Background
Methods
General procedures
Non-pregnant cohort
Pregnant cohort
Laboratory procedures
Bacterial vaginosis
Vaginal eluates
Malaria microscopy
Iron status
Microbiota/T. vaginalis qPCR
Statistical analysis
Results
Participants
Variable | Pregnant cohort | Non-pregnant cohort | ||||
---|---|---|---|---|---|---|
Na
| Iron | Control | Na
| Iron | Control | |
N = 258 | N = 220 | N = 766 | N = 783 | |||
Sociodemographic | ||||||
Age, years, mean (SD) | 478 | 17.1 (1.7) | 17.1 (1.7) | 1549 | 16.7 (1.7) | 16.7 (1.8) |
Ethnic group, n (%) | ||||||
Mossi | 478 | 250 (96.9) | 214 (97.3) | 1548 | 730 (95.3) | 757 (96.8) |
Other | 478 | 8 (3.1) | 6 (2.7) | 1548 | 36 (4.7) | 25 (3.2) |
Marital status | ||||||
Married | 478 | 22 (8.5) | 15 (6.8) | 1544 | 17 (2.2) | 18 (2.3) |
Never married | 478 | 236 (91.5) | 204 (92.7) | 1544 | 748 (97.8) | 760 (97.6) |
Previously married | 478 | 0 (0) | 1 (0.5) | 1544 | 0 (0) | 1 (0.1) |
Occupation,b n (%) | ||||||
Student | 478 | 60 (23.3) | 51 (23.2) | 1549 | 255 (33.3) | 274 (35.0) |
Trading | 478 | 10 (3.9) | 10 (4.5) | 1549 | 24 (3.1) | 21 (2.7) |
Domestic labour | 478 | 154 (59.7) | 120 (54.5) | 1549 | 401 (52.3) | 407 (52.0) |
Farming | 478 | 130 (50.4) | 101 (45.9) | 1549 | 269 (35.1) | 290 (37.0) |
Other | 478 | 3 (1.2) | 3 (1.4) | 1549 | 3 (0.4) | 2 (0.3) |
Education, n (%) | ||||||
No schooling | 477 | 176 (68.5) | 142 (64.5) | 1544 | 447 (58.6) | 450 (57.6) |
Primary | 478 | 54 (20.9) | 38 (17.3) | 1549 | 168 (21.9) | 169 (21.6) |
Lower secondary | 477 | 24 (9.3) | 38 (17.3) | 1544 | 144 (18.9) | 153 (19.6) |
Higher secondary | 477 | 3 (1.2) | 2 (0.9) | 1544 | 4 (0.5) | 9 (1.2) |
Literate, n (%) | 473 | 68 (26.7) | 62 (28.4) | 1530 | 278 (36.8) | 297 (38.4) |
Reproductive history and infections, n (%) | ||||||
Menarcheal | 478 | 241 (93.4) | 203 (92.3) | 1549 | 639 (83.4) | 645 (82.4) |
Menarche age, mean (SD) | 443 | 14.9 (1.0) | 14.8 (1.1) | 1279 | 15 (1.0) | 15.1 (1.1) |
Ever had sex | 478 | 98 (38) | 82 (37.3) | 1548 | 159 (20.8) | 164 (21.0) |
Uses contraception | 478 | 54 (20.9) | 51 (23.2) | 1549 | 106 (13.8) | 86 (11.0) |
Uses condoms | 478 | 53 (20.5) | 50 (22.7) | 1549 | 103 (13.4) | 81 (10.3) |
Nugent 7–10 | 391 | 33 (15.7) | 23 (12.7) | 1247 | 80 (13.0) | 68 (10.8) |
Nugent 4–6 | 391 | 17 (8.1) | 11 (6.1) | 1247 | 49 (8.0) | 66 (10.5) |
Nugent 0–3 | 391 | 160 (76.2) | 147 (81.2) | 1247 | 487 (79.1) | 497 (78.8) |
Vaginal discharge | 478 | 3 (1.2) | 4 (1.8) | 1549 | 13 (1.7) | 12 (1.5) |
Vaginal pH ≥ 4.5 | 394 | 119 (55.9) | 84 (46.4) | 1280 | 317 (50.3) | 328 (50.5) |
Nutrition and iron biomarkers, n (%) | ||||||
