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

NCT04521972 | Recruiting FDA Device

• 1 other identifier: STUDY00003410
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Nocturnal room light changes uterine contractions in pregnant women

  We will measure how room light during day and night periods impact uterine contractions during pregnancy and labor.

  From confirmation of pregnancy till birth. The study time frame is up to 40 weeks.

Secondary Outcomes (1)

• Nocturnal room light changes melatonin release in pregnant women

  From confirmation of pregnancy till birth. The study time frame is up to 40 weeks.

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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.

Device: Room light/light bulb

Group 2

ACTIVE COMPARATOR

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.

Device: Room light/light bulb

Group 3

EXPERIMENTAL

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

Device: Room light/light bulb

Group 4

EXPERIMENTAL

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.

Device: Room light/light bulb

Interventions

Room light/light bulb 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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: The study is focused on pregnancy and labor, as such only women are include in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You 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 may not qualify 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
• 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

Sponsors & Collaborators

• Michigan State University: lead
• McLaren Health Care: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

Study Officials

• Hanne M Hoffmann, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne M Hoffmann, PhD

CONTACT

858 344 8389; hanne@msu.edu

Robert Seiler, DO

CONTACT

summonerfan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)