Recruiting

Room Light & Melatonin

Sponsor:

Michigan State University

Code:

NCT04521972

Conditions

Pregnancy Related

Labor; Poor

Uterine Contractions Weak

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Accepted

Interventions

Room light/light bulb

Study Details

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 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.

Conditions

Pregnancy Related

Labor; Poor

Uterine Contractions Weak

Study ID

NCT04521972

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Group 1

Natural non-augmented labor with room lights ON. This is what is currently done in the hospital, and thus does not change any current medical practices.

active comparator: Group 2

Augmented labor with room lights ON. This group will be a subgroup of Group 1 (Natural non-augmented labor with room lights ON), as labor-augmentation cannot be planned for until the patient is in labor or labor needs to be augmented for medical reasons.

experimental: Group 3

Natural non-augmented labor with reduced or red room lights.

experimental: Group 4

Augmented labor with reduced or red room lights. This group will be a subgroup of Group 3, as augmented labor cannot be planned for until the patient is in labor or labor needs to be augmented for medical reasons.

Interventions

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Hanne M Hoffmann, PhD

858 344 8389hanne@msu.edu

Robert Seiler, DO

summonerfan@gmail.com

Locations

Michigan State University

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

Hanne Hoffmann, PhD

517 353 1415hanne@msu.edu

More Information

Sponsor

Michigan State University

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michigan State University on 2025-09-18.