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Trial record 2 of 3 for:    18596274 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03523143
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Pregnancy Complications Gestational Diabetes Mellitus in Pregnancy Other: early screening and intervention Other: standard screening and intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2068 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early-screen Group
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.
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).

Active Comparator: Standard-screen Group
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.
Other: 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.




Primary Outcome Measures :
  1. TESGO composite outcome [ 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 ]
    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 :
  1. 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 ]
    the occurrence rate of preterm delivery

  2. Jaundice [ Time Frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks ]
    the occurrence rate of newborns with jaundice

  3. Admission to NICU [ Time Frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks ]
    the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)

  4. 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 ]
    the occurrence rate of fetal death or stillbirth

  5. Fetal growth during pregnancy [ Time Frame: The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months ]
    measurement of fetal growth during pregnancy recorded by ultrasonography

  6. Neonatal adiposity [ Time Frame: The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks ]
    measurement of neonatal adiposity recorded by skinfold caliper

  7. Maternal incident diabetes [ Time Frame: This secondary outcome is measured during 3 years after delivery for eligible women ]
    the incidence of maternal diabetes after delivery

  8. The growth and development of the offspring [ Time Frame: This secondary outcome is measured during 3 years after delivery for eligible infants ]
    measurement of the growth and development of the offspring, including body height, body weight, head circumference, and records of any major disease



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523143


Contacts
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Contact: Hung-Yuan Li, Ph.D. 02-23123456 ext 63540 larsli@ntuh.gov.tw

Locations
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Taiwan
Department of Internal Medicine, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sub-Investigator: Chun-Heng Kuo, MSc         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Hung-Yuan Li, Ph.D. National Taiwan University Hospital

Publications of Results:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03523143     History of Changes
Other Study ID Numbers: 201710072RINA
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by National Taiwan University Hospital:
early screening
early intervention
gestational diabetes mellitus
pregnancy outcomes
randomized controlled trial

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Pregnancy Complications
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases