Early Detection of Gestational Diabetes Mellitus in Pregnancy

Pregnancy, High Risk Clinical Trial

Official title:

Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05388643
• Other study ID #: STUDY00000390
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Gianna L Wilkie, MD
• Phone: 77743642523
• Email: Gianna.Wilkie[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics
• Pregnancy, High Risk

Intervention

Diagnostic Test:
• Enhanced First Trimester GDM Screening
Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
• Routine Gestational Diabetes Screening
Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Diabetes Mellitus	Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test	In pregnancy (24-28 weeks gestation)
Secondary	Mode of Delivery	Mode of delivery (Vaginal versus Cesarean delivery)	At Birth
Secondary	Neonatal Birthweight	Neonatal Birthweight	At Birth
Secondary	Number of Participants with Shoulder Dystocia	Number of Participants with Shoulder Dystocia	At Birth
Secondary	Number of participants with brachial plexus injury	Number of participants with brachial plexus injury	At Birth
Secondary	APGAR Score	APGAR Score (range 0 to 10, with 10 being the best)	At Birth
Secondary	Neonatal Intensive Care Unit Admission	Admission to Level 2 or greater neonatal ICU and length of stay	At delivery and within first 2 days of life
Secondary	Gestational Age at Delivery	Gestational Age at Delivery	At Birth
Secondary	Patient Satisfaction with Diabetes Screening Method	This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)	Postpartum day 1 after birth