Changing room lighting to slow or speed labor contractions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will recruit pregnant participants early in prenatal care and collect sleep/activity questionnaires and timed saliva samples taken under different lighting conditions to measure melatonin. Participants will use a home uterine contraction monitor, report lighting and contraction data, and adapt room lighting at prescribed times at home and in hospital (bright lights to halt, reduced/red lights to promote). The study links lighting, melatonin measures, contraction patterns, and labor outcomes such as success of induction and vaginal birth versus cesarean delivery. Data will be collected at scheduled prenatal visits and around the time of labor to compare outcomes under different lighting conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Michigan State University
  East Lansing, Michigan, United States Recruiting

Study contacts

• Principal investigator: Hanne M Hoffmann, PhD — Michigan State University
• Study coordinator: Hanne M Hoffmann, PhD
• Email: hanne@msu.edu
• Phone: 858 344 8389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.