Pregnant WomenMelPregNCT05358834
Testing Effects of Melatonin on Uterine Contractions in Women
A study testing Melatonin in people with Pregnant Women, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- nulliparity, age between 18 and 35,
- BMI<36 pre-pregnancy,
- ≥38 weeks of pregnancy with a single fetus at time of study.
Who cannot join
- color blind;
- prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
- a health or pregnancy related condition that might affect melatonin or uterine contractions;
- medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil).
- Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Elizabeth B Klerman, MD PhD, 617-732-5500 ext. 33948, ebklerman@hms.harvard.edu
Elizabeth Klerman, MD PhD
About this study
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).
- Conditions
- Pregnant Women
- Being tested
- Melatonin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Oral melatonin administered as a single pill.
PlaceboDietary supplement
Oral placebo administered as a single pill.
| Study group | Role | What they receive |
|---|---|---|
| Daytime melatonin 0.0 mg | Placebo comparator | Daytime melatonin 0.0 mg Receives: Dietary Supplement: Placebo |
| Daytime melatonin 0.5 mg | Experimental | Daytime melatonin 0.5 mg Receives: Dietary Supplement: Melatonin |
| Daytime melatonin 3.0 mg | Experimental | Daytime melatonin 3.0 mg Receives: Dietary Supplement: Melatonin |
| Nighttime melatonin 0.0 mg | Placebo comparator | Nighttime melatonin 0.0 mg Receives: Dietary Supplement: Placebo |
| Nighttime melatonin 0.5 mg | Experimental | Nighttime melatonin 0.5 mg Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime: Total number of uterine contractions
Daytime: Total number of uterine contractions
Measured: 10 hours
Nighttime: Total number of uterine contractions
Nighttime: Total number of uterine contractions
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jan 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elizabeth Klerman MD PhD, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358834
- Sponsor's protocol ID
- 2021P002926
- Other IDs
- R01HD107064
- Acronym
- MelPreg
- Status last verified
- May 2026
- First submitted
- 28 Apr 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per the NIH Policy on Data Sharing, we will make the datasets available to other investigators following publication of the final study results. We will make data available on a public database, such as the NIH-supported National Sleep Research Resource (NSRR; sleepdata.org). Outside investigators should submit their request in writing to the PI. Additional details below in Access Criteria
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Effects of Melatonin on Uterine Contractions in Women
- ClinicalTrials.gov ID
- NCT05358834
- Acronym / sponsor ID
- MelPreg / 2021P002926
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Daytime melatonin 0.0 mg | Placebo comparator | Dietary Supplement: PlaceboDaytime melatonin 0.0 mg |
| Daytime melatonin 0.5 mg | Experimental | Dietary Supplement: MelatoninDaytime melatonin 0.5 mg |
| Daytime melatonin 3.0 mg | Experimental | Dietary Supplement: MelatoninDaytime melatonin 3.0 mg |
| Nighttime melatonin 0.0 mg | Placebo comparator | Dietary Supplement: PlaceboNighttime melatonin 0.0 mg |
| Nighttime melatonin 0.5 mg | Experimental | Dietary Supplement: MelatoninNighttime melatonin 0.5 mg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- nulliparity, age between 18 and 35,
- BMI<36 pre-pregnancy,
- ≥38 weeks of pregnancy with a single fetus at time of study.
Key exclusion criteria (5 listed)
- color blind;
- prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
- a health or pregnancy related condition that might affect melatonin or uterine contractions;
- medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil).
- Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninOral melatonin administered as a single pill. | Dietary supplement | Daytime melatonin 0.5 mg, Daytime melatonin 3.0 mg, Nighttime melatonin 0.5 mg |
| PlaceboOral placebo administered as a single pill. | Dietary supplement | Daytime melatonin 0.0 mg, Nighttime melatonin 0.0 mg |
Primary outcome
Daytime: Total number of uterine contractions
Time frame: 10 hours
Daytime: Total number of uterine contractions
Nighttime: Total number of uterine contractions
Time frame: 4 hours
Nighttime: Total number of uterine contractions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. Per the NIH Policy on Data Sharing, we will make the datasets available to other investigators following publication of the final study results. We will make data available on a public database, such as the NIH-supported National Sleep Research Resource (NSRR; sleepdata.org). Outside investigators should submit their request in writing to the PI. Additional details below in Access Criteria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth B Klerman, MD PhD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Pregnant Women, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth B Klerman, MD PhD (617-643-2424, ebklerman@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime: Total number of uterine contractions (time frame: 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.