None listed
Conditions
Brief summary
Objective :To determine maternal (included thromboembolic and haemorrhagic complications) and fetal outcomes(included miscarriage, stillbirth, baby death and live birth) in women with mechanical heart valves managed with therapeutic dose unfractionated Heparin (UFH) versus enoxaparin during pregnancy. Methods: this is a prospective comparative, non-randomized study.Pregnant women with mechanical heart valves attending high-risk pregnancy unit high-Benha university hospital, treated with Unfractionated Heparin (UFH) 15,000 U /12 h versus enoxaparin (Clexane) 1mg/kg subcutaneously /12h during pregnancy. Results: 40 pregnant. In 20 pregnancies anticoagulation was with Unfractionated Heparin (UFH) and 20 pregnancies women received enoxaparin. One (3%) thrombotic complications occurred with enoxaparin treatment. Non-compliance or sub-therapeutic levels contributed in this case. Antenatal hemorrage occurred in 4 (10%) and postpartum haemorrhagic complications in 5 (12.5%) pregnancies. Of 32 pregnancies continued after 20 weeks’ gestation, 100% (17/17) of women taking predominantly Unfractionated Heparin (UFH) had a surviving infant compared with 93% (14/15) in women taking primarily enoxaparin(p equal to 0.25). One intrauterine fetal death (IUFD) occurred in enoxaparin group. There was no significant difference in live birth rate between the two groups (p equal to 0.31). Conclusions: Compliance with therapeutic dose Unfractionated Heparin (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. Keywords: enoxaparin, prosthetic heart valves, UFH, pregnancy, thromboembolism.
Interventions
Women were reviewed urgently upon confirmation of pregnancy (at booking) to discuss with them treatment options and the risks of continuing the pregnancy. Women were informed of both the maternal and fetal risks associated with anticoagulant regimen choices and fully participated in the decision process of anticoagulation.
After her choice of one of the following treatment options each pregnant woman completed written informed consent:
A). Replacement of warfarin with therapeutic dose UFH (15
Women were reviewed urgently upon confirmation of pregnancy (at booking) to discuss with them treatment options and the risks of continuing the pregnancy. Women were informed of both the maternal and fetal risks associated with anticoagulant regimen choices and fully participated in the decision process of anticoagulation. After her choice of one of the following treatment options each pregnant woman completed written informed consent: A). Replacement of warfarin with therapeutic dose UFH (15.000 IU/twice daily given subcutaneously) before 6 weeks’ gestation, continued throughout pregnancy but stopped 12 hours before delivery is anticipated and can be restarted, in the absence of hemorrhagic problems, 4 to 6 hours after delivery. B). Replacement of warfarin with therapeutic dose enoxaparin (1 mg/kg twice daily given subcutaneously ) before 6 weeks’ gestation, continued until 36th week gestation then shift to UFH until delivery by 15.000 IU/twice daily given subcutaneously .In the intrapartum setting, heparin injection should be stopped 12 hours before delivery is anticipated and can be restarted, in the absence of hemorrhagic problems, 4 to 6 hours after delivery. During (UFH) treatment group A, the activated partial thromboplastin time (aPTT) was maintained at twice the control level. For women in enoxaparin group(B), monitoring of anti-Xa levels was recommended every month, our aim for target levels of Anti-Xa was 0.7 to 1.2 IU/ml /4 hours post dose . Anti-Xa levels were first checked 3–7 days after starting treatment or following dose modification and then repeated monthly at routine prenatal visits, adjusting the level upward or downward as necessary Thus, we had two study groups according to the anticoagulation regimen. A total of 20 patients were on UFH throughout their pregnancy (group A). The remaining 20 patients (group B) had enoxaparin till the 36th week of gestation followed by heparin for the last two weeks of pregnancy; heparin stopped 12 hours before delivery is anticipated and can be restarted, in the absence of hemorrhagic problems, 4 to 6 hours after delivery.
Sponsors
khalid abd aziz mohamed
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
40 pregnant women with prosthetic heart valves were followed in the high-risk pregnancy unit- Benha university hospital and were interviewed about their medical, personal, family, obstetrical and thrombosis history.
Exclusion criteria
none
Outcome results
None listed