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

Part of paid clinical trials in East Lansing, Michigan.

Sponsor
Michigan State University
Study ID
NCT04521972
Status
Recruiting
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Conditions

  • Labor; Poor
  • Pregnancy Related
  • Uterine Contractions Weak

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Michigan State UniversityEast LansingMichigan48824
Hanne Hoffmann, PhD
[email protected]
517 353 1415

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By research site
Michigan State University· East Lansing, MI

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