NCT03523143: TESGO

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

Terminated NA Last updated 18 October 2024

What this trial tests

NA trial testing early screening and intervention in Pregnancy Complications in 967 participants. Terminated before completion.

Timeline

11 June 2018

Primary endpoint
13 December 2021

26 January 2022

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	967
Start date	11 June 2018
Primary completion	13 December 2021
Estimated completion	26 January 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• early screening and intervention
• standard screening and intervention

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →
• Gestational Diabetes Mellitus in Pregnancy — all drugs for Gestational Diabetes Mellitus in Pregnancy →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 60, female only, with Pregnancy Complications or Gestational Diabetes Mellitus in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Screening for Gestational Diabetes Mellitus in Early Pregnancy: What Is the Evidence?
   Raets L, Beunen K, Benhalima K. · · 2021 · cited 34× · PMID 33803650 · DOI 10.3390/jcm10061257
2. An Update on Screening Strategies for Gestational Diabetes Mellitus: A Narrative Review.
   Minschart C, Beunen K, Benhalima K. · · 2021 · cited 15× · PMID 34262311 · DOI 10.2147/dmso.s287121
3. Early screening for gestational diabetes mellitus: a meta-analysis of randomized controlled trials.
   McLaren RA, Ruymann KR, Ramos GA, Osmundson SS, et al · · 2022 · cited 13× · PMID 36031150 · DOI 10.1016/j.ajogmf.2022.100737
4. Updates for hyperglycemia in pregnancy: The ongoing journey for maternal-neonatal health.
   Li HY, Sheu WH. · · 2022 · cited 3× · PMID 35794788 · DOI 10.1111/jdi.13881
5. The Effect of Midpregnancy Screening for Gestational Diabetes Mellitus on Pregnancy Outcomes: The TESGO Randomized Controlled Trial.
   Kuo CH, Lin MW, Chen SC, Yen IW, et al · · 2026 · cited 1× · PMID 40986699 · DOI 10.2337/dc25-0084