Glycemic Observation and Metabolic Outcomes in Mothers and Offspring / Glycemic Profile of Pregnancy Consortium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,179
- 试验地点
- 13
- 主要终点
- Large for gestational age (LGA)
研究概览
简要总结
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.
详细描述
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy outcomes in mothers and their newborns. GO MOMs involves multiple institutions and an anticipated 2179 participants. Participants will attend 4 research study visits: Visit 1 (10w0d-14w0d gestation), Visit 2 (16w0d-20w0d gestation), Visit 3 (24w0d-28w0d gestation), and Visit 4 (32w0d-36w0d gestation). Additional data will be collected at a Delivery Visit and via chart abstraction. Mothers will have a Remote Follow-up call after delivery to collect additional data. At Visits 1-4, a blinded CGM sensor will be placed. Participants will be instructed to wear the sensor for 10 days after which time they will follow instructions to return it to their study site. At Visit 1 (10w0d-14w0d gestation), participants will undergo a 75 g 2-hour (hr) OGTT. At Visit 3 (24w0d-28w0d gestation), participants will undergo a 100 g 3 hr OGTT. Visit 1 will include an extended maternal interview to collect social and demographic, medical history, obstetrical history, surgical history, family medical history, current health and pregnancy, and lifestyle (sleep, alcohol, tobacco use) data. Medical history, alcohol and tobacco use data will be updated at each study visit. Sleep data will be updated at Visit 3 (24w0d-28w0d gestation). Blood and urine samples will also be obtained at each visit for additional laboratory testing and some will be stored for ancillary investigations. At the Delivery Visit, newborn physical measurements including weight, length and skinfolds will be performed. Birthweight at delivery will also be obtained through chart abstraction. Primary statistical analyses will be performed to develop predictive criteria based on CGM and/or OGTT measures at Visit 1 (10w0d-14w0d gestation) along with clinical factors for primary maternal and newborn outcomes. Secondary analyses will further refine predictive models and will evaluate associations of maternal glucose with secondary outcomes and longitudinal modeling of maternal glycemia over the course of pregnancy.
GO MOMs Nutrition Substudy: The GO MOMs Nutrition Study is an observational substudy nested within the GO MOMs parent study. The goal of the study is to describe self-reported dietary components in a diverse cohort of pregnant individuals and to study the relationship between maternal diet and outcomes including maternal glycemia, maternal insulin physiology, infant birth weight, and infant fat mass. Participants will complete 6 dietary recalls via the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool during their pregnancies (Figure). Two will occur at visits and four will be unannounced, meaning they are completed on a random day without advance notice, during CGM wear. In addition, stored samples from all GO MOMs participants at visit 1 and 3 will be assayed for other nutritional markers. Primary statistical analyses will be used to identify associations between dietary carbohydrate content at <22 weeks' gestation and maternal glycemia 24-28 weeks' gestation and neonatal birthweight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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").
排除标准
- •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 investigator
研究组 & 干预措施
Pregnant women less than or equal to 14w0d gestation
干预措施: Observational (Other)
结局指标
主要结局
Large for gestational age (LGA)
时间窗: Delivery
Primary outcome in GO MOMs newborns: Number of newborns who are large for gestational age (LGA), defined as birthweight \>90th percentile for gestational age according to Aris et al. (2019). The first birthweight after delivery obtained from medical chart abstraction will be used for defining the primary LGA outcome.
Gestational diabetes (GDM)
时间窗: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Primary outcome in GO MOMs mothers: Number of mothers diagnosed with gestational diabetes mellitus (GDM) using a 100 g 3 hr OGTT at 24w0d-28w0d gestation according to Carpenter-Coustan criteria (at least two of the timed glucose measurements greater than or equal to the following thresholds: fasting \>= 95 mg/dL, 1 hr \>= 180 mg/dL, 2 hr \>= 155 mg/dL, 3 hr \>= 140 mg/dL).
次要结局
- Hypertension(Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy)
- Neonatal hypoglycemia(Within 30 days after delivery)
- Nutrition Substudy: Insulin secretory response(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Nutrition Substudy: large for gestational age birthweight(Delivery)
- Cesarean delivery(Delivery)
- Preterm birth(Delivery)
- Neonatal birth injury(Delivery)
- Neonatal respiratory morbidity(Within 30 days after delivery)
- Nutrition Substudy: Mean CGM glucose in mothers(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Sum of skinfolds(Within 72 hours after delivery)
- Small for gestational age (SGA)(Delivery)
- Neonatal hyperbilirubinemia(Within 30 days after delivery)
- Shoulder dystocia(Delivery)
- Nutrition Substudy: Percent time above various glycemic thresholds at 24-28 weeks(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Nutrition Substudy: Neonatal fat mass(Within 72 hours of delivery)
- Nutrition Substudy: Mean nocturnal glucose(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Nutrition Substudy: Percent time above various glycemic thresholds at 16-36 weeks(When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant)
- Nutrition Substudy: Insulin resistance(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Nutrition Substudy: gestational diabetes mellitus diagnosis(When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant)
- Nutrition Substudy: Birthweight for gestational age percentile(Delivery)
研究者
Denise Scholtens
Professor
Northwestern University