Labor Onset BiomarkersNCT04437576
Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.
An observational study of Labor Onset Biomarkers and Labor Onset, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The proposed pilot investigation is a prospective, observational study of 300 healthy nulliparous women with spontaneous term labor onset. The specific aims of this study are to: Aim #1: Characterize IL-8 (pro-inflammatory biomarker), basal body temperature, maternal heart rate, and electrical activity of the uterus… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Labor Onset Biomarkers, Labor Onset, Cervical Dilation
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 1 Jun 2021
- Phase
- Observational
- 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 20 to 39 years
- Women only
- Adult
Study population: This is a study of reproductive age women 20-39 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for prenatal care in our outpatient Center for Women's Health Clinics and OHSU Labor and Delivery.
Who may be able to join
- Nulliparous
- Maternal age of at least 20 years of age.
- Maternal age of no greater than 39 years of age.
- Viable, term pregnancy: ≥ 37 weeks gestation at time of signing study consent.
- Able to understand and provide an informed consent.
- Able to understand English.
Who cannot join
- Multiple gestation (i.e., carrying >1 fetus)
- Managing complex comorbidities (e.g., preeclampsia)
- Documented fetal congenital anomalies
- Preterm labor and birth
- Persistent breech fetal position at term
- Fetal death prior to the onset of labor
- Any indication for planned cesarean birth (e.g., placenta previa)
- Induction of labor for medical indication (e.g., oligohydramnios)
Trial locations and contacts
1 site in 1 country.
About this study
The proposed pilot investigation is a prospective, observational study of 300 healthy nulliparous women with spontaneous term labor onset. The specific aims of this study are to:
Aim #1: Characterize IL-8 (pro-inflammatory biomarker), basal body temperature, maternal heart rate, and electrical activity of the uterus prior to spontaneous onset of labor through the onset of active labor among nulliparous women. IL-8 will be quantified weekly, daily basal body temperature, as well as continuous maternal heart rate and electrical activity of the uterus throughout the transition from late pregnancy into active labor.
Read more
Aim #2: Characterize latent labor symptoms among nulliparous women in spontaneous labor. Using Likert scale, childbirth-specific, symptom-specific PROMIS measures,45 and open-ended questions will be quantified and characterize latent labor symptoms (e.g., intensity, frequency) and identify relevant themes.
Aim #3: Characterize trajectories of labor biomarkers and latent labor symptoms across latent labor duration. A modified growth mixture modeling approach to quantify subgroup phenotypes among nulliparous women in spontaneous latent labor will be employed.
Hypothesis 3.1. There will be significant congruence between higher biomarkers (e.g., higher IL-8, more uterine electrical activity) and symptoms that are more intense and frequent.
Hypothesis 3.2. At least two classes of laboring women with distinct trajectories of change in biomarkers and symptoms can be identified and will be associated with cervical dilation at hospital admission.
Exploratory Aim: Characterize biomarkers among nulliparous women with spontaneous labor onset vs. nulliparous women requiring labor induction for post-term gestation. Weekly IL-8, daily basal body temperature, as well as continuous maternal heart rate and electrical activity of the uterus throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation will be quantified.
Exploratory Hypothesis. There will be different biomarker patterns between women with spontaneous labor onset vs. those without.
The Standard descriptive and inferential statistics as well as growth mixture modeling for quantitative aims will be used. The investigators will use thematic development for qualitative aims.
- Conditions
- Labor Onset Biomarkers, Labor Onset, Cervical Dilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery
Measure of IL-8 in serum
Measured: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Changes in Basal body temperature during latent phase of labor to delivery
Measure body temperature first thing every morning until admission to hospital for birth.
Measured: Daily from 37 weeks gestation until admission to hospital for labor
Change in Maternal heart rate during latent phase of labor to delivery
Wearable sensor worn to record heart rate continually.
Measured: Continuously from 37 weeks gestation until admission to hospital for labor
Change in electrical activity of the uterus during latent phase of labor to delivery
Wearable sensor that records signals detected on the surface of the abdomen (e.g. signals generated by the uterus) and movements.
Measured: Continuously from 37 weeks gestation until admission to hospital for labor
Secondary outcomes (3)
Characterize latent labor symptoms among nulliparous women in spontaneous labor
Quantify and characterize latent labor symptoms and identify relevant themes
Measured: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Characterize trajectories of latent labor biomarkers across latent labor duration
Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor
Measured: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Characterize trajectories of latent labor symptoms across latent labor duration
Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor using growth mixture modeling viewing longitudinal change.
