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Table 4 Schedule of assessments and forms

From: Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study

Study Encounter Name Screening/ Enrollment Visit(s) 7-day Contacta 14-day Contacta 21-day Contact a 28, 35, 42-day Contact a Prenatal Study Visits b Delivery Visit 30-day Postnatal Contact
Screening, informed consent, inclusion, exclusion, medical history, randomize X        
Dispense study agent X      XXX   
Dose escalation from 500 mg BID to 1000 mg BID   Xa Xa      
Collect study bottle, pill count of returned bottle       XXX X or plan to obtain  
Record total daily insulin dosing (from enrollment through delivery) X X X X X XXX X  
Maternal side effects, symptoms, episodes of hypoglycemia, adverse events   X X X X XXX X  
Maternal serious adverse events   X X X X XXX X X
Copy of glucose log       XXX X or plan to obtain  
Maternal weight and blood pressure X      XXX   
Blood draw       24–30 weeks’ gestation   
Maternal breastfeeding intention questionnaire       24–30 weeks’ gestation   
Measure infant anthropometrics        Within 72 h of delivery  
Collection of delivery and neonatal outcomes        X X
Neonatal adverse events and serious adverse events        X X
Maternal breastfeeding questionnaire postpartum         X
  1. a Dose is to be escalated at Day 7 and no later than Day 21 per subject’s study agent tolerance. Day 28, Day 35 and Day 42 contacts to occur only If indicated per subject’s study agent tolerance. All study agent tolerance contacts can be via telephone or in-person (such as during regularly scheduled pre-natal visits)
  2. b Study visits are to occur every 4 weeks during selected regularly scheduled pre-natal visits. Timing of study visits may vary based on the patient’s pre-natal visit schedule, but study visits must occur at least once each 30 days