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1.  The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study) 
Hypertension (Dallas, Tex. : 1979)  2016;68(5):1153-1159.
Supplemental Digital Content is available in the text.
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 >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/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 <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/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 preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), 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 preeclampsia co-occurrence.
Clinical Trial Registration—
URL: Unique identifier: ISRCTN 71416914. URL: Unique identifier: NCT01192412.
PMCID: PMC5058640  PMID: 27620393
antihypertensive therapy; hypertension; labetalol; methyldopa; pregnancy
2.  Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial 
For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes.
Material and methods
This was a planned, secondary analysis of data from the 987 women in the CHIPS Trial. Logistic regression was used to examine the impact of 19 candidate predictors on the probability of adverse perinatal (pregnancy loss or high level neonatal care for >48 h, or birthweight <10th percentile) or maternal outcomes (severe hypertension, preeclampsia, or delivery at <34 or <37 weeks). A model containing all candidate predictors was used to start the stepwise regression process based on goodness of fit as measured by the Akaike information criterion. For face validity, these variables were forced into the model: treatment group (“less tight” or “tight” control), antihypertensive type at randomization, and blood pressure within 1 week before randomization. Continuous variables were represented continuously or dichotomized based on the smaller p‐value in univariate analyses. An area‐under‐the‐receiver‐operating‐curve (AUC ROC) of ≥0.70 was taken to reflect a potentially useful model.
Point estimates for AUC ROC were <0.70 for all but severe hypertension (0.70, 95% CI 0.67–0.74) and delivery at <34 weeks (0.71, 95% CI 0.66–0.75). Therefore, no model warranted further assessment of performance.
CHIPS data suggest that when women with chronic hypertension develop an elevated blood pressure in pregnancy, or formerly normotensive women develop new gestational hypertension, maternal and current pregnancy clinical characteristics cannot predict adverse outcomes in the index pregnancy.
PMCID: PMC5021204  PMID: 26915709
Preexisting hypertension; chronic hypertension; gestational hypertension; prediction; adverse outcome; maternal; perinatal
3.  The Cost Implications of Less Tight Versus Tight Control of Hypertension in Pregnancy (CHIPS Trial) 
Hypertension (Dallas, Tex. : 1979)  2016;68(4):1049-1055.
Supplemental Digital Content is available in the text.
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.
Clinical Trial Registration—
URL: Unique identifier: NCT01192412.
PMCID: PMC5008043  PMID: 27550914
blood pressure; cost analysis; health policy; hypertension; pregnancy; randomized controlled trials
4.  Childbirth experience questionnaire: validating its use in the United Kingdom 
The Childbirth Experience Questionnaire (CEQ) was developed in Sweden in 2010 and validated in 920 primiparous women. It has not been validated in the United Kingdom (UK).
Measuring the impact of an intervention on a woman’s childbirth experience is arguably as important as measuring its impact on outcomes such as caesarean delivery and perinatal morbidity or mortality and yet surprisingly it is rarely done. The lack of a robust validated tool for evaluating labour experience in the UK is a topical issue in the UK at present. Indeed NICE say ‘A standardised method to measure and quantify women's psychological and emotional wellbeing and their birth experiences is urgently required to support any study investigating the effectiveness of interventions, techniques or strategies during birth.’
The Childbirth Experience Questionnaire and part of the Care Quality Commission Maternity Survey (2010) was sent to 350 women at one month postnatal. The CEQ was sent again two weeks later. The CEQ was tested for face validity among 25 postnatal mothers. Demographic data and delivery data was used to establish construct validity of the CEQ using the method of known-groups validation. The results of the scored CEQ sent out twice were used to measure test-retest reliability of the CEQ by calculating the quadratic weighted index of agreement between the two scores. Criterion validity was measured by calculating the Pearson correlation coefficient for the CEQ and Maternity Survey scores.
Face validity of the CEQ in a UK population was demonstrated with all respondents stating it was easy to understand and complete. A statistically significantly higher CEQ score for subgroups of women known to report a better birth outcome demonstrated construct validity of the CEQ. A weighted kappa of 0.68 demonstrated test-retest reliability of the CEQ. A Pearson correlation co-efficient of 0.73 demonstrated a strong correlation between the results of the CEQ and the results of the ‘gold standard’ assessment of childbirth experience in the UK: the Maternity Survey and hence criterion validity of the CEQ.
The Childbirth Experience Questionnaire is a valid and reliable measure of childbirth experience in the UK population.
PMCID: PMC4396591  PMID: 25884191
Childbirth experience questionnaire; Content validity; Criterion validity; Construct validity; Test-retest reliability; Birth satisfaction
5.  Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial 
There is excess cardiovascular mortality in patients with chronic obstructive pulmonary disease. Aortic stiffness, an independent predictor of cardiovascular risk, and systemic and airway inflammation are increased in patients with the disease. Statins modulate aortic stiffness and have anti-inflammatory properties. A proof-of-principle, double-blind, randomized trial determined if 6 weeks of simvastatin 20 mg once daily reduced aortic stiffness and systemic and airway inflammation in patients with chronic obstructive pulmonary disease.
Stable patients (n=70) were randomized to simvastatin (active) or placebo. Pre-treatment and post-treatment aortic stiffness, blood pressure, spirometry, and circulating and airway inflammatory mediators and lipids were measured. A predefined subgroup analysis was performed where baseline aortic pulse wave velocity (PWV) was >10 m/sec.
Total cholesterol dropped in the active group. There was no significant change in aortic PWV between the active group and the placebo group (−0.7 m/sec, P=0.24). In those with aortic stiffness >10 m/sec (n=22), aortic PWV improved in the active group compared with the placebo group (−2.8 m/sec, P=0.03). Neither systemic nor airway inflammatory markers changed.
There was a nonsignificant improvement in aortic PWV in those taking simvastatin 20 mg compared with placebo, but in those with higher baseline aortic stiffness (a higher risk group) a significant and clinically relevant reduction in PWV was shown.
PMCID: PMC4321645  PMID: 25673981
chronic obstructive pulmonary disease; arterial stiffness; statins
6.  Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT 
Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.
The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.
This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.
Trial registration
Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
PMCID: PMC1933438  PMID: 17623077

Results 1-6 (6)