Browsing by Author "Cluver, Catherine Anne"
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- ItemDouble blind, randomised, placebocontrolled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial) : a study protocol(BMJ Publishing Group, 2015) Cluver, Catherine Anne; Walker, Susan P.; Mol, Ben W.; Theron, Gerard B.; Hall, David R.; Hiscock, Richard; Hannan, N.; Tong, S.Introduction: Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far greater numbers of fetal losses. There is no definitive treatment other than delivery. A drug that can quench the disease process could be useful to treat early onset pre-eclampsia, as it could allow pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have generated preclinical data to show esomeprazole, a proton pump inhibitor used for gastric reflux, has potent biological effects that makes it a worthwhile therapeutic candidate. Esomeprazole potently decreases soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin secretion from placenta and endothelial cells, and has biological actions to mitigate endothelial dysfunction and oxidative stress. Methods and analysis: We propose undertaking a phase II, double blind, randomised controlled clinical trial to examine whether administering 40 mg esomeprazole daily may prolong gestation in women with early onset pre-eclampsia. We will recruit 120 women (gestational age of 26+0 to 31+6 weeks) who will be randomised to receive either esomeprazole or an identical placebo. The primary outcome will be the number of days from randomisation to delivery. Secondary outcomes include maternal, fetal and neonatal composite and individual outcomes. Maternal outcomes include maternal death, eclampsia, pulmonary oedema, severe renal impairment, cerebral vascular events and liver haematoma or rupture. Neonatal outcomes include neonatal death within 6 weeks after the due date, intraventricular haemorrhage, necrotising enterocolitis and bronchopulmonary dysplasia. We will examine whether esomeprazole can decrease serum sFlt-1 and soluble endoglin levels and we will record the safety of esomeprazole in these pregnancies. Ethics and dissemination: This study has ethical approval (Protocol V.2.4, M14/09/038, Federal Wide assurance Number 00001372, IRB0005239), and is registered with NHREC (ID 3649) and the Pan African Clinical Trial Registry (PACTR201504000771349). Data will be presented at international conferences and published in peer-reviewed journals.
- ItemInterventions for helping to turn term breech babies to head first presentation when using external cephalic version(Cochrane, 2015-02-12) Cluver, Catherine Anne; Gyte, Gillian M. L.; Sinclair, Marlene; Dowswell, Therese; Hofmeyr, George JustusBackground: Breech presentation is associated with increased complications. Turning a breech baby to head first presentation using external cephalic version (ECV) attempts to reduce the chances of breech presentation at birth so as to avoid the adverse effects of breech vaginal birth or caesarean section. Interventions such as tocolytic drugs and other methods have been used in an attempt to facilitate ECV. Objectives: To assess, from the best evidence available, the effects of interventions such as tocolysis, acoustic stimulation for midline spine position, regional analgesia (epidural or spinal), transabdominal amnioinfusion, systemic opioids and hypnosis, or the use of abdominal lubricants, on ECV at term for successful version, presentation at birth, method of birth and perinatal and maternal morbidity and mortality.
- ItemMaternal position during caesarean section for preventing maternal and neonatal complications : a cochrane review(Stellenbosch : Stellenbosch University, 2011-12) Cluver, Catherine Anne; Hall, D. R.; Hofmeyr, G. J.; Stellenbosch University. Faculty of Health Sciences. Dept. of Obstetrics and Gynaecology.ENGLISH ABSTRACT: Background: During caesarean section mothers can be in different positions. Theatre tables could be tilted laterally, upwards, downwards or flexed and wedges or cushions could be used. There is no consensus on the best positioning at present. Objectives: We assessed all available data on positioning of the mother to determine if there is an ideal position during caesarean section that would improve outcomes. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (September 2009), PubMed (1966 to 14 September 2009) and manually searched the references of retrieved articles. Selection criteria: Randomised trials of women undergoing caesarean section comparing different positions. Data collection and analysis: Two authors assessed eligibility, trial quality and extracted data. Results: We identified 17 studies with a total of 683 woman included. We included nine studies and excluded eight studies. Included trials were of variably quality with small sample sizes. Most comparisons had data from single trials. This is a shortcoming and applicability of results is limited. The incidence of air embolism was not affected by head up versus horizontal position (risk ratio (RR) 0.91; 95% confidence interval (CI) 0.65 to 1.26). We found no change in hypotensive episodes when comparing left lateral tilt (RR 0.11; 95% CI 0.01 to 1.94), right lateral tilt (RR 1.25; 95% CI 0.39 to 3.99) and head down tilt (mean difference (MD) -3.00; 95% CI -8.38 to 2.38) with horizontal positions or full lateral tilt with 15-degree tilt (RR 1.20; 95% CI 0.80 to 1.79). Hypotensive episodes were decreased with manual displacers (RR 0.11; 95% CI 0.03 to 0.45), a right lumbar wedge compared to a right pelvic wedge (RR 1.64; 95% CI 1.07 to 2.53) and increased in right lateral tilt (RR 3.30; 95% CI 1.20 to 9.08) versus left lateral tilt. Position did not affect systolic blood pressure when comparing left lateral tilt (MD 2.70; 95% CI -1.47 to 6.87) or head down tilt (RR 1.07; 95% CI 0.81 to 1.42) to horizontal positions, or full lateral tilt with 15-degree tilt (MD -5.00; 95% CI -11.45 to 1.45). Manual displacers showed decreased fall in mean systolic blood pressure compared to left lateral tilt (MD -8.80; 95% CI -13.08 to -4.52). Position did not affect diastolic blood pressures when comparing left lateral tilt versus horizontal positions. (MD-1.90; 95% CI -5.28 to 1.48). The mean diastolic pressure was lower in head down tilt (MD -7.00; 95% CI -12.05 to -1.95) when compared to horizontal positions. There were no statistically significant changes in maternal pulse rate, five-minute Apgars, maternal blood pH or cord blood pH when comparing different positions. Authors' conclusions There is limited evidence to support or clearly disprove the value of the use of tilting or flexing the table, the use of wedges and cushions or the use of mechanical displacers. Larger studies are needed.
