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

National Taiwan University

Status: Active, not recruiting

Conditions: Gestational Diabetes Mellitus in Pregnancy; Pregnancy Complications

Treatments: Other: early screening and intervention; Other: standard screening and intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03523143

201710072RINA

Details and patient eligibility

About

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.

Enrollment: 967 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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967 participants in 2 patient groups

Early-screen Group

Experimental group

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.

Treatment:

Other: early screening and intervention

Standard-screen Group

Active Comparator group

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.

Treatment:

Other: standard screening and intervention