Study on Registry of Pregnancy with Abnormal Glucose Metabolism

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030220452

Enrollment

1320

Registered

2022-11-21

Start date

2022-10-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gestational diabetes, pregestational diabetes mellitus, overt diabetes in pregnancy

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Fluent in Japanese 2) Scheduled to deliver at Saitama Medical Center, Aiwa Hospital, Keiai Hospital, or Seto Hospital 3) Patients with gestational diabetes mellitus, pregestational diabetes mellitus, or overt diabetes mellitus in pregnancy 4) Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1) Severe history of cardiac, hepatic, or renal disease 2) Having an eating disorder 3) Research subjects the physician deems can be unsuitable for the research.

Design outcomes

Primary

Measure	Time frame
1. Pre-enrollment and Pre-treatment (1) Patient background: Age and number of weeks of pregnancy, previous childbearing experience, medical history/complications (including gestational diabetes, pre-pregnancy hypertension, and diabetes), medications, smoking history, alcohol consumption history, family history of diabetes, weight history (at age 20, maximum weight ever and age), family members living together, occupation, work style, diet, mental health, etc. (2) Pre-pregnancy weight (most recent before 12 weeks of pregnancy, self-report), height (3) Blood pressure at the time of examination (4) Hematological examination (within 14 days before registration): Hemoglobin, white blood cell count, neutrophil count, platelet count (5) Serum total bilirubin, AST, ALT, albumin, serum creatinine, HbA1c, GA, anti-GAD antibody, (fasting/as needed) serum glucose, insulin, C-peptide, high sensitivity CRP Urinalysis: Urinary protein, urinary sugar, urinary ketones, occult urinary blood (6) 75g OGTT: Blood glucose and insulin (fasting/as needed) Blood glucose, insulin (fasting/ 1 hour/ 2 hours) (7)Questionnaire survey: Time and means of hospital visits, smartphone ownership, childbirth wishes, psychological tests (Edinburgh Postnatal Depression Scale, State-Trait Anxiety Inventory) (8) Ultrasound findings: Estimated weight (BPD, HC, AC, FTA, FL), amniotic fluid volume (AFI), etc. 2. Health data submitted by the individual patient (1)Health data (PHR data) to be submitted by the individual patient: Symptoms (appetite, nausea, constipation, fatigue, etc.), pictures of meals, weight, blood glucose (2h before/after each meal), (at home) blood pressure, activity level (number of steps, sleep time, pulse) (2) (During medical examination) blood pressure, weight (3) Hematological examination: Hemoglobin, white blood cell count, neutrophil count, platelet count (4) Blood biochemical tests: Serum total bilirubin, AST, ALT, albumin, serum creatinine, HbA1c, GA, blood glucose, insulin,	—

Measure

Time frame

1. Pre-enrollment and Pre-treatment (1) Patient background: Age and number of weeks of pregnancy, previous childbearing experience, medical history/complications (including gestational diabetes, pre-pregnancy hypertension, and diabetes), medications, smoking history, alcohol consumption history, family history of diabetes, weight history (at age 20, maximum weight ever and age), family members living together, occupation, work style, diet, mental health, etc. (2) Pre-pregnancy weight (most recent before 12 weeks of pregnancy, self-report), height (3) Blood pressure at the time of examination (4) Hematological examination (within 14 days before registration): Hemoglobin, white blood cell count, neutrophil count, platelet count (5) Serum total bilirubin, AST, ALT, albumin, serum creatinine, HbA1c, GA, anti-GAD antibody, (fasting/as needed) serum glucose, insulin, C-peptide, high sensitivity CRP Urinalysis: Urinary protein, urinary sugar, urinary ketones, occult urinary blood (6) 75g OGTT: Blood glucose and insulin (fasting/as needed) Blood glucose, insulin (fasting/ 1 hour/ 2 hours) (7)Questionnaire survey: Time and means of hospital visits, smartphone ownership, childbirth wishes, psychological tests (Edinburgh Postnatal Depression Scale, State-Trait Anxiety Inventory) (8) Ultrasound findings: Estimated weight (BPD, HC, AC, FTA, FL), amniotic fluid volume (AFI), etc. 2. Health data submitted by the individual patient (1)Health data (PHR data) to be submitted by the individual patient: Symptoms (appetite, nausea, constipation, fatigue, etc.), pictures of meals, weight, blood glucose (2h before/after each meal), (at home) blood pressure, activity level (number of steps, sleep time, pulse) (2) (During medical examination) blood pressure, weight (3) Hematological examination: Hemoglobin, white blood cell count, neutrophil count, platelet count (4) Blood biochemical tests: Serum total bilirubin, AST, ALT, albumin, serum creatinine, HbA1c, GA, blood glucose, insulin,

—

Contacts

Public ContactYoko Arai

Saitama Medical University

yokoa@saitama-med.ac.jp+81-49-228-3570

Outcome results