Drinks alcohol | 476 | 140 (54.5) | 119 (54.3) | 1549 | 372 (48.6) | 380 (48.5) |
BMI, kg/m2, mean (SD) | 478 | 20.2 (1.8) | 20.3 (2.1) | 1549 | 19.7 (2.2) | 19.6 (2.2) |
MUAC, cm, mean (SD) | 478 | 24.1 (1.8) | 24.3 (2.2) | 1549 | 23.6 (2.1) | 23.6 (2.2) |
Iron deficient (adjFE) | 467 | 25 (10.0) | 26 (12.0) | 1528 | 84 (11.1) | 100 (13.0) |
Iron deficient (ratio sTfR/log ferritin) | 470 | 52 (20.6) | 55 (25.3) | 1524 | 162 (21.4) | 168 (21.9) |
Adherence to treatment | ||||||
DOT,c mean (SD) | 478 | 70.3 (27.0) | 71.4 (26.0) | 1549 | 70.0 (27.8) | 70.8 (26.3) |
Infections and iron status at baseline assessment
Infection | N | Replete (%) | Deficient (%) | Unadjusted | Adjusteda
| |||
---|---|---|---|---|---|---|---|---|
RR (95% CI) |
P valueb
| Nc
| RR (95% CI) |
P value | ||||
Adjusted ferritin | ||||||||
BVd
| 1347 | 0.127 | 1326 | 0.032 | ||||
Nugent 7–10e
| 1347 | 142/1151 (12.3) | 15/175 (8.6) | 1.44 (0.87–2.39) | 0.168 | 1326 | 1.53 (0.92–2.54) | 0.104 |
Nugent 4–6e
| 1347 | 108/1151 (9.4) | 11/175 (6.3) | 1.49 (0.82–2.72) | 0.203 | 1326 | 1.47 (0.81–2.68) | 0.210 |
Nugent 0–3e
| 1347 | 901/1151 (78.3) | 149/175 (85.1) | 0.92 (0.86–0.99) | 0.036 | 1326 | 0.92 (0.86–0.98) | 0.016 |
Vaginal discharge | 1673 | 21/1430 (1.5) | 8/214 (3.7) | 0.39 (0.18–0.88) | 0.044 | 1644 | 0.41 (0.18–0.92) | 0.030 |
pH ≥ 4.5 | 1371 | 608/1166 (52.1) | 86/183 (47.0) | 1.11 (0.94–1.31) | 0.204 | 1349 | 1.11 (0.94–1.30) | 0.222 |
sTfR/log ferritin ratio > 5.6 | ||||||||
BVd
| 1347 | 0.513 | 1324 | 0.224 | ||||
Nugent 7–10e
| 1347 | 127/1030 (12.3) | 30/294 (10.2) | 1.21 (0.83–1.76) | 0.358 | 1324 | 1.25 (0.86–1.83) | 0.239 |
Nugent 4–6e
| 1347 | 95/1030 (9.2) | 24/294 (8.2) | 1.13 (0.74–1.73) | 0.644 | 1324 | 1.12 (0.73–1.71) | 0.619 |
Nugent 0–3e
| 1347 | 808/1030 (78.4) | 240/294 (81.6) | 0.96 (0.90–1.02) | 0.255 | 1324 | 0.96 (0.90–1.02) | 0.231 |
Vaginal discharge | 1673 | 18/1270 (1.4) | 11/372 (3.0) | 0.48 (0.23–1.01) | 0.070 | 1642 | 0.49 (0.23–1.04) | 0.062 |
pH ≥ 4.5 | 1371 | 551/1044 (52.8) | 144/303 (47.5) | 1.11 (0.97–1.27) | 0.117 | 1347 | 1.11 (0.97–1.26) | 0.126 |
Lower genital tract infection in the pregnant cohort
ANC1
Assessment | Infection marker | N | Trial arm | Unadjusted | Adjusteda
| ||||
---|---|---|---|---|---|---|---|---|---|
Iron (%) | Control (%) | RR (95% CI) |
P valueb
| Nc
| RR (95% CI) |
P valuec
| |||
Pregnant | Bacterial vaginosisd
| 298 | 0.776 | 245 | 0.704 | ||||
ANC1 | Nugent 7–10e
| 298 | 12/152 (7.9) | 9/146 (6.2) | 1.28 (0.56–2.95) | 0.653 | 245 | 0.93 (0.33–2.56) | 0.881 |
N = 315 | Nugent 4–6e
| 298 | 17/152 (11.2) | 19/146 (13.0) | 0.86 (0.47–1.59) | 0.723 | 245 | 0.94 (0.47–1.88) | 0.858 |
