Additional comparison measures and outcomes measures will be collected and analyzed as exploratory measures.
Read the detailed description
Elevated amniotic fluid lactate (AFL) and uterine electromyography (EMG) mathematically transformed to calculated the power density spectrum median frequency have been found separately to be associated with labor dystocia and cesarean birth. Similarly, recent research indicates that the cytokine IL-6 may play a critical role in labor onset and potentially labor progression. All three are hypothesized to reflect that uterine fatigue plays a role in the pathophysiology of labor dystocia for some women.
This study aims to characterize the relationship between these three measures to better understand the role of uterine fatigue in labor dystocia and triangulate biomarkers of fatigue that may lead to a better understanding of labor dystocia phenotypes.
In addition to the primary measures, comparison measures will be collected. For AFL comparison, venous whole blood lactate and capillary lactate will be collected and measured using both a point-of-care lactate meter (Stat Strip Lactate Meter, Nova Biomedical) and a table-top blood gas analyzer (Nova Prime). For EMG comparison, routine contraction monitoring data will be collected and compared to the EMG signal. IL-6 will be measured both in blood and amniotic fluid using a novel microsampling protocol. Three visual analog scales on women's experiences of fatigue, anxiety, and pain will also be administered.
Additional data will be collected from the medical record to perform exploratory and hypothesis generating analysis.
- Keywords
- labor dystocia, cesarean delivery, uterine monitoring
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Low-Risk Individuals in Labor | Healthy laboring individuals with a Singleton Term fetus in the Vertex position. Patients requiring medical management of diabetes or hypertension will be excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amniotic Fluid Lactate
Amniotic fluid lactate as measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured once during active labor (6-10cm) after rupture of membranes.
Measured: During active labor (4-10cm) after rupture of membranes
Median power density spectrum of uterine electromyography
Uterine electromyography measured using the Bloomlife Lovelace EMG monitor
Measured: 30 minutes after amniotic fluid collection during active labor (4-10cm) after rupture of membranes
Visual analog scale for fatigue
Participants indicate their level of fatigue on a 100 mm horizontal line anchored by "no fatigue at all" (0) and "the most serious fatigue imaginable" (100). The scale will be administered at the time of amniotic fluid collection.
Measured: At the time of amniotic fluid collection
Amniotic fluid IL-6
Amniotic fluid collected using a volumetric assisted microsampling device.
Measured: At the time of amniotic fluid collection
Secondary outcomes (3)
Capillary Lactate
Capillary lactate measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured within 10 minutes of the amniotic fluid lactate measurement.
Measured: At the time of amniotic fluid collection
Serum Lactate
Serum lactate measured using a POC device and analyzed using a laboratory assay
Measured: At the time of amniotic fluid collection
Serum IL-6
Serum IL-6 measured using a laboratory assay (multiplex)
Measured: At the time of amniotic fluid collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Aug 2023
- Primary completion20 Mar 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor (Obstetrics)--ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Nova Biomedical
- Responsible party
- Sponsor
- Investigators
- Katherine Kissler, PhD, Principal investigator, University of Colorado Anschutz Medical Campus, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251702
- Sponsor's protocol ID
- 19-0307
- Other IDs
- F31NR018582-01
- Acronym
- BUMP
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing can be arranged by contacting the PI