Outcomes of severe pre-eclampsia/eclampsia in Yorkshire 1999/2003.

OBJECTIVE: To establish the risk of serious complications from severe pre-eclampsia and eclampsia in a region using a common guideline for the management of these conditions. DESIGN: A five-year prospective study. SETTING: Sixteen maternity units in Yorkshire. POPULATION: All women managed with severe pre-eclampsia and eclampsia. METHODS: A common guideline was developed for the management of women with these conditions. A network of midwives prospectively collected outcome data. MAIN OUTCOME MEASURE: Incidence of the conditions and serious complication rates. RESULTS: A total of 210,631 women delivered in the 16 units between 1 January 1999 and 31 December 2003. One thousand eighty-seven women were diagnosed with severe pre-eclampsia or eclampsia (5.2/1000). One hundred and fifty-one women had serious complications including 82 women (39/10,000) having eclamptic seizures and 49 women (23/10,000) requiring ICU admission. There were no maternal deaths but 54 out of 1145 babies died before discharge, giving a mortality rate of 47.2/1000. Of the 82 cases of eclampsia, 45 occurred antenatally (55%), 18 before admission to the maternity unit. Eleven cases occurred in labour (13%), including 1 during a caesarean section, and 26 cases occurred following delivery (32%). Twenty-five women developed pulmonary oedema (2.3% of cases) and six women required renal dialysis (0.55% of cases). One hundred and sixty-five (15%) required no antihypertensive therapy and 489 (53%) of the remainder required only oral therapy. Two hundred and one (18.5%) required more than one drug. CONCLUSION: A regional guideline for severe pre-eclampsia and eclampsia can be developed and implemented. Its use may contribute to a low rate of serious complications.

Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol.

BACKGROUND: The conventional view that participants in randomised controlled trials sacrifice themselves for the good of future patients is challenged by increasing evidence to suggest that individual patients benefit from participation in trials. OBJECTIVE: To test the hypothesis that trial participants receive higher quality care and, as a consequence, have better outcomes than patients receiving guideline driven routine care. METHODS: Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol. Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia (Magpie Trial); 322 non-participants formed the control group. Indicators of the process of care and clinical outcomes were compared between the two groups. RESULTS: Trial participants were significantly more likely to have received daily blood tests (odds ratio (OR) 6.82, 95% CI 1.62 to 28.72) and had their respiration rate measured hourly (OR 3.42, 95% CI 1.69 to 6.92) than control patients. There were no significant differences in other markers of clinical process and no significant difference in clinical outcomes. CONCLUSION: This study shows minor differences in process markers and no difference in clinical outcomes between patients in a clinical trial and patients receiving protocol driven care. The benefits of improved clinical care that have previously been associated with being in a trial may be explained by the use of clear clinical protocols. In routine practice, patients may be well advised to insist on treatment as part of a protocol.