Labor Onset Clinical Trial
Official title:
Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.
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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