Pregnancy ComplicationsTESGONCT03523143
The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes
A study testing early screening and intervention and standard screening and intervention in people with Pregnancy Complications and Gestational Diabetes Mellitus in Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- early screening and intervention and standard screening and intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2018to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with preexisting diabetes
- Twin or multiple births pregnancy
- Current exposure to steroids
- Cannot tolerate an OGTT
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
About this study
Official title: The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
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.
Read more
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.
- Being tested
- early screening and intervention, standard screening and intervention
- Keywords
- early screening, early intervention, gestational diabetes mellitus, pregnancy outcomes, randomized controlled trial
- Medical subject headings
- Pregnancy Complications, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early screening and interventionOther
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).
standard screening and interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early-screen Group | Experimental | 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. Receives: Other: early screening and intervention |
| Standard-screen Group | Active comparator | 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. Receives: Other: standard screening and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (8)
Preterm delivery
the occurrence rate of preterm delivery
Measured: This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Jaundice
the occurrence rate of newborns with jaundice
Measured: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Admission to NICU
the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)
Measured: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Fetal death or stillbirth
the occurrence rate of fetal death or stillbirth
Measured: 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
Fetal growth during pregnancy
measurement of fetal growth during pregnancy recorded by ultrasonography
Measured: The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Neonatal adiposity
measurement of neonatal adiposity recorded by skinfold caliper
Measured: The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Maternal incident diabetes
the incidence of maternal diabetes after delivery
Measured: This secondary outcome is measured during 3 years after delivery for eligible women
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
Measured: This secondary outcome is measured during 3 years after delivery for eligible infants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start11 Jun 2018
- Primary completion13 Dec 2021
- Study completion26 Jan 2022
Why it stopped: At the interim analysis, the effect observed in this study was in the opposite direction in comparison to the original hypothesis. The three external experts decided that the trial should be stopped early according to pre-specified adaptation plans.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Yuan Li, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523143
- Sponsor's protocol ID
- 201710072RINA
- Acronym
- TESGO
- Status last verified
- Oct 2024
- First submitted
- 18 Apr 2018
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20855548Qiu 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.
PubMed 16260212Asvold 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.
PubMed 21622950Valensise 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.
PubMed 12069734Ning 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.
PubMed 15498523Lappas 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.
PubMed 25078866Sovio 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.
PubMed 27208333Gillman 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.
PubMed 20150300Landon 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.
PubMed 25414152Gluckman 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.
PubMed 18596274de 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.
PubMed 24779963Waterland 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.
PubMed 17465856Lehnen 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.
PubMed 23515667International 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.
PubMed 20190296Metzger 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.
PubMed 17596481
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
- ClinicalTrials.gov ID
- NCT03523143
- Acronym / sponsor ID
- TESGO / 201710072RINA
- Keywords
- early screening, early intervention, gestational diabetes mellitus, pregnancy outcomes, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the interim analysis, the effect observed in this study was in the opposite direction in comparison to the original hypothesis. The three external experts decided that the trial should be stopped early according to pre-specified adaptation plans.
- Enrolment
- 967 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-screen Group | Experimental | Other: early screening and interventionThe 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. |
| Standard-screen Group | Active comparator | Other: standard screening and interventionThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Diagnosed with preexisting diabetes
- Twin or multiple births pregnancy
- Current exposure to steroids
- Cannot tolerate an OGTT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early screening and interventionThe 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). | Other | Early-screen Group |
| standard screening and interventionThe 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. | Other | Standard-screen Group |
Primary outcome
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
8 secondary outcomes
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
Jaundice
Time frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
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
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
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
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
Maternal incident diabetes
Time frame: This secondary outcome is measured during 3 years after delivery for eligible women
The growth and development of the offspring
Time frame: This secondary outcome is measured during 3 years after delivery for eligible infants
Results and safety
The study was stopped early (reason given: At the interim analysis, the effect observed in this study was in the opposite direction in comparison to the original hypothesis. The three external experts decided that the trial should be stopped early according to pre-specified adaptation plans.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 20855548Tisi 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.
- Background: PubMed 16260212Qiu 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.
- Background: PubMed 21622950Asvold 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.
- Background: PubMed 12069734Valensise 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.
- Background: PubMed 15498523Ning 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.
- Background: PubMed 25078866Lappas 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.
- Background: PubMed 27208333Sovio 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.
- Background: PubMed 20150300Gillman 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.
- Background: PubMed 25414152Landon 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.
- Background: PubMed 18596274Gluckman 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.
- Background: PubMed 24779963de 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.
- Background: PubMed 17465856Waterland 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Yuan Li, Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early screening and intervention and standard screening and intervention in people with Pregnancy Complications and Gestational Diabetes Mellitus in Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: At the interim analysis, the effect observed in this study was in the opposite direction in comparison to the original hypothesis. The three external experts decided that the trial should be stopped early according to pre-specified adaptation plans.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523143, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.