RECRUITING

Testing Effects of Melatonin on Uterine Contractions in Women

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Testing Effects of Melatonin on Uterine Contractions in Women

Quick Facts

Study Start:2023-01-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05358834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * nulliparity, age between 18 and 35,
  2. * BMI\<36 pre-pregnancy,
  3. * ≥40 weeks of pregnancy with a single fetus at time of study.
  4. * pregnancy-associated obstetrical care by nurse midwife or physician associated with MassGeneralBrigham (MGB) (including hospital and community health centers)
  5. * planned admission for delivery at a MGB affiliated institution.
  1. * color blind;
  2. * prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
  3. * a health or pregnancy related condition that might affect melatonin or uterine contractions;
  4. * 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).

Contacts and Locations

Study Contact

Elizabeth B Klerman, MD PhD
CONTACT
617-643-2424
ebklerman@hms.harvard.edu
Shadab A Rahman, PhD
CONTACT
617-525-8830
sarahman@rics.bwh.harvard.edu

Principal Investigator

Elizabeth B Klerman, MD PhD
PRINCIPAL_INVESTIGATOR
MGH

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Elizabeth B Klerman, MD PhD, PRINCIPAL_INVESTIGATOR, MGH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnant Women