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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