The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes

Pregnancy Complications Clinical Trial

— TESGO  

Official title:

The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03523143
• Other study ID #: 201710072RINA
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: December 13, 2023

Study information

• Verified date: August 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring. Objective: To determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group. Design, Setting, Participants: We will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at National Taiwan University Hospital (NTUH) and NTUH Hsinchu Branch from 2018 to 2020. Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-20 weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle intervention and self-monitoring of blood glucose. Pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks. Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes, including primary CS, birth weight >90th percentile, neonatal hypoglycemia, cord serum C-peptide >90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. The primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant women after randomization. Conclusion: This study will test our hypothesis that early screening and intervention of GDM improves pregnancy outcomes as compared to standard practice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 967
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age = 20 years old

2. First prenatal visit before 14 weeks of GA

3. Deliver a singleton at medical centers, including National Taiwan University Hospital (NTUH), and NTUH, Hsinchu Branch.

Exclusion Criteria:

1. Diagnosed with preexisting diabetes

2. Twin or multiple births pregnancy

3. Current exposure to steroids

4. Cannot tolerate an OGTT

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy Complications
• Pregnancy in Diabetics

Intervention

Other:
• early screening and intervention
The early screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 18-20 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the IADPSG criteria. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks. The process of screening and intervention in the early screening group is all the same with that in the standard screening group. The only difference between two groups is the time of screening and intervention (18-20 weeks vs. 24-28 weeks of GA).
• standard screening and intervention
The standard screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 24-28 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria, ie. if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, and 153 mg/dL, respectively. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks.

Locations

Country	Name	City	State
Taiwan	Department of Internal Medicine, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

Asvold BO, Eskild A, Jenum PA, Vatten LJ. Maternal concentrations of insulin-like growth factor I and insulin-like growth factor binding protein 1 during pregnancy and birth weight of offspring. Am J Epidemiol. 2011 Jul 15;174(2):129-35. doi: 10.1093/aje/ — View Citation

de Mello VD, Pulkkinen L, Lalli M, Kolehmainen M, Pihlajamaki J, Uusitupa M. DNA methylation in obesity and type 2 diabetes. Ann Med. 2014 May;46(3):103-13. doi: 10.3109/07853890.2013.857259. Epub 2014 Apr 30. — View Citation

Gillman MW, Oakey H, Baghurst PA, Volkmer RE, Robinson JS, Crowther CA. Effect of treatment of gestational diabetes mellitus on obesity in the next generation. Diabetes Care. 2010 May;33(5):964-8. doi: 10.2337/dc09-1810. Epub 2010 Feb 11. — View Citation

Gluckman PD, Hanson MA, Cooper C, Thornburg KL. Effect of in utero and early-life conditions on adult health and disease. N Engl J Med. 2008 Jul 3;359(1):61-73. doi: 10.1056/NEJMra0708473. No abstract available. — View Citation

International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International — View Citation

Landon MB, Rice MM, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Biggio JR Jr, Thorp JM, Chien EK, Saade G, Peaceman AM, Blackwell SC, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Med — View Citation

Lappas M. Insulin-like growth factor-binding protein 1 and 7 concentrations are lower in obese pregnant women, women with gestational diabetes and their fetuses. J Perinatol. 2015 Jan;35(1):32-8. doi: 10.1038/jp.2014.144. Epub 2014 Jul 31. — View Citation

Lehnen H, Zechner U, Haaf T. Epigenetics of gestational diabetes mellitus and offspring health: the time for action is in early stages of life. Mol Hum Reprod. 2013 Jul;19(7):415-22. doi: 10.1093/molehr/gat020. Epub 2013 Mar 20. — View Citation

Metzger BE, Buchanan TA, Coustan DR, de Leiva A, Dunger DB, Hadden DR, Hod M, Kitzmiller JL, Kjos SL, Oats JN, Pettitt DJ, Sacks DA, Zoupas C. Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Dia — View Citation

Ning Y, Williams MA, Vadachkoria S, Muy-Rivera M, Frederick IO, Luthy DA. Maternal plasma concentrations of insulinlike growth factor-1 and insulinlike growth factor-binding protein-1 in early pregnancy and subsequent risk of preeclampsia. Clin Biochem. 2 — View Citation

Qiu C, Vadachkoria S, Meryman L, Frederick IO, Williams MA. Maternal plasma concentrations of IGF-1, IGFBP-1, and C-peptide in early pregnancy and subsequent risk of gestational diabetes mellitus. Am J Obstet Gynecol. 2005 Nov;193(5):1691-7. doi: 10.1016/ — View Citation

Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May — View Citation

Sovio U, Murphy HR, Smith GC. Accelerated Fetal Growth Prior to Diagnosis of Gestational Diabetes Mellitus: A Prospective Cohort Study of Nulliparous Women. Diabetes Care. 2016 Jun;39(6):982-7. doi: 10.2337/dc16-0160. Epub 2016 Apr 7. — View Citation

Tisi DK, Burns DH, Luskey GW, Koski KG. Fetal exposure to altered amniotic fluid glucose, insulin, and insulin-like growth factor-binding protein 1 occurs before screening for gestational diabetes mellitus. Diabetes Care. 2011 Jan;34(1):139-44. doi: 10.23 — View Citation

Valensise H, Larciprete G, Vasapollo B, Novelli GP, Menghini S, di Pierro G, Arduini D. C-peptide and insulin levels at 24-30 weeks' gestation: an increased risk of adverse pregnancy outcomes? Eur J Obstet Gynecol Reprod Biol. 2002 Jul 10;103(2):130-5. do — View Citation

Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705. — View Citation

Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TESGO composite outcome	the occurrence rate of any of the following adverse outcome, including primary cesarean section (CS), birth weight >90th percentile, cord serum C-peptide =90th percentile, neonatal hypoglycemia, pregnancy-induced hypertension, preeclampsia, birth trauma, hypoglycemia, cord serum C-peptide >90th percentile, gestational hypertension, preeclampsia and birth trauma	The primary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months
Secondary	Preterm delivery	the occurrence rate of preterm delivery	This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Secondary	Jaundice	the occurrence rate of newborns with jaundice	This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Secondary	Admission to NICU	the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)	This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Secondary	Fetal death or stillbirth	the occurrence rate of fetal death or stillbirth	This secondary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months
Secondary	Fetal growth during pregnancy	measurement of fetal growth during pregnancy recorded by ultrasonography	The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Secondary	Neonatal adiposity	measurement of neonatal adiposity recorded by skinfold caliper	The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Secondary	Maternal incident diabetes	the incidence of maternal diabetes after delivery	This secondary outcome is measured during 3 years after delivery for eligible women
Secondary	The growth and development of the offspring	measurement of the growth and development of the offspring, including body height, body weight, head circumference, and records of any major disease	This secondary outcome is measured during 3 years after delivery for eligible infants