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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 hours
Awards & highlights

MelPreg Trial 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.Check my eligibility
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.See study design
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.

MelPreg Trial 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.

MelPreg Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

MelPreg Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Nighttime melatonin 0.5 mgExperimental Treatment1 Intervention
Group II: Daytime melatonin 3.0 mgExperimental Treatment1 Intervention
Group III: Daytime melatonin 0.5 mgExperimental Treatment1 Intervention
Group IV: Nighttime melatonin 0.0 mgPlacebo Group1 Intervention
Group V: Daytime melatonin 0.0 mgPlacebo Group1 Intervention
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
1,616 Previous Clinical Trials
11,470,828 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,935 Previous Clinical Trials
13,198,521 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,677 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing Effects of Melatonin on Uterine Contractions in Women
Elizabeth Klerman MD PhD 2023. "Testing Effects of Melatonin on Uterine Contractions in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358834.
All > Womens Health > Melatonin
~76 spots leftby Jun 2026
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