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

Primary Purpose

Pregnancy Complications, Gestational Diabetes Mellitus in Pregnancy

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
early screening and intervention
standard screening and intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Complications focused on measuring early screening, early intervention, gestational diabetes mellitus, pregnancy outcomes, randomized controlled trial

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Internal Medicine, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early-screen Group

Standard-screen Group

Arm Description

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). The time of early screening and intervention will be 6-8 weeks earlier than that of 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). The time of standard screening and intervention will be 6-8 weeks later than that of early screening and intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Preterm delivery
the occurrence rate of preterm delivery
Jaundice
the occurrence rate of newborns with jaundice
Admission to NICU
the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)
Fetal death or stillbirth
the occurrence rate of fetal death or stillbirth
Fetal growth during pregnancy
measurement of fetal growth during pregnancy recorded by ultrasonography
Neonatal adiposity
measurement of neonatal adiposity recorded by skinfold caliper
Maternal incident diabetes
the incidence of maternal diabetes after delivery
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

Full Information

First Posted
April 18, 2018
Last Updated
August 23, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03523143
Brief Title
The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes
Acronym
TESGO
Official Title
The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Gestational Diabetes Mellitus in Pregnancy
Keywords
early screening, early intervention, gestational diabetes mellitus, pregnancy outcomes, randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
967 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early-screen Group
Arm Type
Experimental
Arm Description
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). The time of early screening and intervention will be 6-8 weeks earlier than that of standard screening and intervention.
Arm Title
Standard-screen Group
Arm Type
Active Comparator
Arm Description
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). The time of standard screening and intervention will be 6-8 weeks later than that of early screening and intervention.
Intervention Type
Other
Intervention Name(s)
early screening and intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
standard screening and intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
TESGO composite outcome
Description
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
Time Frame
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 Outcome Measure Information:
Title
Preterm delivery
Description
the occurrence rate of preterm delivery
Time Frame
This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Title
Jaundice
Description
the occurrence rate of newborns with jaundice
Time Frame
This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Title
Admission to NICU
Description
the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)
Time Frame
This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Title
Fetal death or stillbirth
Description
the occurrence rate of fetal death or stillbirth
Time Frame
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
Title
Fetal growth during pregnancy
Description
measurement of fetal growth during pregnancy recorded by ultrasonography
Time Frame
The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Title
Neonatal adiposity
Description
measurement of neonatal adiposity recorded by skinfold caliper
Time Frame
The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Title
Maternal incident diabetes
Description
the incidence of maternal diabetes after delivery
Time Frame
This secondary outcome is measured during 3 years after delivery for eligible women
Title
The growth and development of the offspring
Description
measurement of the growth and development of the offspring, including body height, body weight, head circumference, and records of any major disease
Time Frame
This secondary outcome is measured during 3 years after delivery for eligible infants

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years old First prenatal visit before 14 weeks of GA Deliver a singleton at medical centers, including National Taiwan University Hospital (NTUH), and NTUH, Hsinchu Branch. Exclusion Criteria: Diagnosed with preexisting diabetes Twin or multiple births pregnancy Current exposure to steroids Cannot tolerate an OGTT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Yuan Li, Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20855548
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: 10.2337/dc10-0607. Epub 2010 Sep 20.
Results Reference
result
PubMed Identifier
16260212
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/j.ajog.2005.04.015.
Results Reference
result
PubMed Identifier
21622950
Citation
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/kwr067. Epub 2011 May 27.
Results Reference
result
PubMed Identifier
12069734
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. doi: 10.1016/s0301-2115(02)00048-9.
Results Reference
result
PubMed Identifier
15498523
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. 2004 Nov;37(11):968-73. doi: 10.1016/j.clinbiochem.2004.07.009.
Results Reference
result
PubMed Identifier
25078866
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.
Results Reference
result
PubMed Identifier
27208333
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.
Results Reference
result
PubMed Identifier
20150300
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.
Results Reference
result
PubMed Identifier
25414152
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 Medicine Units (MFMU) Network. Mild gestational diabetes mellitus and long-term child health. Diabetes Care. 2015 Mar;38(3):445-52. doi: 10.2337/dc14-2159. Epub 2014 Nov 20.
Results Reference
result
PubMed Identifier
18596274
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.
Results Reference
result
PubMed Identifier
24779963
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.
Results Reference
result
PubMed Identifier
17465856
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.
Results Reference
result
PubMed Identifier
23515667
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.
Results Reference
result
PubMed Identifier
20190296
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 association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
Results Reference
result
PubMed Identifier
17596481
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. Diabetes Care. 2007 Jul;30 Suppl 2:S251-60. doi: 10.2337/dc07-s225. No abstract available. Erratum In: Diabetes Care. 2007 Dec;30(12):3154.
Results Reference
result
PubMed Identifier
15855602
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 abstract available.
Results Reference
result
PubMed Identifier
23589542
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;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15.
Results Reference
result

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

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