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Table 3 Study procedures/study visit schedule

From: Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial

Day

0

1

2

3

7

14

21

28

35

42

49

56

63

Any other day1

Delivery

4-6 weeks post-partum

EPI clinics

1 year post-partum

History (symptoms)

X

                 

Informed consent

X

                 

Examination (clinical)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

   

Foetal viability

X

  

X

X

X

X

X

X

X

X

X

X

X

    

Blood Pressure

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

   

Temperature

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

   

Blood film

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

   

Filter paper PCR

X

   

X

X

X

X

X

X

X

X

X

X

X 2

   

Adverse events

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

   

Concomitant medications

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  

Hb

X

   

X

X

 

X

 

X

  

X

 

X

   

Haematology

X

   

X

X

 

X

    

X

 

X

   

Treatment

X

X

X

               

Blood sample for PK

    

X

             

Pop PK

3 samples/woman according to a predefined schedule (120 women in 3 sites each)

In vitro test

X

and time of recurrent infection

Biochemistry

X

   

X

X

 

X3

    

X4

     

Placenta sample

              

X

   

New born assessment

              

X

X

  

Infant assessment

                

X

X

  1. 1Spontaneous attendance to the health facility.
  2. 2Includes placental blood sample.
  3. 3Only ALAT and total bilirubin.
  4. 4Only ALAT and total bilirubin, and only if abnormal at Day 28.
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Reproductive Health

ISSN: 1742-4755