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Hormone Therapy

Melatonin for Uterine Contractions in Pregnancy (MelPreg Trial)

N/A
Recruiting
Led By Elizabeth B Klerman, MD PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥40 weeks of pregnancy with a single fetus at time of study
Be between 18 and 65 years old
Must not have
Prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 hours

Summary

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

Who is the study for?
This trial is for first-time pregnant women aged 18-35, with a BMI under 36 before pregnancy, and at least 40 weeks into a single-fetus pregnancy. They must be receiving care from MassGeneralBrigham and planning to deliver at an MGB-affiliated institution. Women taking certain medications or with conditions affecting sleep, melatonin levels, or uterine contractions are excluded.
What is being tested?
The study tests if melatonin affects uterine contractions in full-term pregnant women. It involves giving exogenous melatonin during the day when natural levels are low and in the evening under light that suppresses natural melatonin production. Participants will either receive actual melatonin or a placebo.
What are the potential side effects?
Melatonin may cause side effects such as drowsiness, morning grogginess, small changes in blood pressure, and increased risk of bleeding when taken with certain medications like anticoagulants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 40 weeks pregnant with one baby.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not taking medication that affects my sleep or body clock.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daytime: Total number of uterine contractions
Nighttime: Total number of uterine contractions

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Nighttime melatonin 0.5 mgExperimental Treatment1 Intervention
Nighttime melatonin 0.5 mg
Group II: Daytime melatonin 3.0 mgExperimental Treatment1 Intervention
Daytime melatonin 3.0 mg
Group III: Daytime melatonin 0.5 mgExperimental Treatment1 Intervention
Daytime melatonin 0.5 mg
Group IV: Nighttime melatonin 0.0 mgPlacebo Group1 Intervention
Nighttime melatonin 0.0 mg
Group V: Daytime melatonin 0.0 mgPlacebo Group1 Intervention
Daytime melatonin 0.0 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,504 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,015 Previous Clinical Trials
13,309,240 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,766 Total Patients Enrolled

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05358834 — N/A
Pregnancy Research Study Groups: Nighttime melatonin 0.0 mg, Daytime melatonin 3.0 mg, Daytime melatonin 0.5 mg, Daytime melatonin 0.0 mg, Nighttime melatonin 0.5 mg
Pregnancy Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05358834 — N/A
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358834 — N/A
~56 spots leftby Jun 2026
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