Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.

NCT04437576 | Unknown

• 1 other identifier: STUDY00020328
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Labor Onset Biomarkers; Labor Onset; Cervical Dilation

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Characterize latent labor symptoms among nulliparous women in spontaneous labor

  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

  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

  week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU

Other Outcomes (3)

• Change in Basal body temperature comparison in spontaneous labor vs induction

  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

  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

  week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Bloomlife Technologies: collaborator
• Medical Research Foundation, Oregon: collaborator
• OHSU School of Nursing: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Officials

• Ellen Tilden, PhD, CNM

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 18, 2020
• Study Start: September 13, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)