Nugent 0–3e
| 298 | 123/152 (80.9) | 118/146 (80.8) | 1.00 (0.90–1.12) | 1 | 245 | 1.03 (0.91–1.15) | 0.665 | |
T. vaginalis
f
| 286 | 23/147 (15.6) | 14/139 (10.1) | 1.55 (0.83–2.90) | 0.217 | 286 | 1.55 (0.83–2.90) | 0.168 | |
Vaginal discharge | 315 | 14/163 (8.6) | 12/152 (7.9) | 1.09 (0.52–2.28) | 0.841 | 315 | 1.08 (0.51–2.25) | 0.846 | |
pH ≥ 4.5 | 309 | 92/158 (58.2) | 86/151 (57.0) | 1.02 (0.84–1.24) | 0.908 | 260 | 1.06 (0.86–1.31) | 0.555 | |
Non-pregnant | Bacterial vaginosisd
| 671 | 0.588 | 546 | 0.676 | ||||
FINf
| Nugent 7–10e
| 671 | 46/341 (13.5) | 40/330 (12.1) | 1.11 (0.75–1.65) | 0.645 | 546 | 0.86 (0.56–1.34) | 0.509 |
N = 877 | Nugent 4–6e
| 671 | 35/341 (10.3) | 26/330 (7.9) | 1.30 (0.80–2.11) | 0.347 | 546 | 1.21 (0.72–2.03) | 0.467 |
Nugent 0–3e
| 671 | 260/341 (76.2) | 264/330 (80.0) | 0.95 (0.88–1.03) | 0.263 | 546 | 0.99 (0.90–1.08) | 0.806 | |
T. vaginalis
f
| 716 | 20/360 (5.6) | 15/356 (4.2) | 1.32 (0.69–2.53) | 0.489 | 716 | 1.30 (0.67–2.50) | 0.432 | |
Vaginal discharge | 874 | 49/425 (11.5) | 31/449 (6.9) | 1.67 (1.09–2.57) | 0.019 | 874 | 1.63 (1.06–2.51) | 0.026 |
Lower genital tract infection in the non-pregnant cohort
FIN
Comparison of non-pregnant and pregnant cohorts
Antibiotic courses
Treatment | Number of treatments | Mean treatments per person | Mean treatments per 50 visitsa
| Incidence ratiob (95% CI) |
P value | |||
---|---|---|---|---|---|---|---|---|
Iron | Control | Iron | Control | Iron | Control | |||
Pregnant | n = 163 | n = 152 | Visits = 6907 | Visits = 6235 | ||||
Antibiotics | 92 | 73 | 0.564 | 0.480 | 0.666 | 0.585 | 1.14 (0.84–1.55) | 0.411 |
Anti-fungalsc
| 16 | 15 | 0.098 | 0.099 | 0.116 | 0.120 | 0.96 (0.47–1.95) | 0.916 |
Analgesics | 107 | 107 | 0.656 | 0.704 | 0.775 | 0.858 | 0.90 (0.69–1.18) | 0.454 |
Non-pregnant | n = 426 | n = 451 | Visits =26473 | Visits =27633 | ||||
Antibiotics | 331 | 284 | 0.777 | 0.630 | 0.625 | 0.514 | 1.22 (1.04–1.43) | 0.015 |
Anti-fungalsc
| 39 | 21 | 0.092 | 0.047 | 0.074 | 0.038 | 1.94 (1.14–3.30) | 0.014 |
Analgesics | 481 | 421 | 1.129 | 0.933 | 0.908 | 0.762 | 1.19 (1.05–1.36) | 0.008 |
Infection indication | Iron | Control | Iron per 50 visits n = 26,473 | Control per 50 visits n = 27,633 | Incidence ratioa
(95% CI) |
P value | PFDRb
|
---|---|---|---|---|---|---|---|
Malariac
| 41 | 28 | 0.077 | 0.051 | 1.53 (0.94–2.47) | 0.084 | 0.278 |
Respiratory | 75 | 87 | 0.142 | 0.157 | 0.90 (0.66–1.23) | 0.503 | 0.719 |
Locald
| 75 | 57 | 0.142 | 0.103 | 1.37 (0.97–1.94) | 0.071 | 0.278 |
Gastrointestinale
| 62 | 30 | 0.117 | 0.054 | 2.16 (1.39–3.34) | <0.001 | 0.005 |
