ORCID Profile
0000-0001-9764-6876
Current Organisation
University of Nottingham
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Publisher: Wiley
Date: 07-04-2016
DOI: 10.1111/AOGS.12877
Publisher: Wiley
Date: 21-04-2022
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2016
DOI: 10.1161/HYPERTENSIONAHA.116.07862
Abstract: To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for hours) and secondary outcomes (serious maternal complications), birth weight th percentile, preecl sia, delivery at or weeks, platelets ×10 9 /L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission ( P =0.20): CHIPS primary outcome, birth weight th percentile, preecl sia, preterm delivery, elevated liver enzymes (all P .001), platelets ×10 9 /L ( P =0.006), and prolonged hospital stay ( P =0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control ( P =0.02). Adjustment for preecl sia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome ( P .001), birth weight th percentile ( P =0.005), delivery at ( P .001) or weeks ( P .001), or elevated liver enzymes with symptoms ( P =0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preecl sia co-occurrence. URL: pre-empt.cfri.ca/ . Unique identifier: ISRCTN 71416914. URL: www.clinicaltrials.gov/ . Unique identifier: NCT01192412.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2016
DOI: 10.1161/HYPERTENSIONAHA.116.07466
Abstract: The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned “less tight” (target diastolic 100 mm Hg) and “tight” (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean total cost per woman–infant dyad was higher in less tight versus tight control, but the difference in mean total cost (DM) was not statistically significant in any province: Ontario ($30 191.62 versus $24 469.06 DM $5723, 95% confidence interval, −$296 to $12 272 P =0.0725) British Columbia ($30 593.69 versus $24 776.51 DM $5817 95% confidence interval, −$385 to $12 349 P =0.0725) or Alberta ($31 510.72 versus $25 510.49 DM $6000.23 95% confidence interval, −$154 to $12 781 P =0.0637). Tight control may benefit women without increasing risk to neonates (as shown in the main CHIPS trial), without additional (and possibly lower) cost to the healthcare system. URL: www.clinicaltrials.gov . Unique identifier: NCT01192412.
Publisher: Elsevier BV
Date: 12-2020
Publisher: Wiley
Date: 20-08-2015
Publisher: Elsevier BV
Date: 11-2016
DOI: 10.1016/J.EJOGRB.2016.07.509
Abstract: To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412). Quantitative and qualitative analysis of questionnaire responses. International randomised trial (94 sites, 15 countries). 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85mmHg) or 'less tight' (target diastolic blood pressure, 100mmHg) who completed questionnaires. A questionnaire was administered at ∼6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site co-ordinator, and contact was made by phone, home or clinic visit rarely, data was collected from medical records. Quantitative analyses were Chi-square or Fisher's exact test for categorical variables, mixed effects multinomial logistic regression to adjust for confounders, and p<0.001 for statistical significance. NVivo software was used for thematic analysis of women's views. Satisfaction, measured as willingness to have the same treatment in another pregnancy or recommend that treatment to a friend. Among the 533 women in 'tight' (N=265) vs. 'less tight' (N=268) control who provided comments for qualitative analysis, women in 'tight' (vs. 'less tight') control made fewer positive comments about the amount of medication taken (5 vs. 28 women, respectively) and intensity of BP monitoring (7 vs. 17, respectively). However, this did not translate into less willingness to either have the same treatment in another pregnancy (434, 95.8% vs. 423, 92.4%, respectively p=0.14) or recommend that treatment to a friend (435, 96.0% and 428, 93.4%, respectively p=0.17). Importantly, although satisfaction remained high among women with an adverse outcome, those in 'tight' control who suffered an adverse outcome (vs. those who did not) were not consistently less satisfied, whereas this was not the case among women in 'less tight' control among whom satisfaction was consistently lower for the CHIPS primary outcome (p<0.001), severe hypertension (p≤0.01), and pre-ecl sia (p<0.001). Women in 'tight' (vs. 'less tight') control were equally satisfied with their care, and more so in the face of adverse perinatal or maternal outcomes.
