Impact of Light on Labor Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nocturnal room light changes uterine contractions in pregnant women
研究概览
简要总结
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.
详细描述
Overview of study layout
The indicated prenatal visit weeks are approximate time points. The prenatal visit only needs to occur prior to the sample collection time point.
Time point 1 (First interaction with patient). First trimester of pregnancy. Recruiting patients who have an Ob/Gyn appointment to start prenatal care. During this visit we will recruit women with confirmed pregnancy into the study. During the meeting with the Ob/Gyn, the study goals and layout of study will be explained to the patient. The patient will not be informed about the expected outcome of nocturnal light on uterine contractions and labor progression.
The patient will be provided with the consent forms and given time to read and ask questions about the forms prior to signing. If the patient desires to read the consent form at home, and enroll later, that is also possible.
After enrolling in the study, the patient will be given the below information to complete during week 11 of pregnancy in their home:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Continued use of weight loss medication including OTC and dietary supplements for weight loss (e.g., Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange) Other Exclusion Criteria
- •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
研究组 & 干预措施
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.
干预措施: Room light/light bulb (Device)
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.
干预措施: Room light/light bulb (Device)
Group 3
Natural non-augmented labor with reduced or red room lights.
干预措施: Room light/light bulb (Device)
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.
干预措施: Room light/light bulb (Device)
结局指标
主要结局
Nocturnal room light changes uterine contractions in pregnant women
时间窗: From confirmation of pregnancy till birth. The study time frame is up to 40 weeks.
We will measure how room light during day and night periods impact uterine contractions during pregnancy and labor.
次要结局
- Nocturnal room light changes melatonin release in pregnant women(From confirmation of pregnancy till birth. The study time frame is up to 40 weeks.)
研究者
Hanne M Hoffmann
Assistant Professor
Michigan State University