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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorMichigan State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

We will measure how room light during day and night periods change melatonin release during pregnancy and labor.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michigan State University

Lead sponsor

McLaren Health Care

Collaborator