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| Name | Class |
|---|---|
| Bloomlife Technologies | UNKNOWN |
| Medical Research Foundation, Oregon | OTHER |
| OHSU School of Nursing | UNKNOWN |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery | Measure of IL-8 in serum | 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. | 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. | 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. | Continuously from 37 weeks gestation until admission to hospital for labor |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize latent labor symptoms among nulliparous women in spontaneous labor | Quantify and characterize latent labor symptoms and identify relevant themes | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Basal body temperature comparison in spontaneous labor vs induction | Quantified weekly basal body temperature comparison 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. | week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Tilden, PhD, CNM | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Portland | Oregon | 97239 | United States |
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Serum
Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor |
| 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. | week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU |
| Changes in continuous maternal heart rate comparison in spontaneous labor vs induction | Quantified maternal heart rate comparison 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. | week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU |
| Changes in IL-8 comparison in spontaneous labor vs induction | Quantified weekly IL-8 comparison 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. | week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU |