NCT04437576

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

Status unknown Last updated 18 June 2020

What this trial tests

trial in Labor Onset Biomarkers in 300 participants. Status unknown.

Timeline

13 September 2019

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Oregon Health and Science University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	13 September 2019
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Conditions studied

• Labor Onset Biomarkers — all drugs for Labor Onset Biomarkers →
• Labor Onset — all drugs for Labor Onset →
• Cervical Dilation — all drugs for Cervical Dilation →

Sponsor

Oregon Health and Science University

Who can join

Adults 20 to 39, female only, with Labor Onset Biomarkers or Labor Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.