Clinical trial NCT05388643: Early Detection of Gestational Diabetes Mellitus in Pregnancy
Official title: Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Pregnancy, High Risk
Keywords: Pregnancy
Gestational Diabetes
Screening
Maternal Outcomes
Neonatal Outcomes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-05-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.
Primary purpose: SCREENING

Brief summary: The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Detailed description: Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Eligibility criteria: Inclusion Criteria:

* 1) age greater than or equal to 18 years old,
* 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
* 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
* 4) able and willing to provide informed consent,
* 5) English or Spanish speaking, and
* 6) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion Criteria:

* 1) known diagnosis of pre-existing pregestational diabetes,
* 2) plan to receive prenatal care or deliver outside of UMMHC,
* 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
* 4) systemic steroid use.

Primary outcomes:
measure: Gestational Diabetes Mellitus
timeFrame: In pregnancy (24-28 weeks gestation)
Secondary outcomes:
measure: Mode of Delivery
timeFrame: At Birth
measure: Neonatal Birthweight
timeFrame: At Birth
measure: Number of Participants with Shoulder Dystocia
timeFrame: At Birth
measure: Number of participants with brachial plexus injury
timeFrame: At Birth
measure: APGAR Score
timeFrame: At Birth
measure: Neonatal Intensive Care Unit Admission
timeFrame: At delivery and within first 2 days of life
measure: Gestational Age at Delivery
timeFrame: At Birth
measure: Patient Satisfaction with Diabetes Screening Method
timeFrame: Postpartum day 1 after birth
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Gianna Wilkie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13.
citation: Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28.