Examples of trials of IV iron formulations and dosing in pregnancy
| Reference/ study ID . | Design . | Iron formulation . | Participants . | Dosing . |
|---|---|---|---|---|
| Iron sucrose | ||||
| 47 | RCT | IS vs oral | 271 anemic women, 148 late pregnancy | 400 mg of IS divided into two 200-mg infusions of 30-min duration, given a minimum of 24 h apart |
| 48 | RCT | IS vs oral | 100 pregnant patients, weeks 24-34 | IS divided doses of 200 mg on alternate days |
| 113 | RCT | IS vs IM iron sorbitol citric acid | 60 pregnant, weeks 12-32 | IS 200 mg, over 30 min, each infusion (to a total according to a formula of total iron deficit) |
| 49 | RCT | IS vs oral | 89 pregnant patients, weeks 14-36 | IS 200 mg each infusion (to a total according to a formula of total iron deficit) |
| 70 | Retrospective observational comparative | IS vs FCM | 206 pregnant women after 13 wk | IS 400 mg iron per week in 2 infusions, 48 h apart, FCM most patients 1000 mg |
| 50 | RCT | IS vs oral | 260 pregnant, weeks 21-37 | IS 200 mg, either a total of 2 doses (first week 21-24, second week 28-32) or 3 doses (third week 35-37) |
| 51 | RCT | IS vs oral | 106 women in third trimester | IS in each infusion, the maximum total dose administered was 200 mg infused in 20-30 min, total dose was administered over 5 d and maximum daily dose administered was 400, usually every other day |
| 52 | RCT | IS vs oral | Week 24-28 | IS administered according to a formula* |
| LMWID | ||||
| 66 | Retrospective observational study | LMWID | 189 s and third-trimester pregnant women | Single infusion of 1000 mg, 1 h |
| 67 | Nonrandomized prospective trial | LMWID | 100 pregnant women after 12 wk | Single infusion, amount given according to calculated iron deficit |
| FCM | ||||
| 53 (FER-ASAP) | RCT | FCM vs oral iron (ferrous sulfate) | 252 pregnant women their second or third trimester (gestational weeks 16-33) | 1000-1500 mg, according to weight and Hb level: Weight <66 kg, Hb 8-9: 3 × 500 mg iron within 2 wk of baseline; Weight <66 kg, Hb 9-10.5/11: 2 × 500 mg iron within 2 wk of baseline; Weight >66 kg, Hb 8-9: 1 × 1000 mg iron, followed by 1×500 mg iron 1 wk later; Weight >66 kg, Hb 9-10.5/11: 1 × 1000 mg iron |
| 69 | Prospective observational | FCM | 65 pregnant, second and third trimester | FCM 15 mg/kg |
| 114 | Retrospective observational | FCM | 64 pregnant women | FCM 1000 mg in a single infusion of 15 min weekly. Most received only 1 dose. |
| 68† | Retrospective observational comparative | FCM vs LMWID | 92 pregnant women | FCM in doses of up to a maximum of 1000 mg. LMWID maximum of 1000 mg |
| 115 | Open-label pilot study | FCM | 19 women in the third trimester of pregnancy with restless legs syndrome | 500 or 700 mg of FCM was administered over 20 min |
| Reference/ study ID . | Design . | Iron formulation . | Participants . | Dosing . |
|---|---|---|---|---|
| Iron sucrose | ||||
| 47 | RCT | IS vs oral | 271 anemic women, 148 late pregnancy | 400 mg of IS divided into two 200-mg infusions of 30-min duration, given a minimum of 24 h apart |
| 48 | RCT | IS vs oral | 100 pregnant patients, weeks 24-34 | IS divided doses of 200 mg on alternate days |
| 113 | RCT | IS vs IM iron sorbitol citric acid | 60 pregnant, weeks 12-32 | IS 200 mg, over 30 min, each infusion (to a total according to a formula of total iron deficit) |
| 49 | RCT | IS vs oral | 89 pregnant patients, weeks 14-36 | IS 200 mg each infusion (to a total according to a formula of total iron deficit) |
| 70 | Retrospective observational comparative | IS vs FCM | 206 pregnant women after 13 wk | IS 400 mg iron per week in 2 infusions, 48 h apart, FCM most patients 1000 mg |
| 50 | RCT | IS vs oral | 260 pregnant, weeks 21-37 | IS 200 mg, either a total of 2 doses (first week 21-24, second week 28-32) or 3 doses (third week 35-37) |
| 51 | RCT | IS vs oral | 106 women in third trimester | IS in each infusion, the maximum total dose administered was 200 mg infused in 20-30 min, total dose was administered over 5 d and maximum daily dose administered was 400, usually every other day |
| 52 | RCT | IS vs oral | Week 24-28 | IS administered according to a formula* |
| LMWID | ||||
| 66 | Retrospective observational study | LMWID | 189 s and third-trimester pregnant women | Single infusion of 1000 mg, 1 h |
| 67 | Nonrandomized prospective trial | LMWID | 100 pregnant women after 12 wk | Single infusion, amount given according to calculated iron deficit |
| FCM | ||||
| 53 (FER-ASAP) | RCT | FCM vs oral iron (ferrous sulfate) | 252 pregnant women their second or third trimester (gestational weeks 16-33) | 1000-1500 mg, according to weight and Hb level: Weight <66 kg, Hb 8-9: 3 × 500 mg iron within 2 wk of baseline; Weight <66 kg, Hb 9-10.5/11: 2 × 500 mg iron within 2 wk of baseline; Weight >66 kg, Hb 8-9: 1 × 1000 mg iron, followed by 1×500 mg iron 1 wk later; Weight >66 kg, Hb 9-10.5/11: 1 × 1000 mg iron |
| 69 | Prospective observational | FCM | 65 pregnant, second and third trimester | FCM 15 mg/kg |
| 114 | Retrospective observational | FCM | 64 pregnant women | FCM 1000 mg in a single infusion of 15 min weekly. Most received only 1 dose. |
| 68† | Retrospective observational comparative | FCM vs LMWID | 92 pregnant women | FCM in doses of up to a maximum of 1000 mg. LMWID maximum of 1000 mg |
| 115 | Open-label pilot study | FCM | 19 women in the third trimester of pregnancy with restless legs syndrome | 500 or 700 mg of FCM was administered over 20 min |