| 9th-13th | 16th-20th | 23rd-24th | Total | |
|---|---|---|---|---|
| Provided informed consent #1 | 43 | 48 | 17 | 108 |
| Provided informed consent #2 | 7 | 20 | 7 | 34 |
| Provided informed consent #3 | 0 | 0 | 2 | 2 |
| 9th-13th | 16th-20th | 23rd-24th | Total | |
|---|---|---|---|---|
| LNG IUS | 0 | 0 | 2 | 2 |
| COC | 0 | 0 | 0 | 0 |
| Totol | 0 | 0 | 2 | 2 |
| 9th-13th | 16th-20th | 23rd-24th | Total | |
|---|---|---|---|---|
| LNG IUS | 0 | 0 | 1 | 1 |
| COC | 0 | 0 | 0 | 0 |
| Totol | 0 | 0 | 1 | 1 |
| October | November | December | Total | |
|---|---|---|---|---|
| # who provided Consent #1 | 108 | |||
| Screened out: Age | 0 | |||
| Screened out: Interest | 0 | |||
| Screened out: Hemoglobin_1 | 74 | |||
| # who provided Consent #2 | 0 | |||
| Screened out: Unwilling contact | 0 | |||
| Screened out: Phone number problem | 0 | |||
| Screened out: Unwilling appt/Hb | 0 | |||
| Screened out: Pregnant | 0 | |||
| # who provided Consent #3 | 0 | |||
| Screened out: Hemoglobin_2 | 34 | |||
| Screened out: Irregular periods | 0 | |||
| Screened out: Pregnant or postpartum | 0 | |||
| Screened out: Location | 0 | |||
| Screened out: Uninterested/Unwilling | 0 | |||
| Screened out: Exclusion criteria | 0 | |||
| Screened out: Medical contraindications | 0 | |||
| Screened out: Pelvic Exam | 0 |
| October | Total | |
|---|---|---|
| LNG IUS | 0 | |
| COC | 0 | |
| Total | 0 |
| Oct | Total | |
|---|---|---|
| LNG IUS | 0 | |
| COC | 0 | |
| Total | 0 |
| October | November | December | Total | |
|---|---|---|---|---|
| N. gonorrhea positive | ||||
| C. trachomatis positive | ||||
| hemoglobin >=127 | ||||
| hemoglobin <=86 | ||||
| Any Lab value tagged as an AE | ||||
| Serum ferritin > 500 | ||||
| Serum ferritin < 7 | ||||
| C-reactive protein > 25 | ||||
| Acid glycoprotein > 1.4 | ||||
| Soluble transferring receptor > 4.7 | ||||
| Soluble transferring receptor < 1.8 | ||||
| Mean corpuscular volume > 100 | ||||
| Mean corpuscular volume <63 |
| October | November | December | Total | |
|---|---|---|---|---|
| 3 month call | ||||
| 6 month visit | ||||
| 9 month call | ||||
| 12 month visit | ||||
| 15 month call | ||||
| 18 month visit | ||||
| unscheduled visits |
| October | November | December | Total | |
|---|---|---|---|---|
| Scheduled exit | 0 | |||
| Death | 0 | |||
| Pregnant | 0 | |||
| Withdrawl | 0 | |||
| Other | 0 |
| October | November | December | Total | |
|---|---|---|---|---|
| Screen fails | ||||
| Eligible but not enroled | ||||
| Early discontinuation | ||||
| Presently in follow up | ||||
| Completed study |
| October | November | December | Total | |
|---|---|---|---|---|
| Total number AE | 0 | |||
| Grade 1 | 0 | |||
| Grade 2 | 0 | |||
| Grade 3 | 0 | |||
| Grade 4 | 0 | |||
| Grade 5 | 0 | |||
| Total number SAE | 0 | |||
| Social ocial harm | 0 | |||
| Protocol deviation | 0 |