Table 5.
Maternal pregnancy complications by study arm and cohort
| Cohort 1 | Cohort 2 | Local background frequencies (95% CI) of pregnancy complications1 | |||
|---|---|---|---|---|---|
| Pregnancy complication | Dapivirine arm (n=99) n (%) | TDF/FTC arm (n=49) n (%) | Dapivirine arm (n=106) n (%) | TDF/FTC arm (n=51) n (%) | |
| Any hypertensive disorder of pregnancy2 | 3 (3) | 4 (8) | 9 (8) | 5 (10) | 10.5% (10.0,11.3) |
| Gestational hypertension | 3 (3) | 2 (4) | 6 (6) | 5 (10) | 4.4% (4.0,4.8) |
| Pre-eclampsia without severe features | 0 (0) | 1 (2) | 1 (1) | 0 (0) | 2.2% (1.9,2.5) |
| Pre-eclampsia with severe features | 0 (0) | 1 (2) | 2 (2) | 0 (0) | 2.1% (1.9,2.4) |
| Eclampsia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0.6% (0.5,0.8) |
| Peripartum/Antepartum hemorrhage | 0 (0) | 1 (2) | 2 (2) | 2 (4) | -- |
| Postpartum hemorrhage | 2 (2) | 1 (2) | 2 (2) | 0 (0) | 3.2% (2.9,3.6) |
| Fever of unclear etiology | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0.1% (0.1–0.2%) |
| Chorioamnionitis | 0 (0) | 0 (0) | 1 (1) | 0 (0) | 0.2% (0.1–0.3%) |
| Postpartum endometritis | 0 (0) | 0 (0) | 0 (0) | 1 (2) | 0.4% (0.3–0.5%) |
| Puerperal sepsis | 0 (0) | 0 (0) | 0 (0) | 2 (4) | - |
| Other3 | 1 (1) | 1 (2) | 4 (4) | 0 (0) | - |
1
Data on background rates obtained as part of a published systematic chart review (MTN-042B).28 Peripartum/Antepartum hemorrhage and Puerperal sepsis were not assessed in MTN-042B.
2
Any hypertensive disorders is the total of the gestational hypertension, pre-eclampsia without severe features, pre-eclampsia with severe features, and eclampsia rows.
3
Others included placenta previa and postpartum anemia for cohort 1 and obstructed labor, oligohydramnios, placenta previa and wound cellulitis for cohort 2
Abbreviations: TDF/FTC= tenofovir disoproxil fumarate/emtricitabine; CI = confidence interval