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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Room light/light bulb
DeviceRoom 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Michigan State University
Lead sponsor
McLaren Health Care
Collaborator