Clinical trial NCT03523143: The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes
Official title: The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Complications
Gestational Diabetes Mellitus in Pregnancy
Keywords: early screening
early intervention
gestational diabetes mellitus
pregnancy outcomes
randomized controlled trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 967
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: TESGO composite outcome
timeFrame: 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 outcomes:
measure: Preterm delivery
timeFrame: This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
measure: Jaundice
timeFrame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
measure: Admission to NICU
timeFrame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
measure: Fetal death or stillbirth
timeFrame: 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
measure: Fetal growth during pregnancy
timeFrame: The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
measure: Neonatal adiposity
timeFrame: The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
measure: Maternal incident diabetes
timeFrame: This secondary outcome is measured during 3 years after delivery for eligible women
measure: The growth and development of the offspring
timeFrame: This secondary outcome is measured during 3 years after delivery for eligible infants
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Internal Medicine, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hung-Yuan Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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