Publisher: Springer Science and Business Media LLC
Date: 30-03-2017
Publisher: Wiley
Date: 11-08-2015
Abstract: To compare pregnancy outcomes, accounting for allocated group, between methyldopa-treated and labetalol-treated women in the CHIPS Trial (ISRCTN 71416914) of 'less tight' versus 'tight' control of pregnancy hypertension. Secondary analysis of CHIPS Trial cohort. International randomised controlled trial (94 sites, 15 countries). Of 987 CHIPS recruits, 481/566 (85.0%) women treated with antihypertensive therapy at randomisation. Of 981 (99.4%) women followed to delivery, 656/745 (88.1%) treated postrandomisation. Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors. CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight <10th centile, severe maternal hypertension, pre-ecl sia and delivery at <34 or <37 weeks. Methyldopa and labetalol were used commonly at randomisation (243/987, 24.6% and 238/987, 24.6%, respectively) and post-randomisation (224/981, 22.8% and 433/981, 44.1%, respectively). Following adjusted analyses, methyldopa (versus labetalol) at randomisation was associated with fewer babies with birthweight <10th centile [adjusted odds ratio (aOR) 0.48 95% CI 0.20-0.87]. Methyldopa (versus labetalol) postrandomisation was associated with fewer CHIPS primary outcomes (aOR 0.64 95% CI 0.40-1.00), birthweight <10th centile (aOR 0.54 95% CI 0.32-0.92), severe hypertension (aOR 0.51 95% CI 0.31-0.83), pre-ecl sia (aOR 0.55 95% CI 0.36-0.85), and delivery at <34 weeks (aOR 0.53 95% CI 0.29-0.96) or <37 weeks (aOR 0.55 95% CI 0.35-0.85). These nonrandomised comparisons are subject to residual confounding, but women treated with methyldopa (versus labetalol), particularly those with pre-existing hypertension, may have had better outcomes. There was no evidence that women treated with methyldopa versus labetalol had worse outcomes.
Publisher: Wiley
Date: 11-08-2015
Abstract: To determine whether the difference in outcomes between 'less tight' (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) in the CHIPS Trial (ISRCTN 71416914, pre-empt.cfri.ca/ CHIPS) depended on the choice of labetalol or methyldopa, the two most commonly used antihypertensive agents in CHIPS. Secondary analysis of CHIPS Trial data. International multicentre randomised controlled trial (94 sites, 15 countries). A total of 987 women with non-severe non-proteinuric pregnancy hypertension. Logistic regression was used for comparisons of 'less tight' versus 'tight' control among women treated with labetalol (but not methydopa) versus methyldopa (but not labetalol). Analyses were adjusted for the influence of baseline factors, including use of any antihypertensive therapy at randomisation. Main CHIPS Trial outcomes: primary (perinatal loss or high-level neonatal care for > 48 hours), secondary (serious maternal complications), birthweight < 10th centile, severe maternal hypertension, pre-ecl sia, and delivery at < 34 or < 37 weeks. Of 987 women in CHIPS, antihypertensive therapy was taken by 566 women at randomisation (labetalol 111 ['less tight'] versus 127 ['tight'] or methyldopa 126 ['less tight'] versus 117 ['tight']) and 815 women after randomisation (labetalol 186 ['less tight'] versus 247 ['tight'] and methyldopa by 98 ['less tight'] versus 126 ['tight']). Following adjustment, odds ratios for outcomes in 'less tight' versus 'tight' control were similar between antihypertensive groups according to 'at randomisation' and 'after randomisation' therapy. Outcomes for 'less tight' versus 'tight' control were not dependent on use of methyldopa or labetalol. In the CHIPS Trial, maternal and infant outcomes were not dependent on use of labetalol or methyldopa.
