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.

Study Overview

• Status: Unknown
• Conditions: Labor Onset; Cervical Dilation; Labor Onset Biomarkers

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

1. Nulliparous
2. Maternal age of at least 20 years of age.
3. Maternal age of no greater than 39 years of age.
4. Viable, term pregnancy: ≥ 37 weeks gestation at time of signing study consent.
5. Able to understand and provide an informed consent.
6. Able to understand English.

Exclusion Criteria:

1. Multiple gestation (i.e., carrying >1 fetus)
2. Managing complex comorbidities (e.g., preeclampsia)
3. Documented fetal congenital anomalies
4. Preterm labor and birth
5. Persistent breech fetal position at term
6. Fetal death prior to the onset of labor
7. Any indication for planned cesarean birth (e.g., placenta previa)
8. Induction of labor for medical indication (e.g., oligohydramnios)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Medical Research Foundation, Oregon; Bloomlife Technologies; OHSU School of Nursing
• Investigators: Principal Investigator: Ellen Tilden, PhD, CNM, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: STUDY00020328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No