All > Melatonin

Daytime melatonin 0.5 mg for Pregnancy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MAPregnancyMelatonin - DietarySupplement
Eligibility
18 - 35
Female
What conditions do you have?
Select

Study Summary

This trialwill explore the connection between melatonin levels and contractions during pregnancy, testing if manipulating melatonin can affect the number of contractions.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 10 hours

10 hours
Daytime: Total number of uterine contractions
4 hours
Nighttime: Total number of uterine contractions

Trial Safety

Safety Progress

1 of 3

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1
Melatonin
1
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Side Effects for

Melatonin
42%Fatigue
39%Early Morning Wakening
36%Daytime drowsiness
11%Dizziness
11%Blurred vision
11%Weakness
11%Nausea
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01114373) in the Melatonin ARM group. Side effects include: Fatigue with 42%, Early Morning Wakening with 39%, Daytime drowsiness with 36%, Dizziness with 11%, Blurred vision with 11%.

Trial Design

5 Treatment Groups

Daytime melatonin 0.5 mg
1 of 5
Daytime melatonin 3.0 mg
1 of 5
Nighttime melatonin 0.5 mg
1 of 5
Daytime melatonin 0.0 mg
1 of 5
Nighttime melatonin 0.0 mg
1 of 5

Experimental Treatment

Non-Treatment Group

120 Total Participants · 5 Treatment Groups

Primary Treatment: Daytime melatonin 0.5 mg · Has Placebo Group · N/A

Daytime melatonin 0.5 mg
DietarySupplement
Experimental Group · 1 Intervention: Melatonin · Intervention Types: DietarySupplement
Daytime melatonin 3.0 mg
DietarySupplement
Experimental Group · 1 Intervention: Melatonin · Intervention Types: DietarySupplement
Nighttime melatonin 0.5 mg
DietarySupplement
Experimental Group · 1 Intervention: Melatonin · Intervention Types: DietarySupplement
Daytime melatonin 0.0 mg
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement
Nighttime melatonin 0.0 mg
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 hours

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,498 Previous Clinical Trials
10,483,065 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,730 Previous Clinical Trials
31,213,604 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,684 Total Patients Enrolled
Elizabeth B Klerman, MD PhDPrincipal InvestigatorMGH
7 Previous Clinical Trials
863 Total Patients Enrolled

Eligibility Criteria

Age 18 - 35 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have never given birth and you are between the ages of 18 and 35.
You are receiving pregnancy-related care from a nurse midwife or physician who is associated with MassGeneralBrigham (MGB), including their hospitals and community health centers.
Your body mass index (BMI) before getting pregnant is less than 36.
You are in your 40th week of pregnancy and expecting only one baby.
You are scheduled to give birth at a hospital affiliated with MGB.
References

Frequently Asked Questions

Is the study population restricted to individuals under 60 years of age?

"This trial has set the age range of participants from 18 to 35 years old. Separately, there are 1 trials for minors and 3 for persons over 65." - Anonymous Online Contributor

Unverified Answer

Are there vacancies still available for participation in this clinical trial?

"Clinicaltrials.gov suggests that enrolment for this trial is ongoing; the experiment was initially published on January 1st, 2023 and was last revised on February 6th of the same year." - Anonymous Online Contributor

Unverified Answer

How many participants has this trial enrolled thus far?

"Indeed, the evidence on clinicaltrials.gov confirms that this study is recruiting participants, with 120 individuals sought from one single location. The trial was first posted in January of 2023 and has been recently updated in February of the same year." - Anonymous Online Contributor

Unverified Answer

Who can sign up for this clinical trial?

"This medical research endeavour is looking for 120 nulliparous women between 18 and 35 years old, with a BMI below 36 before their pregnancy. Furthermore, the subjects should have completed 40 weeks of gestation with one fetus at the time of enrolment, as well as receive obstetrical care from either nurse midwives or physicians affiliated to MassGeneralBrigham (MGB). Finally, they must plan on giving birth in a MGB institution." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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