- ItemThe Preeclampsia intervention with Esomeprazole (PIE) trial: A double blind, randomised, placebo-controlled trial to treat early onset severe preeclampsia(Stellenbosch : Stellenbosch University, 2019-04) Cluver, Catherine Anne; Theron, Gerhardus Barnard; Walker, Susan; Tong, Stephen; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Obstetrics and Gynaecology.ENGLISH ABSTRACT: This body of work addresses the clinical dilemma posed by preterm preeclampsia. Firstly, we tested a potential therapeutic (esomeprazole) for the treatment of early preterm preeclampsia in a double-blind randomised controlled trial. The primary outcome of interest was prolongation of gestation, with secondary outcomes including maternal and perinatal outcomes. Importantly, this study was underpinned by extensive pharmacokinetic and biomarker studies on both plasma samples and placental tissue. We found that a daily dose of 40mg of esomeprazole did not prolong pregnancy in early preterm preeclampsia and there were no differences in maternal or neonatal outcomes or markers of endothelial dysfunction. The esomeprazole concentrations that were observed in our participants were within the lower range of concentrations used in our preclinical in vitro studies. We therefore concluded that 40 mg may not have been sufficient to have efficacy in treating preterm preeclampsia, and future studies should consider the role of a higher dose or intravenous administration, which has a higher exposure over time and peak concentration. Secondly, we assessed the impact of coexisting fetal growth restriction on pregnancy latency, obstetric, maternal and perinatal outcomes among women undergoing expectant management of early preterm preeclampsia. We found that the latency-to-delivery interval was significantly shorter among pregnancies with coexisting fetal growth restriction. These pregnancies were less likely to reach 34 weeks gestation and more likely to be delivered for suspected fetal compromise. More women with coexisting fetal growth restriction underwent an emergency caesarean section without a trial of labour induction and of those considered eligible for induction of labour, the rate of emergency caesarean section was higher among those with fetal growth restriction. Postnatally, the presence of coexisting fetal growth restriction was associated with a higher rate of postnatal death and necrotising enterocolitis. Interestingly, the rate of maternal complications did not differ between the groups. We concluded that coexisting fetal growth restriction, diagnosed at the same time as preeclampsia, is an important determinant of pregnancy outcome among women being managed expectantly for early preterm preeclampsia Thirdly, we sought to determine the role of expectant management of preeclampsia and the hypertensive disorders of pregnancy after 34 weeks gestation by assimilating the available data in a Cochrane systematic meta-analysis. Based on the limited data available, maternal outcomes appear better with planned early delivery for hypertensive disorders after 34 weeks’ gestation, but it is unclear whether this is associated with increased risks for the baby, especially at earlier gestations. It was not possible to determine whether planned early delivery was beneficial for different hypertensive conditions, particularly preeclampsia. We concluded that further studies are needed, preferably with reliable characterisation of hypertensive disease sub-types, to determine the ideal timing of delivery to optimise maternal and perinatal outcomes for hypertensive disorders of pregnancy occurring after 34 weeks gestation. This research provides new information about a candidate therapeutic for the treatment of preeclampsia. Clinical aspects of the hypertensive disorders of pregnancy that could further improve management are also discussed.
- ItemShoulder dystocia : an update and review of new techniques(Health and Medical Publishing Group, 2009-10) Cluver, Catherine Anne; Hofmeyr, G. JustusENGLISH ABSTRACT: The definition for shoulder dystocia and the incidence varies. Worldwide, shoulder dystocia may be increasing23. In this update we look at the complications for both the mother and fetus. We review the risk factors and strategies for possible prevention. Management options include Mc Roberts position, techniques to deliver the anterior and posterior shoulder and finally salvage maneuvers. Salvage maneuvers which include Posterior Axillary Sling traction (PAST), the Zavanelli Maneuver and fracture of the clavicles. In cases of fetal death associated with an undelivered shoulder dystocia one can consider the transabdominal performance or facilitation of traditional vaginal maneuvers.
- ItemTranexamic acid for preventing postpartum haemorrhage(Cochrane, 2015-06-16) Cluver, Catherine Anne; Novikova, Natalia; Hofmeyr, George JustusBackground: Postpartum haemorrhage (PPH) is a common and potentially life-threatening complication of labour. Several options for preventing PPH are available, but further advances in this field are important, especially the identification of safe, easy to use and cost-effective regimens. Tranexamic acid (TA), which is an antifibrinolytic agent that is used widely to prevent and treat haemorrhage, merits evaluation to assess whether it meets these criteria. Objectives: To determine, from the best available evidence, whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment (with or without uterotonic co-treatment), or to uterotonic agents.