What this study is
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.
What's being tested
- Room light/light bulb
Intervention · DEVICE
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.
Study details
- Official title
- Impact of Light on Labor Progression
- Sponsor
- Michigan State University
- Conditions
- Pregnancy Related · Labor; Poor · Uterine Contractions Weak
- Enrolling
- 100 people
- Starts
- 2025-09-01
- Est. completion
- 2029-09-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 42 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMichigan State University
East Lansing, Michigan, United States
- Hanne Hoffmann, PhD · Contact517 353 1415hanne@msu.edu
Recruiting
Study team
Sponsor
Michigan State University
Study ID STUDY00003410
Principal investigator
Hanne M Hoffmann, PhD
Michigan State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.