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

Labor Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04437576
• Other study ID #: STUDY00020328
• Status: Active, not recruiting
• Start date: September 13, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Dilation
• Labor Onset
• Labor Onset Biomarkers

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	Bloomlife Technologies, Medical Research Foundation, Oregon, OHSU School of Nursing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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