Urinary tractf
| 10 | 9 | 0.019 | 0.016 | 1.16 (0.47–2.86) | 0.747 | 0.934 |
STIg
| 13 | 7 | 0.025 | 0.013 | 1.94 (0.77–4.86) | 0.158 | 0.292 |
Genitalh
| 15 | 16 | 0.028 | 0.029 | 0.98 (0.48–1.98) | 0.952 | 0.993 |
Dental | 11 | 5 | 0.021 | 0.009 | 2.30 (0.80–6.62) | 0.123 | 0.292 |
Meningitis | 0 | 3 | 0 | 0.005 | 0 (NA) | 0.993 | 0.993 |
Miscellaneousi
| 29 | 42 | 0.055 | 0.076 | 0.72 (0.45–1.16) | 0.175 | 0.292 |
Vaginal microbiota
Variable | Visit | Group | n | CST I n (%) | CST III n (%) | CST IV n (%) |
P valuea
|
---|---|---|---|---|---|---|---|
Trial arm | ANC1 | Iron | 144 | 70 (48.6) | 39 (27.1) | 35 (24.3) | 0.518 |
Control | 136 | 61 (44.9) | 45 (33.1) | 30 (22.1) | |||
FINb
| Iron | 349 | 121 (34.7) | 88 (25.2) | 140 (40.1) | 0.113 | |
Control | 341 | 140 (1.1) | 66 (19.4) | 135 (9.6) | |||
Iron deficiency, Adjusted ferritin | ANC1 | No | 249 | 118 (47.4) | 75 (30.1) | 56 (22.5) | 0.57 |
Yes | 27 | 10 (37.0) | 9 (33.3) | 8 (29.6) | |||
FINb
| No | 620 | 237 (38.2) | 140 (22.6) | 243 (39.2) | 0.281 | |
Yes | 65 | 20 (30.8) | 13 (20.0) | 32 (49.2) | |||
Ratio sTfR/log ferritin | ANC1 | No | 247 | 120 (48.6) | 74 (30.0) | 53 (21.5) | 0.216 |
Yes | 32 | 11 (34.4) | 10 (31.2) | 11 (34.4) | |||
FINb
| No | 544 | 205 (37.7) | 124 (22.8) | 215 (39.5) | 0.81 | |
Yes | 140 | 52 (37.1) | 29 (20.7) | 59 (42.1) | |||
Nugent scorec
| ANC1 | 7-10 | 15 | 0 (0) | 1 (6.7) | 14 (93.3) | <0.001 |
4-6 | 31 | 7 (22.6) | 6 (19.4) | 18 (58.1) | <0.001 | ||
0-3 | 221 | 116 (52.5) | 74 (33.5) | 31 (14.0) | <0.001 | ||
FINb
| 7-10 | 80 | 2 (2.5) | 6 (7.5) | 72 (90.0) | <0.001 | |
4-6 | 60 | 11 (18.3) | 6 (10.0) | 43 (71.7) | <0.001 | ||
0-3 | 501 | 232 (46.3) | 132 (26.3) | 137 (27.3) | <0.001 | ||
T. vaginalis
| ANC1 | No | 243 | 121 (49.8) | 73 (30.0) | 49 (20.2) | 0.006 |
Yes | 37 | 10 (27.0) | 11 (29.7) | 16 (43.2) | |||
FINb
| No | 655 | 260 (39.7) | 149 (22.7) | 246 (37.6) | <0.001 | |
Yes | 35 | 1 (2.9) | 5 (14.3) | 29 (82.9) | |||
High pH ≥ 4.5 | ANC1 | No | 123 | 73 (59.3) | 37 (30.1) | 13 (10.6) | <0.001 |
Yes | 153 | 58 (37.9) | 45 (29.4) | 50 (32.7) | |||
Vaginal discharge | ANC1 | No | 260 | 122 (46.9) | 80 (30.8) | 58 (22.3) | 0.268 |
Yes | 20 | 9 (4.5) | 4 (20.0) | 7 (35.0) | |||
FINb
| No | 618 | 232 (37.5) | 144 (23.3) | 242 (39.2) | 0.205 | |
Yes | 69 | 28 (40.6) | 10 (14.5) | 31 (44.9) | |||
Antibiotics within previous three months | ANC1 | No | 252 | 118 (46.8) | 73 (29.0) | 61 (24.2) | NA |
Yes | 28 | 13 (46.4) | 11 (39.3) | 4 (14.3) | |||
FINb
| No | 616 | 236 (38.3) | 136 (22.1) | 244 (39.6) | NA | |
Yes | 74 | 25 (33.8) | 18 (24.3) | 31 (41.9) |