Summary Background Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton ...pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. Methods We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36–41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome—maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. Findings 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0·71, 95% CI 0·59–0·86, p<0·0001). No cases of maternal or neonatal death or eclampsia were recorded. Interpretation Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. Funding ZonMw.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract This article reviews if a restrictive fluid management policy reduces the complication rate if compared to liberal fluid management policy during elective surgery. The PubMed database was ...explored by 2 independent researchers. We used the following search terms: “Blood transfusion (MESH); transfusion need; fluid therapy (MESH); permissive hypotension; fluid management; resuscitation; restrictive fluid management; liberal fluid management; elective surgery; damage control resuscitation; surgical procedures, operative (MESH); wounds (MESH); injuries (MESH); surgery; trauma patients.” A secondary search in the Medline, EMBASE, Web of Science, and Cochrane library revealed no additional results. We selected randomized controlled trials performed during elective surgeries. Patients were randomly assigned to a restrictive fluid management policy or to a liberal fluid management policy during elective surgery. The patient characteristics and the type of surgery varied. All but 3 studies reported American Society of Anaesthesiologists groups 1 to 3 as the inclusion criterion. The primary outcome of interest is total number of patients with a complication and the complication rate. Secondary outcome measures are infection rate, transfusion need, postoperative rebleeding, hospital stay, and renal function. In total, 1397 patients were analyzed (693 restrictive protocol, 704 liberal protocol). Meta-analysis showed that in the restrictive group as compared with the liberal group, fewer patients experienced a complication (relative risk RR, 0.65; 95% confidence interval CI, 0.55-0.78). The total complication rate (RR, 0.57; 95% CI, 0.52-0.64), risk of infection (RR, 0.62; 95% CI, 0.48-0.79), and transfusion rate (RR, 0.81; 95% CI, 0.66-0.99) were also lower. The postoperative rebleeding did not differ in both groups: RR, 0.76 (95% CI, 0.28-2.06). We conclude that compared with a liberal fluid policy, a restrictive fluid policy in elective surgery results in a 35% reduction in patients with a complication and should be advised as the preferred fluid management policy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Summary Background Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in ...women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. Methods We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. Findings 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23% vs 20%, risk ratio RR 1·13, 95% CI 0·87–1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. Interpretation In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. Funding None.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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