Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04521972 |
| Other study ID # |
STUDY00003410 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2024 |
| Est. completion date |
September 1, 2029 |
Study information
| Verified date |
April 2024 |
| Source |
Michigan State University |
| Contact |
Hanne M Hoffmann, PhD |
| Phone |
858 344 8389 |
| Email |
hanne[@]msu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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:
1. Sleep, activity and saliva sample questionnaires (printout).
2. Tubes and cooler to collect two saliva samples at home:
1. Sample 1 is collected 0-3h after sunset
2. Sample 2 is collected 0-3h after sunset in darkness
3. Sample 3 is collected 0-3h after sunset with lights ON
3. Note: Questionnaires are filled on the day of saliva collection. Patients will return
the frozen saliva samples and questionnaires at their next in person Ob/Gyn visit or
when they come to the Hoffmann laboratory in the third trimester.
Time point 2. Week 20-22 of pregnancy, in person Ob/Gyn prenatal care visit.
During visit with Ob/Gyn the patient will be given the below information to complete during
week 20-22 of pregnancy in their home:
1. Sleep, activity and saliva sample questionnaires (printout).
2. Tubes and cooler to collect two saliva samples at home:
1. Sample 1 is collected 0-3h after sunset
2. Sample 2 is collected 0-3h after sunset in darkness
3. Sample 3 is collected 0-3h after sunset with lights ON
3. Note: Questionnaires are filled in the day of saliva collection. Patients will return
the frozen saliva samples and questionnaires at their next in person Ob/Gyn visit or
when they come to the Hoffmann laboratory in the third trimester.
Time point 3. Week 28 of pregnancy-assigning patients into study groups. During the prenatal
visit around week 28, the desired birth plan will be discussed with the patient. During this
meeting, the patient will not know what group they are assigned, nor how we expect the light
conditions to impact labor progression. The primary goal of this discussion is to determine
if the patient is anticipating a planned C-section.
The five study groups patients are assigned to are as follows:
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.
Group 2: Augmented labor with room lights ON. This group will be a subgroup of Group 1, as
labor-augmentation cannot be planned for until the patient is in labor or labor needs to be
augmented for medical reasons.
Group 3: Natural non-augmented labor with reduced or red room lights. 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.
Group 5: C-section. Scheduled and emergency C-sections. Uterine samples will be collected in
this group for ex vivo studies.
Group assignments will be achieved through randomization as follows.
1. Women anticipating a C-section are assigned to group 5.
2. Women anticipating a vaginal birth are randomly assigned to Group 1 and Group 3. This
will allow to have ½ women going through labor with lights ON, and ½ the women going
through labor with reduced room lights.
Note On a monthly basis, we will evaluate the number of women who have given birth in Groups
1-5. Based on this we will readjust group assignments of women entering the study, to assure
comparable group sizes in groups 1-5 to the greatest degree possible.
Time point 4. Third trimester: Weeks 32-34 of pregnancy We will schedule 2 appointments
during weeks 32-34 of pregnancy where the women are able to come to the Hoffmann laboratory
at MSU. One appointment will take place around sunset and be of a duration of 2-3h, starting
around 7-8PM. The second appointment will take place in the morning between 8AM and 12PM.
This appointment will be of ~ 90 min.
During each of these visits at the Hoffmann laboratory the study participants will:
1. Be placed in the study room with a specific room light condition (bright white light or
dim red light).
2. Study participants will fill out the sleep, activity and saliva sample questionnaires.
3. Study participants will have their uterine contractions measured for 60 min at the
morning appointment and for 120-150 min at the evening appointment.
For details of this visit see Annex 1 (last page of this document)
Time point 5. Third trimester: Weeks 38-40 We will schedule 2 appointments during weeks 38-40
of pregnancy where the women are able to come to the Hoffmann laboratory at MSU. One
appointment will take place around sunset and be of a duration of 2-3h, starting around
7-8PM. The second appointment will take place in the morning between 8AM and 12PM. This
appointment will be of ~ 90 min.
During each of these visits at the Hoffmann laboratory the study participants will:
1. Be placed in the study room with a specific room light condition (bright white light or
dim red light).
2. Study participants will fill out the sleep, activity and saliva sample questionnaires.
3. Study participants will have their uterine contractions measured for 60 min at the
morning appointment and for 120-150 min at the evening appointment.
For details of this visit see Annex 1 (last page of this document)
Time point 6. Evaluate labor progression and duration in rooms with lights ON and reduced
light.
When the study participant is admitted to the hospital in labor, the following steps will be
done:
- Room light will be adapted as indicated in patient chart, and room light-intensity
measured.
- Continuously record uterine contractions.
- Collect saliva sample at admission, and every 2 h thereafter until 6h after birth.
Additional steps for women having a C-section When a woman is scheduled to have a C-section
(planned or emergency), Dr. Hoffmann is notified by phone or text to 858 344 8389 at the time
of C-section scheduling. After delivery of the infant by C-section and removal of the
placenta, a full-thickness myometrial sample is removed from the superior edge of the
transverse uterine incision. The wedge-shaped sample, obtained by sharp dissection with a
curved Mayo scissors, is approximately 1 cm wide and 5 cm long. The samples will immediately
be placed in sterile containers and collected by a Hoffmann laboratory member for transport
to MSU where they will be stored in the -80C freezer and used for uterine contraction
analysis The myometrium sample is placed in a deidentified numbered tube and handed over to
experimenter to allow processing. Dr. Hoffmann or a participating Hoffmann laboratory member
will come to the hospital to collect the myometrium sample within 90 min after C-section
completion.
In home delivery In the scenario of home delivery, all data points prior to delivery will be
included in the study. Home delivery will only impact the last study time point, as all data
collections prior to delivery are the same for all the study groups.
