What is the Best Time for Gestational Diabetes Screening?
By Matthew Garza
Help researchers evaluate and improve gestational diabetes screening and diagnosis – share this clinical study with anyone you know who is newly pregnant to see if they are eligible to join.
Clinical Trials Identifier: NCT04860336
Trial Name: Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs)
Diabetes Type: Gestational Diabetes
What is the trial testing?
The GO MOMs study is an observational study that will use pregnant participants’ glucose data (from a continuous glucose monitor or CGM) to look at how glucose levels change throughout a pregnancy. Researchers hope to see how glucose levels relate to the traditional gestational diabetes screening and diagnosis process, which occurs between weeks 24 and 28 of a pregnancy, to improve the screening process.
The study is enrolling 2,150 pregnant participants in various centers across the US. Participants will attend four research study visits, a delivery visit, and a remote follow-up call after delivery. The four study visits will be spaced out between weeks 10 to 36 of the pregnancy. At each visit, a healthcare professional will place a blinded CGM on the mother, for ten days of glucose data collection. With blinded CGM, participants cannot actively check their own glucose data in real-time; instead, their healthcare team will be able to see and evaluate their data after the ten-day period.
What is the trial measuring?
The researchers will be collecting CGM data at various points throughout the pregnancy and looking at participants’ glycemic profiles. They will gather additional data, including medical history, surgical history, demographic information, lifestyle data, blood and urine samples, and newborn physical measurements at the delivery visit. Researchers will conduct a follow-up call after delivery to collect any final data.
The study is primarily measuring the number of participants who are diagnosed with gestational diabetes between 24 and 28 weeks into the pregnancy and the number of children who are born large for gestational age (LGA). It will measure some other data including hypertension, cesarean deliveries, babies born small for gestational age (SGA), preterm births, and neonatal hypoglycemia, birth injury, and other complications.
Why is the trial new and important?
Gestational diabetes is generally diagnosed between weeks 24 to 28 of a person’s pregnancy. However, the study is looking to understand if diabetes can be diagnosed earlier into a pregnancy, which might allow the mother to manage blood sugar levels more effectively to avoid some of the lasting harm that can be caused to the mother and the baby.
GO MOMs hopes to build on the findings of a prior study (HAPO and its follow-up study) which found that mothers with elevated glucose levels during pregnancy (even if they did not reach the levels to diagnose gestational diabetes) were more likely to develop prediabetes and type 2 diabetes years later. The children born to women with elevated glucose levels during pregnancy were more likely to have obesity or challenges processing glucose a decade after being born.
This study hopes to evaluate and improve gestational diabetes screening and diagnosis by studying the changes that occur in glucose metabolism throughout the pregnancy. Researchers may be able to identify early indicators of gestational diabetes and determine the best time to screen for and diagnose it –improving a person’s ability to manage their blood sugar levels and avoid the harmful effects of high glucose during pregnancy.
The trial will last from time of enrollment (between 10-14 weeks into your pregnancy) until delivery, with one follow-up call after delivery.
Are you interested?
You may be eligible to participate in this study if you:
Are at least 18 years old.
Are between weeks 10 and 14 of your pregnancy at your first study visit.
Are willing and able to wear a CGM at various points throughout the study.
Can deliver your baby at one of the GO MOMs-affiliated hospitals (listed below).
Do not have pre-existing diabetes at enrollment (A1C greater than 6.5%, fasting glucose greater than 126 mg/dL).
You can find a full list of inclusion and exclusion criteria here.
Trial location and contact information:
This trial does require you to attend in-person study visits and have your delivery at one of the GO MOMs-affiliated hospitals. Take a look below for participating institutions and the contact information for each. Note that not all locations are actively recruiting right now.
New Haven, Connecticut, United States, 06511
Contact: Uma Reddy, MD, MPH, 203-785-5855, firstname.lastname@example.org
Contact: Jennifer Sherr, MD, PhD, 203-785-5831, email@example.com
Kaiser Permanente - Hawaii
Honolulu, Hawaii, United States, 96817
Contact: Teresa Hillier, MD, MS, 503-335-2478, firstname.lastname@example.org
Chicago, Illinois, United States, 60611
Contact: William Grobman, MD, MBA, 312-472-4685, email@example.com
Contact: Denise Scholtens, PhD, 312-503-7261, firstname.lastname@example.org
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Contact: Alexandra Spadola, MD, 617-636-2382, email@example.com
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Camille Powe, MD, 617-643-4684, Camille.Powe@mgh.harvard.edu
New York, New York, United States, 10032
Contact: Noelia Zork, MD, 347-514-0034, firstname.lastname@example.org
Kaiser Permanente - Northwest
Portland, Oregon, United States, 97227
Contact: Erin LeBlanc, 503-528-3996, email@example.com
Magee Womens Research Institute & Foundation
Pittsburgh, Pennsylvania, United States, 15213
Contact: Francesca Facco, MD, 412-641-5406, firstname.lastname@example.org
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Contact: Erika Werner, MD, MS, 401-274-1122 ext 47443, email@example.com
Contact: Dwight Rouse, MD, MSPH, DRouse@Wihri.org