Measured: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start13 Sep 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset BiomarkersStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Bloomlife Technologies, Medical Research Foundation, Oregon, OHSU School of Nursing
- Responsible party
- Principal investigator, Ellen Tilden, Oregon Health and Science University
- Investigators
- Ellen Tilden, PhD, CNM, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437576
- Sponsor's protocol ID
- STUDY00020328
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 18 Jun 2020
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.
- ClinicalTrials.gov ID
- NCT04437576
- Acronym / sponsor ID
- STUDY00020328
- Conditions
- Labor Onset Biomarkers, Labor Onset, Cervical Dilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Bloomlife Technologies, Medical Research Foundation, Oregon, OHSU School of Nursing
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 18 Jun 2020 (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.
The proposed pilot investigation is a prospective, observational study of 300 healthy nulliparous women with spontaneous term labor onset. The specific aims of this study are to:
Aim #1: Characterize IL-8 (pro-inflammatory biomarker), basal body temperature, maternal heart rate, and electrical activity of the uterus prior to spontaneous onset of labor through the onset of active labor among nulliparous women. IL-8 will be quantified weekly, daily basal body temperature, as well as continuous maternal heart rate and electrical activity of the uterus throughout the transition from late pregnancy into active labor.
Aim #2: Characterize latent labor symptoms among nulliparous women in spontaneous labor. Using Likert scale, childbirth-specific, symptom-specific PROMIS measures,45 and open-ended questions will be quantified and characterize latent labor symptoms (e.g., intensity, frequency) and identify relevant themes.
Aim #3: Characterize trajectories of labor biomarkers and latent labor symptoms across latent labor duration. A modified growth mixture modeling approach to quantify subgroup phenotypes among nulliparous women in spontaneous latent labor will be employed.
Hypothesis 3.1. There will be significant congruence between higher biomarkers (e.g., higher IL-8, more uterine electrical activity) and symptoms that are more intense and frequent.
Hypothesis 3.2. At least two classes of laboring women with distinct trajectories of change in biomarkers and symptoms can be identified and will be associated with cervical dilation at hospital admission.
Exploratory Aim: Characterize biomarkers among nulliparous women with spontaneous labor onset vs. nulliparous women requiring labor induction for post-term gestation. Weekly IL-8, daily basal body temperature, as well as continuous maternal heart rate and electrical activity of the uterus throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation will be quantified.
Exploratory Hypothesis. There will be different biomarker patterns between women with spontaneous labor onset vs. those without.
The Standard descriptive and inferential statistics as well as growth mixture modeling for quantitative aims will be used. The investigators will use thematic development for qualitative aims.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This is a study of reproductive age women 20-39 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for prenatal care in our outpatient Center for Women's Health Clinics and OHSU Labor and Delivery.
Key inclusion criteria (6 listed)
- Nulliparous
- Maternal age of at least 20 years of age.
- Maternal age of no greater than 39 years of age.
- Viable, term pregnancy: ≥ 37 weeks gestation at time of signing study consent.
- Able to understand and provide an informed consent.
Key exclusion criteria (8 listed)
- Multiple gestation (i.e., carrying >1 fetus)
- Managing complex comorbidities (e.g., preeclampsia)
- Documented fetal congenital anomalies
- Preterm labor and birth
- Persistent breech fetal position at term
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery
Time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Measure of IL-8 in serum
Changes in Basal body temperature during latent phase of labor to delivery
Time frame: Daily from 37 weeks gestation until admission to hospital for labor
Measure body temperature first thing every morning until admission to hospital for birth.
Change in Maternal heart rate during latent phase of labor to delivery
Time frame: Continuously from 37 weeks gestation until admission to hospital for labor
Wearable sensor worn to record heart rate continually.
Change in electrical activity of the uterus during latent phase of labor to delivery
Time frame: Continuously from 37 weeks gestation until admission to hospital for labor
Wearable sensor that records signals detected on the surface of the abdomen (e.g. signals generated by the uterus) and movements.
3 secondary outcomes
Characterize latent labor symptoms among nulliparous women in spontaneous labor
Time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Characterize trajectories of latent labor biomarkers across latent labor duration
Time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Characterize trajectories of latent labor symptoms across latent labor duration
Time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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.
Ellen Tilden, PhD, CNM 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?
An observational study of Labor Onset Biomarkers and Labor Onset, 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 6 inclusion and 8 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 18 Jun 2020. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery (time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU). The study lists 4 primary outcomes in all. 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 18 Jun 2020.