Study procedures and timing of the molecular signature in pregnancy cohort13
Screening | Baseline | Follow-up | Unwell episode | Birth | Post partum | |
Viable singletons pregnancy | X | |||||
Obstetric ultrasound* | X | X | X | |||
Eligibility assessment | X | |||||
Written informed consent | X | |||||
Demographics | X | |||||
Medical and obstetric history | X | |||||
Concomitant medications | X | X | X | X | X | |
Physical examination | X | X | X | X | X | |
Universal pregnancy screening, for example, thick and thin blood film for malaria diagnosis, CBC and OGTT† | X | (X)† | ||||
Sample maternal 100 µL capillary blood‡ | X | X§ | X¶ | X** | X†† | |
Sample vaginal swab, stool specimen and 24 hours food recall | X‡‡ | X‡‡ | X | X | X§§ | |
Acceptability survey | X | X | ||||
Sample saliva | X¶¶ | X | ||||
Sample placenta, cord blood and maternal venous blood | X |
*Fetal growth scans on a 6-weekly basis.
†OGTT at 24–26 weeks of gestation; repeated at 12 weeks post partum if positive during pregnancy.
‡50 µL for whole blood transcriptome analysis and 50 µL for haematocrit.
§2-weekly; if the woman attended all expected 15 visits total blood is 1.5 mL.
¶If the woman attended for an unwell visit, an additional 100 µL of blood were drawn.
**If delivery at SMRU clinic, then an additional 100 µL of blood were drawn.
††At 1, 2 and 3 months postpartum, including maternal haematocrit.
‡‡In each trimester of pregnancy: 8–14, 20–22 and 34–35 weeks.
§§Vaginal swab samples at 4–6 weeks and at 3 months.
¶¶At 24–26 weeks of gestation.
CBC, complete blood count; OGTT, oral glucose tolerance test; SMRU, Shoklo Malaria Research Unit.