RECRUITING

Impact of Room Light on Uterine Contractions and Labor Progression in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Impact of Light on Labor Progression

Quick Facts

Study Start:2025-09-01
Study Completion:2029-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04521972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 42 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are pregnant
  2. * Are 18-42 years old
  3. * Medically cleared for participation by Medical Investigator
  4. * Willingness to allow the study access to information in the participant's medical record
  5. * Willingness to be notified of incidental findings from study procedures
  6. * Willingness to measure and report on lighting conditions during specified time periods
  7. * Willingness to use a uterine contraction home monitor system, and report results
  8. * Willingness to adapt lighting during studies in home and/or hospital
  9. * Willingness to wear blue-filter glasses if requested
  10. * Willingness to report use of melatonin (for sleep)
  11. * Willingness to stop melatonin use if requested
  12. * Pre-pregnancy BMI \>36kg/m2
  13. * HIV or AIDS (self-reported)
  14. * Severe anemia (hemoglobin \<8g/dL and/or hematocrit \<24%)
  15. * History or current psychotic disorder or diagnosis of a current major depressive episode or bipolar disorder
  16. * 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
  17. * 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
  18. * Recent history of or currently smoking, drinking alcohol or abusing drugs (prescription or recreational)
  19. * 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
  20. * Planned termination of pregnancy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Hanne M Hoffmann, PhD
CONTACT
858 344 8389
hanne@msu.edu
Robert Seiler, DO
CONTACT
summonerfan@gmail.com

Principal Investigator

Hanne M Hoffmann, PhD
PRINCIPAL_INVESTIGATOR
Michigan State University

Study Locations (Sites)

Michigan State University
East Lansing, Michigan, 48824
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Hanne M Hoffmann, PhD, PRINCIPAL_INVESTIGATOR, Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2029-09-01

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2029-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Labor; Poor
  • Uterine Contractions Weak