Publisher: National Institute for Health and Care Research
Date: 12-2020
DOI: 10.3310/EME07090
Abstract: Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and raised serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment, but without an adequate evidence base. We aimed to evaluate whether or not ursodeoxycholic acid reduces adverse perinatal outcomes in affected women. Multicentre, masked, randomised, placebo-controlled, two-arm, parallel-group trial. Thirty-three UK maternity units. Women with intrahepatic cholestasis of pregnancy aged ≥ 18 years, between 20 +0 and 40 +6 weeks’ gestation with a singleton or twin pregnancy and no known lethal fetal anomaly. Women were randomly assigned (1 : 1 allocation ratio) to take ursodeoxycholic acid tablets or matched placebo tablets, at an equivalent dose of 1000 mg daily, titrated as needed. The primary outcome was a composite of perinatal death (in utero fetal death after randomisation or known neonatal death up to 7 days) or preterm delivery ( 37 weeks’ gestation) or neonatal unit admission for at least 4 hours (from birth until hospital discharge). Each infant was counted once within this composite. Analyses were by intention to treat. Between 23 December 2015 and 7 August 2018, 605 women were randomised, with 305 women allocated to the ursodeoxycholic acid arm and 300 women to the placebo arm. There was no evidence of a significant difference in the incidence of the primary outcome between the groups: 23.0% (74 out of 322 infants) in the ursodeoxycholic acid group compared with 26.7% (85 out of 318 infants) in the placebo group adjusted risk ratio 0.85 (95% confidence interval 0.62 to 1.15). There was no evidence of a significant difference in total costs (maternal, infant and the cost of ursodeoxycholic acid) between the two trial groups. There were two serious adverse events in the ursodeoxycholic acid group and six in the placebo group. Limitations include a primary outcome event rate in the control group that was lower than that estimated for the s le size calculation, but the lack of evidence of effect in all analyses suggests that it is unlikely that the trial had insufficient power. In this clinical trial of ursodeoxycholic acid in women with intrahepatic cholestasis of pregnancy, there is no evidence that it is effective in reducing a composite of adverse perinatal outcomes. Future research should aim to elucidate the aetiology and pathophysiology of adverse perinatal outcomes, particularly stillbirth, in women with intrahepatic cholestasis of pregnancy to assist the development of an effective preventative treatment. Further exploratory analyses may identify groups of women who might respond to ursodeoxycholic acid treatment. Current Controlled Trials ISRCTN91918806. This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation Vol. 7, No. 9. See the NIHR Journals Library website for further project information.
Publisher: Massachusetts Medical Society
Date: 29-01-2015
Publisher: Wiley
Date: 25-02-2021
Abstract: To examine the association between pre‐ecl sia definition and pregnancy outcome. Secondary analysis of Control of Hypertension in Pregnancy Study (CHIPS) trial data. International multicentre randomised controlled trial (RCT). In all, 987 women with non‐severe non‐proteinuric pregnancy hypertension. We evaluated the association between pre‐ecl sia definitions and adverse pregnancy outcomes, stratified by hypertension type and blood pressure control. Main CHIPS trial outcomes: primary (perinatal loss or high‐level neonatal care for hours), secondary (serious maternal complications), birthweight th centile, severe maternal hypertension, delivery at or weeks, and maternal hospitalisation before birth. Of 979/987 women with informative data, 280 (28.6%) progressed to pre‐ecl sia defined restrictively by new proteinuria, and 471 (48.1%) to pre‐ecl sia defined broadly as proteinuria or one/more maternal symptoms, signs or abnormal laboratory tests. The broad (versus restrictive) definition had significantly higher sensitivities (range 62–79% versus 36–50%), lower specificities (range 53–65% versus 72–82%), and similar or higher diagnostic odds ratios and ‘true‐positive’ to ‘false‐positive’ ratios. Stratified analyses showed similar results. Addition of available fetoplacental manifestations (stillbirth or birthweight th centile) to the broad pre‐ecl sia definition improved sensitivity (74–87%). A broad (versus restrictive) pre‐ecl sia definition better identifies women who develop adverse pregnancy outcomes. These findings should be replicated in a prospective study within routine healthcare to ensure that the anticipated increase in surveillance and intervention in a larger number of women with pre‐ecl sia is associated with improved outcomes, reasonable costs and congruence with women's values. A broad (versus restrictive) pre‐ecl sia definition better identifies the risk of adverse pregnancy outcomes.
Publisher: Wiley
Date: 08-12-2019
DOI: 10.1111/AOGS.13771
Publisher: Springer Science and Business Media LLC
Date: 16-05-2009
Publisher: Springer Science and Business Media LLC
Date: 06-01-2015
Publisher: Elsevier BV
Date: 06-2020
Publisher: Elsevier BV
Date: 12-2020
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Jim Thornton.