NCT04521972 · Michigan State University
Impact of Room Light on Uterine Contractions and Labor Progression in Pregnancy
What this study is about
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 labor is to achieve a vaginal birth, however in almost 40% of first-time mothers it fails.
View original scientific description
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 labor is to achieve a vaginal birth, however in almost 40% of first-time mothers it fails. Failed labor inductions require a caesarean delivery, which is associated with a vast range of adverse effects for both the mother and her baby. In this application we propose that a simple manipulation of room light will increase the success of vaginal birth through the use of optimal room light settings (halting labor=lights ON, promoting labor=reduced room light/red room light). A sparse literature has shown that the hormone melatonin might be an important hormone to consider during late pregnancy and labor. Pineal melatonin release is only released in darkness at night, where nocturnal light such as room light, suppress pineal melatonin release, reducing uterine contractions (Olcese et al 2013, https://pubmed.ncbi.nlm.nih.gov/22556015/, Rahman et al 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6453747/). Melatonin receptor become upregulated in the pregnant myometrium (uterine smooth muscle), and a small study in women having preterm birth, showed a high expression of melatonin receptor, at a gestational week where women not having preterm uterine contractions, had low levels of melatonin receptor, suggesting that premature increase in myometrium melatonin receptor might in some women be associated with preterm labor and birth (Olcese et al 2013, https://pubmed.ncbi.nlm.nih.gov/22556015/). This study will address how room light impacts melatonin release and uterine contractions in healthy pregnant women.
Interventions
DEVICE
Room light/light bulb
Room light will be ON/OFF or red light used in the room. Reducing/eliminating light in the room in the evening and night is expected to allow the natural release of melatonin, which is thought to promote uterine contractions in late pregnancy.
Primary outcome measures
Nocturnal room light changes uterine contractions in pregnant women
Time frame: From confirmation of pregnancy till birth. The study time frame is up to 40 weeks.
We will measure how room light during day and night periods impact uterine contractions during pregnancy and labor.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- East Lansing, Michigan
Collaborators
McLaren Health Care
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2025 · Source of record for eligibility and locations