NCT01833559

Brief Summary

The study is to investigate the impact of blood glucose management at the first trimester of pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

8.9 years

First QC Date

April 10, 2013

Last Update Submit

March 16, 2014

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • The incidence of GDM at the second gestational trimester

    The results of oral glucose tolerance test(OGTT) at the second gestational trimester(about 24-28 gestational weeks) which is used to diagnose GDM will be recorded to analysis the incidence of GDM at the second gestational trimester.

    at the second gestational trimester(about 24-28 gestational weeks)

Secondary Outcomes (1)

  • Gestational outcomes

    After delivery

Other Outcomes (2)

  • The incidence of temporal and distant metabolic disorder of mother

    2 months to 1 year after delivery

  • Child growth measures

    2 months to 1 year after delivery

Study Arms (3)

Incidence of GDM

OTHER

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Dietary Supplement: Dietary controlDrug: Insulin

Gestational outcomes

OTHER

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Dietary Supplement: Dietary controlDrug: Insulin

Metabolic disorder

OTHER

Dietary control will be suggested to patients if their fasting blood glucose is between 5.1 mmol/L and 7.0 mmol/L. If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized.

Dietary Supplement: Dietary controlDrug: Insulin

Interventions

Dietary controlDIETARY_SUPPLEMENT
Gestational outcomesIncidence of GDMMetabolic disorder
InsulinDRUG

If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.

Also known as: Novolin R, Novolin N, Novolin 30R, Novolin 50R
Gestational outcomesIncidence of GDMMetabolic disorder

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • regular antenatal examination from the first trimester;
  • accurate left mentoposterior(LMP) verified by ultrasonography(USG);
  • fasting blood glucose level between 5.1 mmol/L and 7.0 mmol/L.

You may not qualify if:

  • younger than 18 years old;
  • do not give birth in the research centers above;
  • LMP is undefined and lack of USG during 6-14 gestational weeks;
  • multiple pregnancy;
  • non-natural pregnancy(including intrauterine insemination(IUI), in-vitro fertilization and embryo transfer(IVF-ET), etc);
  • diagnosed DM before pregnancy;
  • with hepatitis B virus, hepatitis C virus, HIV infection;
  • taking drugs including glucocorticoid, diuretic, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker(ACEI/ARB), etc.
  • complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecology and obstetrics department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

InsulinIsophane Insulin, Human

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, IsophaneInsulin, Long-ActingInsulin, Regular, Human

Central Study Contacts

Zilian Wang, Doctor

CONTACT

13602885248zilianwang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 17, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2021

Study Completion

August 1, 2021

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

CN(1)