Status:
RECRUITING
Impact of Room Light on Uterine Contractions and Labor Progression in Pregnancy
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
McLaren Health Care
Conditions:
Pregnancy Related
Labor; Poor
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief Summary
Today it remains a challenge to successfully both halt and induce labor progression. Induction of labor is a common obstetric intervention that 1 in 4 women will experience. The goal of induction of l...
Detailed Description
Overview of study layout The indicated prenatal visit weeks are approximate time points. The prenatal visit only needs to occur prior to the sample collection time point. Time point 1 (First interac...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Are pregnant
- Are 18-42 years old
- Medically cleared for participation by Medical Investigator
- Willingness to allow the study access to information in the participant's medical record
- Willingness to be notified of incidental findings from study procedures
- Willingness to measure and report on lighting conditions during specified time periods
- Willingness to use a uterine contraction home monitor system, and report results
- Willingness to adapt lighting during studies in home and/or hospital
- Willingness to wear blue-filter glasses if requested
- Willingness to report use of melatonin (for sleep)
- Willingness to stop melatonin use if requested
- Exclusion criteria
- Pre-pregnancy BMI \>36kg/m2
- HIV or AIDS (self-reported)
- Severe anemia (hemoglobin \<8g/dL and/or hematocrit \<24%)
- History or current psychotic disorder or diagnosis of a current major depressive episode or bipolar disorder
- Current use of one or more of the following medications: metformin, systemic steroids, antipsychotic agents (e.g., Abilify, Haldol, Risperdal, Seroquel, Zyprexa), anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra), medications for ADHD including amphetamines and methylphenidate
- Continued use of weight loss medication including OTC and dietary supplements for weight loss (e.g., Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange) Other Exclusion Criteria
- Recent history of or currently smoking, drinking alcohol or abusing drugs (prescription or recreational)
- Plans to move out of the study area within the next year or plans to be out of the study area for more than 8 weeks in the next 12 months
- Planned termination of pregnancy
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04521972
Start Date
September 1 2025
End Date
September 1 2029
Last Update
September 18 2025
Active Locations (1)
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1
Michigan State University
East Lansing, Michigan, United States, 48824