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.
Background: The presented evidence-based clinical practice guideline (CPG) is proposed as a National CPG using an evidence-based and formal CPG adaptation methodology. The purpose of this study was to adapt the international CPGs' recommendations for term and late preterm neonates with severe hyperbilirubinemia to suit the healthcare system in the Egyptian context. This CPG provides a framework for prediction, prevention and management of severe hyperbilirubinemia in newborn infants of 35 or more weeks of gestation. The quality of evidence and strength of recommendations are indicated. The guideline adaptation group was chosen from various Egyptian Universities. There was an active involvement of a Multidisciplinary Review Committee following a standardized process. The Neonatology Guideline Adaptation Group (NGAG) was assigned individual health questions to cover the different sections of the required CPG. A literature search for source CPGs was carried out. The NGAG studied several guidelines. Critical appraisal was done by AGREE II (Appraisal of Guidelines for Research and Evaluation) Instrument to rate and select the appropriate guidelines. Results: The NGAG decided to adapt mainly the American Academy of Pediatrics Guideline (2004Guideline ( , 2009Guideline ( & 2011 and for the questions which were not answered; the best and most relevant evidence available was used.Implementation tools were sought for to facilitate the application of the adapted CPG. Conclusion: The finalized CPG offers healthcare providers with applicable evidence-based guidance for severe neonatal hyperbilirubinemia in the Egyptian context. The Adapted ADAPTE method emphasized the value of collaborative clinical and methodological expert groups' efforts for adaptation of national guidelines.
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