Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period.

BACKGROUND: Venous thromboembolism (VTE), although rare, is a major cause of maternal mortality and morbidity, and methods of prophylaxis are therefore often used for women considered to be at risk. This may include women who have given birth by caesarean section, those with a personal or family history of VTE and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry risks of adverse effects, and as the risk of VTE is often low, it is possible that the benefits of thromboprophylaxis may be outweighed by harms. Guidelines for clinical practice have been based on expert opinion rather than high-quality evidence from randomised trials. OBJECTIVES: To assess the effects of thromboprophylaxis in women who are pregnant or have recently given birth and are at increased risk of VTE on the incidence of VTE and adverse effects of treatment. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 November 2013).  SELECTION CRITERIA: Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis. DATA COLLECTION AND ANALYSIS: At least two review authors assessed trial eligibility and quality and extracted the data. MAIN RESULTS: Nineteen trials, at an overall moderate risk of bias, met the inclusion criteria for the review. Only 16 trials, involving 2592 women, assessing a range of methods of thromboprophylaxis, contributed data to the review. Six trials compared methods of antenatal prophylaxis: heparin versus no treatment/placebo (two trials), and low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) (four trials). Nine trials assessed prophylaxis after caesarean section: four compared heparin with placebo; three compared LMWH with UFH; one compared hydroxyethyl starch (HES) with UFH; and one compared five-day versus 10-day LMWH. One study examined prophylaxis with UFH in the postnatal period (including following vaginal births).For antenatal prophylaxis, none of the included trials reported on maternal mortality, and no differences were detected for the other primary outcomes of symptomatic thromboembolic events, symptomatic pulmonary embolism (PE) and symptomatic deep venous thrombosis (DVT) when LMWH or UFH was compared with no treatment/placebo or when LMWH was compared with UFH. The risk ratios (RR) for symptomatic thromboembolic events were: antenatal LMWH/UFH versus no heparin, RR 0.33; 95% confidence interval (CI) 0.04 to 2.99 (two trials, 56 women); and antenatal LMWH versus UFH, RR 0.47; 95% CI 0.09 to 2.49 (four trials, 404 women). No differences were shown when antenatal LMWH or UFH was compared with no treatment/placebo for any secondary outcomes. Antenatal LMWH was associated with fewer adverse effects sufficient to stop treatment (RR 0.07; 95% CI 0.01 to 0.54; two trials, 226 women), and fewer fetal losses (RR 0.47; 95% CI 0.23 to 0.95; three trials, 343 women) when compared with UFH. In two trials, antenatal LMWH compared with UFH was associated with fewer bleeding episodes (defined in one trial of 121 women as bruises > 1 inch (RR 0.18, 95% CI 0.09 to 0.36); and in one trial of 105 women as injection site haematomas of ≥ 2 cm, bleeding during delivery or other bleeding (RR 0.28; 95% CI 0.15 to 0.53)), however in a further trial of 117 women no difference between groups was shown for bleeding at delivery. The results for these secondary outcomes should be interpreted with caution, being derived from small trials that were not of high methodological quality.For post-caesarean/postnatal prophylaxis, only one trial comparing five-day versus 10-day LMWH after caesarean section reported on maternal mortality, observing no deaths. No differences were seen across any of the comparisons for the other primary outcomes (symptomatic thromboembolic events, symptomatic PE and symptomatic DVT). The RRs for symptomatic thromboembolic events were: post-caesarean LMWH/UFH versus no heparin, RR 1.30; 95% CI 0.39 to 4.27 (four trials, 840 women); post-caesarean LMWH versus UFH, RR 0.33; 95% CI 0.01 to 7.99 (three trials, 217 women); post-caesarean five-day versus 10-day LMWH, RR 0.36; 95% CI 0.01 to 8.78 (one trial, 646 women); postnatal UFH versus no heparin, RR 0.16; 95% CI 0.02 to 1.36 (one trial, 210 women). For prophylaxis after caesarean section, in one trial (of 580 women), women receiving UFH and physiotherapy were more likely to have bleeding complications ('complications hémorragiques') than women receiving physiotherapy alone (RR 5.03; 95% CI 2.49 to 10.18). In two additional trials, that compared LMWH with placebo, no difference between groups in bleeding episodes (major bleeding; major bruising; bleeding/bruising reported at discharge) were detected. No other differences in secondary outcomes were shown when LMWH was compared with UFH post-caesarean, nor when post-caesarean HES was compared with UFH, post-caesarean five-day LMWH was compared with 10-day LMWH, or when UFH was compared to no heparin postnatally. AUTHORS' CONCLUSIONS: There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period, with the small number of differences detected in this review being largely derived from trials that were not of high methodological quality. Large scale, high-quality randomised trials of currently used interventions are warranted.

Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period.

BACKGROUND: Venous thromboembolic disease (TED), although rare, is a major cause of maternal mortality and morbidity, hence methods of prophylaxis are often used for women at risk. This may include women delivered by caesarean section, those with a personal or family history of TED and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry a risk of side effects, and as the risk of TED is low, it is possible that the benefits of thromboprophylaxis may be outweighed by harm. Current guidelines for clinical practice are based on expert opinion only, rather than high quality evidence from randomised trials. OBJECTIVES: To determine the effects of thromboprophylaxis in women who are pregnant or have recently delivered and are at increased risk of TED on the incidence of venous TED and side effects of treatment. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009). SELECTION CRITERIA: Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently and resolved any discrepancies by discussion. MAIN RESULTS: Sixteen trials met the inclusion criteria but only 13 trials, involving 1774 women, examining a range of methods of thromboprophylaxis, contributed data for the outcomes of interest. Four of them compared methods of antenatal prophylaxis: low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) (two studies), and heparin versus no treatment (two studies). Eight studies assessed postnatal prophylaxis after caesarean section; one compared hydroxyethyl starch with unfractionated heparin; four compared heparin with placebo; and the other three compared UFH with LMWH. One study examined prophylaxis in the postnatal period.The small number of statistically significant findings in this review are largely derived from trials which are not of high methodological quality. It was not possible to assess the effects of any of these interventions on most outcomes, and especially on rare outcomes such as death, TED and osteoporosis, because of small sample sizes and the small number of trials making the same comparisons.There was some evidence of side effects associated with thromboprophylaxis. AUTHORS' CONCLUSIONS: There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period. Large scale randomised trials of currently-used interventions should be conducted.

Public views on healthcare performance indicators and patient choice.

Patients on certain waiting lists in the UK National Health Service (NHS) are now offered the choice of persevering with their home hospital or switching to another hospital where they will be treated on a guaranteed date. Such decisions require knowledge of performance. We used facilitated focus groups to investigate the views of patients and members of the public on publication of information about the performance of healthcare providers. Six groups with a total of 50 participants met in six different locations in England. Participants felt that independent monitoring of healthcare performance is necessary, but they were ambivalent about the value of performance indicators and hospital rankings. They tended to distrust government information and preferred the presentational style of 'Dr Foster', a commercial information provider, because it gave more detailed locally relevant information. Many participants felt the NHS did not offer much scope for choice of provider. If public access to performance information is to succeed in informing referral decisions and raising quality standards, the public and general practitioners will need education on how to interpret and use the data.