Abstract
OBJECTIVE: This study was carried out to determine the maternal (including thromboembolic and hemorrhagic complications) and fetal outcomes (including miscarriage, stillbirth, baby death, and live birth) in women with mechanical heart valves managed with therapeutic doses of unfractionated heparin (UFH) versus enoxaparin during pregnancy. METHODS: This is a prospective comparative, nonrandomized study. Pregnant women with mechanical heart valves presenting to high-risk pregnancy unit of Benha University Hospital, Egypt were treated with UFH 15,000 U/12 h versus enoxaparin (Clexane) 1 mg/kg SC/12 h during pregnancy and the results were analyzed. RESULTS: 40 pregnant women were included in the study. In 20 pregnant women, anticoagulation was with UFH, and 20 pregnant women received enoxaparin. One (3 %) thrombotic complication occurred with enoxaparin treatment. Noncompliance or subtherapeutic levels contributed to this outcome in this case. Antenatal hemorrhage occurred in 4 (10 %) and postpartum hemorrhagic complications in 5 (12.5 %) pregnancies. Of the 32 pregnant women who continued after 20 weeks' gestation, 100 % (17/17) of the women taking predominantly UFH had a surviving infant compared with 93 % (14/15) of the women taking primarily enoxaparin (p = 0.25). One intrauterine fetal death occurred in the enoxaparin group. There was no significant difference in the live birth rates between the two groups (p = 0.31). CONCLUSIONS: Compliance with therapeutic dose of UFH during pregnancy in women with mechanical heart valves is associated with a low risk of valve thrombosis and good fetal outcomes, but meticulous monitoring is essential.