Actively Recruiting

Phase Not Applicable
Age: 18Years - 42Years
FEMALE
Healthy Volunteers
NCT04521972

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

Led by Michigan State University · Updated on 2025-09-18

100

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

M

Michigan State University

Lead Sponsor

M

McLaren Health Care

Collaborating Sponsor

AI-Summary

What this Trial 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. 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

Official Title

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

Who Can Participate

Age: 18Years - 42Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 to 42 years
  • Medically cleared for participation by a medical investigator
  • Willing to allow study access to medical records
  • Willing to be informed of incidental findings from study procedures
  • Willing to measure and report lighting conditions during specified times
  • Willing to use and report results from a home uterine contraction monitor
  • Willing to adjust lighting during home and/or hospital studies
  • Willing to wear blue-filter glasses if requested
  • Willing to report melatonin use for sleep
  • Willing to stop melatonin use if requested
Not Eligible

You will not qualify if you...

  • Pre-pregnancy BMI greater than 36 kg/m2
  • HIV or AIDS (self-reported)
  • Severe anemia with hemoglobin less than 8 g/dL and/or hematocrit less than 24%
  • History or current psychotic disorder, major depressive episode, or bipolar disorder
  • Current use of medications like metformin, systemic steroids, antipsychotics, anti-seizure drugs, mood stabilizers, or ADHD medications that affect body weight
  • Continued use of weight loss medications or dietary supplements
  • Recent or current smoking, alcohol use, or drug abuse
  • Plans to move out of the study area within the next year or to be away for more than 8 weeks
  • Planned termination of pregnancy

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Trial Site Locations

Total: 1 location

1

Michigan State University

East Lansing, Michigan, United States, 48824

Actively Recruiting

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Research Team

H

Hanne M Hoffmann, PhD

CONTACT

R

Robert Seiler, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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