Study on Registry of Pregnancy with Abnormal Glucose Metabolism

JRCT ID: jRCT1030220452

Registered date:21/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gestational diabetes, pregestational diabetes mellitus, overt diabetes in pregnancy
• Date of first enrollment: 28/10/2022
• Target sample size: 1320
• Study type: Observational

Outcome(s)

Primary Outcome

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, blood C-peptide, high-sensitivity CRP
Urinalysis: Urine protein, urine glucose, urine ketones, urine occult blood
(5) Questionnaire survey:
Diet, exercise, and evaluation of desire in patients for treatment, etc.
(6) Ultrasonographic findings:
Estimated weight (BPD, HC, AC, FTA, FL), amniotic fluid volume (AFI), etc.

3. Health data (at the time of delivery)
(1) Health data (PHR data) submitted by the individual patient:
(2) 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) Delivery and any complications related to the fetus
A) Items related to the fetus:
Incontinent: unintentionally overweight, gigantism (>=4000g), unintentionally underweight, low birth weight (<2500g), neonatal hypoglycemia (blood glucose <40mg/dL (2.2mmol/L) in symptomatic term infants, <45mg/dL (2.5mmol/L) in asymptomatic term infants in the first 24 to 48 hours after birth, <30mg/dL (2.5mmol/L) in early term infants within 48 hours after childbirth), less than 30 mg/dL (1.7 mmol/L) in early term infants within 48 hours of birth), neonatal hyperbilirubinemia, neonatal respiratory distress syndrome, shoulder dystocia/shoulder dystocia associated trauma during delivery, NICU admission rate, fetal death
B) Delivery-Related:
Weeks of delivery, normal vaginal delivery/suction/forceps delivery/cesarean section/emergency cesarean section, miscarriage, preterm delivery, preterm water breaking/preterm water breaking), amniotic fluid overload, prenatal steroid administration, labor induction, perineal incision, 3rd/4th-degree perineal tear
(3) Questionnaire survey:
Diet, exercise, psychological tests (Edinburgh Postnatal Depression Scale, State-Trait Anxiety Inventory), etc.

4. Postpartum
(1) Health data (PHR data) submitted by individual patients:
(2) 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 taken by Fitbit, sleep time, pulse) (at examination) blood pressure, weight
(3) Hematological tests:
Hemoglobin, white blood cell count, neutrophil count, platelet count, etc.
(4) Blood biochemical tests: Serum total bilirubin, AST, etc.
Serum total bilirubin, AST, ALT, albumin, serum creatinine, HbA1c, GA, blood glucose, insulin, blood C-peptide, high-sensitivity CRP
(5) Urinalysis.
Urine protein, urine glucose, urine ketones, urine occult blood (6) Questionnaire survey:
Diet, exercise, satisfaction with and evaluation of treatment, feedback on online medical care, costs associated with medical visits, degree of anxiety about COVID-19, etc.
(7) 75g OGTT:
Blood glucose and insulin (fasting / 1 hour / 2 hours)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Izumida Yoshihiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development