Clinical Outcomes with the LMWH, Tinzaparin (Innohep®) in Pregnancy. An International Retrospective Audit..
Bibliographic record
Abstract
Abstract Abstract 487 Low molecular weight heparins (LMWH) have become the parenteral anticoagulant of choice in pregnancy in most current guidelines1. Several small series of clinical experiences with the LMWH, tinzaparin (Innohep®) in pregnancy have been published and there is data on its pharmacokinetics in pregnancy2, but to date there have been no large audits of its efficacy and safety in pregnancy. The aim of this project was to gather this data retrospectively by reviewing maternal and fetal outcomes in consecutive pregnancies in which the mother was treated with tinzaparin, in 8 countries (UK, Ireland, Denmark, Sweden, Spain, Canada, Holland and Belgium). Using a standard Case Report Form, the hospital staff were asked to start with the most recent pregnancy with an outcome (birth, miscarriage, still birth) in which the mother had any exposure to tinzaparin whilst pregnant and then to work backwards recording consecutive relevant pregnancies (not including the use of tinzaparin solely for prophylaxis at Caesarian section). The data below is provisional, but unlikely to change substantially. Data were gathered from 1270 pregnancies with a total of 1298 fetuses. The mean prophylactic dose was 6,469 IU (median = 4,500 IU, SD 3,618 IU) daily and the mean treatment dose was 12,761 IU (median = 12,871 IU, SD 3,915 IU) daily. From 1180 of the total population, the mean duration of treatment was 150 days (median = 171 SD = 76). There were 797 (62.8%) vaginal deliveries with 368 (29.0%) caesarian sections, 49 (3.9%) involved ventouse/vacuum and 29 (2.3%) with forceps assistance (data missing for 27(2.1%)). Of the births, 47.5% were induced and 45.7% were spontaneous (data missing for 6.8%). Epidural/spinal anesthesia was administered in 39.1% with no epidural haematoma. Blood loss at delivery was considered normal in 1020 (80.3%) of cases, abnormal in 40 (3.1%) and this data was missing in 210 (16.5%). In total there were 39 miscarriages and 1,259 births, of which 14 (1.1%) were still births and 1245 (98.9%) live births. There were no maternal deaths, no neonatal hemorrhages and 6 (0.5%) neonatal deaths. Of the neonatal deaths, 4 occurred in babies born at 24 weeks of gestation or earlier, 1 at 27 weeks gestation and the remaining case had Ebstein's anomaly. Congenital abnormalities were reported in 26 (2.1%) cases. In addition, a further infant (reported as a neonatal death) died 7 weeks after birth due to respiratory distress. Although these were pregnancies with significantly higher risks of maternal and foetal morbidity and mortality, the rate of neonatal deaths in this audit (0.5%) is close to the reported figure (0.34%) for all pregnancies in 2006 for the UK3. Likewise the stillbirth rate in this audit was 1.1% against a reported figure of 0.53% for all pregnancies in the UK in 20063. Venous Thrombo Embolism (VTE) treatment doses of tinzaparin were administered in 19.8% and prophylactic doses in 80.2%. Results on (re)occurrence of VTE, major bleed, heparin induced thrombocytopenia and osteoporotic fracture are currently being analysed. These preliminary results provide reassuring maternal and fetal outcome information in pregnancies exposed to tinzaparin. This audit will add further to the knowledge of the safety and efficacy of tinzaparin in pregnancy, as used by clinicians in non clinical trial practice. Marik P and Plante L.A. Venous Thromboembolic Disease and pregnancy.N. Engl J Med, 2008;359:2025-33. Smith M. et al. Tinzaparin Sodium for thrombosis treatment and prevention during pregnancy. AJOG, 2004; 190: 495-501 Perinatal Mortality 2006, England, Wales and N.Ireland, CEMACH Publication 2008 Disclosures: Rodger: Leo Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; Sanofi Aventis: Research Funding. Off Label Use: Tinzaparin in pregnancy to prevent and treat venous thrombosis. Nelson-Piercy:Leo Pharma: Adjudication Committee. Powrie:Leo Pharma: Adjudication Committee. Borg:Leo Pharma: Adjudication Committee. Greer:Leo Pharma: Adjudication Committee.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".