Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (NCT04860336) | Clinical Trial Compass
CompletedNot Applicable
Glycemic Observation and Metabolic Outcomes in Mothers and Offspring
United States2,179 participantsStarted 2021-04-01
Plain-language summary
The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Maternal age \>=18 at consent
* Singleton gestation
* 10w0d-14w0d gestation at the time of the Visit 1 OGTT and CGM placement according to study dating criteria
* Conceived using own oocyte
* Willing and able to wear CGM as directed and adhere to CGM instructions
* Planning to deliver at GO MOMs-affiliated hospital (see list of accrual sites in the protocol section "Key Roles and Contact Information").
Exclusion Criteria:
* Pre-existing diabetes at enrollment
* Currently self-monitoring blood glucose
* Current use of medication with glycemic effects
* Fetal malformation evident at or before enrollment that is likely lethal. This includes, but is not limited to, malformations such as anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, and encephalocele
* Known fetal aneuploidy based on chorionic villus sampling
* Participation in other research study that may modify glycemic profile or study outcomes
* History of bariatric surgery
* Extensive skin changes or diseases making CGM sensor use problematic
* Significant allergy to adhesive
* Previous participation in GO MOMs
* Current bulimia or anorexia nervosa
* Overnight shift work that alters the sleep/wake periods
* Hemoglobin A1c \>= 6.5%, fasting glucose \>= 126 mg/dL or 2 hr glucose \>= 200 mg/dL noted during OGTT at 10w0d-14w0d gestation
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the site invest…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gestational diabetes (GDM)
Timeframe: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant