Secondary outcomes
| . | Enoxaparin . | Placebo . | P . |
|---|---|---|---|
| Adverse events | |||
| N | 138 | 118 | |
| Congenital abnormality*, n (%) | 7 (5) | 3 (2.5) | .35 |
| Major bleeding, n (%) | 2 (1.4) | 2 (1.7) | 1 |
| Blood transfusion†, n | 2 | 0 | |
| Fall in hemoglobin level ≥20g/L, n | 2 | 2 | |
| Minor bleeding, n (%) | 33 (23.9) | 17 (14.4) | .06 |
| Bruising, n (%) | 11 (7.9) | 4 (3.4) | .18 |
| Nosebleed, n (%) | 10 (7.2) | 5 (4.2) | .3 |
| Bleeding gums, n (%) | 3 (2.2) | 2 (1.7) | 1 |
| Minor vaginal bleeding, n (%) | 9 (6.5) | 6 (5) | .63 |
| Severe skin reaction at the injection site, n (%) | 1 (0.7) | 0 (0) | 1 |
| Thrombocytopenia‡, n (%) | 4 (2.9) | 3 (2.5) | 1 |
| Pregnancy outcomes before 20 weeks | |||
| N | 138 | 118 | |
| Miscarriage, n (%) | 42 (30.4) | 28 (23.7) | .26 |
| Miscarriage ≥ 10 wk, n | 7 | 4 | |
| Gestational age at miscarriage, wk (mean [SD]) | 8.2 (1.97) | 8.5 (2.8) | .6 |
| Medically indicated termination of pregnancy§, n (%) | 2 (1.4) | 1 (0.8) | 1 |
| Ectopic pregnancy, n (%) | 2 (1.4) | 1 (0.8) | 1 |
| Outcomes of ongoing pregnancies after 20 weeks | |||
| N | 92 | 88 | |
| Intrauterine fetal death, n (%) | 0 (0) | 1 (1.1) | 1 |
| Medically-indicated termination of pregnancy§, n (%) | 0 (0) | 1 (1.1) | 1 |
| Preeclampsia, n (%) | 6 (6.5) | 2 (2.3) | .28 |
| Placental abruption, n (%) | 0 (0) | 0 (0) | 1 |
| Small for gestational age (<10th percentile), n (%) | 1 (1) | 3 (3.4) | .36 |
| Premature delivery, n (%) | 7 (7.6) | 7 (7.9) | 1 |
| ≥24 to <28 weeks, n | 1 | 0 | |
| ≥28 to < 32 weeks, n | 0 | 2 | |
| ≥32 to < 37 weeks, n | 6 | 5 | |
| Multiple gestation, n (%) | 1 (1) | 0 (0) | 1 |
| Outcomes of pregnancies with live birth | |||
| N | 92 | 86 | |
| Birth weight‖, g (mean [SD]) | 3283 (554) | 3142 (537) | .09 |
| Gestation time at delivery, weeks (mean [SD]) | 39.3 (2.2) | 38.9 (2.3) | .24 |
| . | Enoxaparin . | Placebo . | P . |
|---|---|---|---|
| Adverse events | |||
| N | 138 | 118 | |
| Congenital abnormality*, n (%) | 7 (5) | 3 (2.5) | .35 |
| Major bleeding, n (%) | 2 (1.4) | 2 (1.7) | 1 |
| Blood transfusion†, n | 2 | 0 | |
| Fall in hemoglobin level ≥20g/L, n | 2 | 2 | |
| Minor bleeding, n (%) | 33 (23.9) | 17 (14.4) | .06 |
| Bruising, n (%) | 11 (7.9) | 4 (3.4) | .18 |
| Nosebleed, n (%) | 10 (7.2) | 5 (4.2) | .3 |
| Bleeding gums, n (%) | 3 (2.2) | 2 (1.7) | 1 |
| Minor vaginal bleeding, n (%) | 9 (6.5) | 6 (5) | .63 |
| Severe skin reaction at the injection site, n (%) | 1 (0.7) | 0 (0) | 1 |
| Thrombocytopenia‡, n (%) | 4 (2.9) | 3 (2.5) | 1 |
| Pregnancy outcomes before 20 weeks | |||
| N | 138 | 118 | |
| Miscarriage, n (%) | 42 (30.4) | 28 (23.7) | .26 |
| Miscarriage ≥ 10 wk, n | 7 | 4 | |
| Gestational age at miscarriage, wk (mean [SD]) | 8.2 (1.97) | 8.5 (2.8) | .6 |
| Medically indicated termination of pregnancy§, n (%) | 2 (1.4) | 1 (0.8) | 1 |
| Ectopic pregnancy, n (%) | 2 (1.4) | 1 (0.8) | 1 |
| Outcomes of ongoing pregnancies after 20 weeks | |||
| N | 92 | 88 | |
| Intrauterine fetal death, n (%) | 0 (0) | 1 (1.1) | 1 |
| Medically-indicated termination of pregnancy§, n (%) | 0 (0) | 1 (1.1) | 1 |
| Preeclampsia, n (%) | 6 (6.5) | 2 (2.3) | .28 |
| Placental abruption, n (%) | 0 (0) | 0 (0) | 1 |
| Small for gestational age (<10th percentile), n (%) | 1 (1) | 3 (3.4) | .36 |
| Premature delivery, n (%) | 7 (7.6) | 7 (7.9) | 1 |
| ≥24 to <28 weeks, n | 1 | 0 | |
| ≥28 to < 32 weeks, n | 0 | 2 | |
| ≥32 to < 37 weeks, n | 6 | 5 | |
| Multiple gestation, n (%) | 1 (1) | 0 (0) | 1 |
| Outcomes of pregnancies with live birth | |||
| N | 92 | 86 | |
| Birth weight‖, g (mean [SD]) | 3283 (554) | 3142 (537) | .09 |
| Gestation time at delivery, weeks (mean [SD]) | 39.3 (2.2) | 38.9 (2.3) | .24 |
Placebo group: 1 arthrogryposis, 1 polymalformative syndrome, and 1 hydronephrosis. Enoxaparin group: 1 trisomy 21, 1 polymalformative syndrome, 1 neonatal epilepsy, 1 interventricular communication, 1 hairless line, 1 congenital nevus, 1 ear lobe anomaly.
The injections were stopped for 10 or more days when hemorrhage occurred.
Maternal thrombocytopenia was defined as a platelet count <0.6× baseline platelet count or as a platelet count <100 000/mm3. No heparin-induced thrombocytopenia was observed.
Medically-indicated termination of pregnancy as a result of a congenital abnormality cited in the first footnote.
One missing data.