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The international CHIPS Trial (Control of Hypertension In Pregnancy Study) enrolled 987 women with chronic (75%) or gestational (25%) hypertension. Pre-eclampsia developed in 48%; women remained on their allocated BP control and delivered an average of two weeks later. ‘Less tight’ control (target diastolic BP 100 mmHg) achieved BP that was 6/5mmHg higher (p < 0.001) than ‘tight’ control (target diastolic 85 mmHg, BP achieved 133/85 mmHg). ‘Less tight’ (vs. ‘tight’) control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7%; p = 0.84) that balanced birthweight < 10th percentile (16.1% vs. 19.8%; p = 0.14) against preterm birth (35.6% vs. 31.5%; p = 0.18). 12-month follow-up revealed no compelling evidence for developmental programming of child growth. However, ‘less tight’ (vs. ‘tight’) control resulted in more severe maternal hypertension (40.6% vs. 27.5%; p < 0.001), and more women with platelets < 100 × 109/L (4.3% vs. 1.6%; p = 0.02) or symptomatic elevated liver enzymes (4.3% vs. 1.8%; p = 0.03), with no difference in serious maternal complications (3.7% vs. 2.0%; p = 0.17). Labetalol was the drug of choice. Methyldopa did not result in inferior outcomes. Post-hoc, severe hypertension, independent of pre-eclampsia, was associated with heightened increased risk of adverse outcomes, and in ‘less tight’ control, of serious maternal complications. At no gestational age at initiation of BP control was ‘less tight’ superior to ‘tight’. Women in both groups were equally satisfied with care. ‘Less tight’ control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs. Collectively, CHIPS publications have provided evidence that women with non-severe pregnancy hypertension should receive ‘tight’ BP control achieved by a simple algorithm.

Background It is widely acknowledged that maternal obesity and excessive gestational weight gain (GWG) are associated with increased risk of fetal macrosomia and recent studies have suggested a role for the timing and composition of GWG. Aims To examine the effect of the rate of change in GWG and maternal upper-body subcutaneous fat on neonatal anthropometric outcomes in a pilot observational study amongst women with obesity. Study design Expectant women with a body mass index (BMI) > 30 kg/m2 at first antenatal appointment were recruited at 12 weeks gestation. Maternal height, weight and skinfold thickness (SFT) measurements were collected at baseline and repeated at 28 and 36 weeks gestation. Following delivery, World Health Organisation (WHO)-UK infant birthweight z-scores were calculated, and infant anthropometric measurements were obtained. Results The sum of upper body SFT measurements increased in mid-pregnancy (0.08 ± 0.71 mm/week) and decreased in late pregnancy (−0.04 ± 1.17 mm/week). After adjustment for maternal age, BMI and parity, mid- but not late- pregnancy GWG was positively associated with infant birthweight z-score (p Conclusions The present study suggests that mid- rather than late-pregnancy changes in weight and upper-body subcutaneous fat are associated with infant birthweight. Further research is required in larger, more diverse populations to explore whether pregnancy interventions aiming to improve maternal and offspring health can be personalised beyond BMI and GWG.

Objective: Comparison of birthweight references for diagnosing SGA. To provide denominator data for suspicion and diagnosis of SGA. Design: A retrospective cohort study of 10,616 babies. Setting: A regional obstetric centre. Population: 10,616 consecutive newborns, born in Derriford Hospital, University Hospitals Plymouth NHS Trust (UPHT), whilst using the GROW package,1 compared with using Intergrowth 21st (IG21),2 and British 1990 (UK90) references.3 Methods: Statistical analysis of centile data from GROW, IG21 and UK90 references. Main outcomes: Induction rates, detection of suspected and/or diagnosed SGA. Assessment of goodness of fit to the Plymouth population. Results: GROW and IG21 showed bias. GROW had a systematic bias towards smaller centiles (skewness 0.169). IG21 had a systematic bias towards larger centiles (skewness -0.452). UK90 was best fit to the Plymouth dataset with insignificant bias across centiles (skewness -0.047). Conclusions: GROW and IG21 are not appropriate gold standards for our population for allocation of birthweight centile. The size of the population suggests the conclusions may be extrapolatable to other centres. UK90 does not have everyday accessible tools compared with GROW and IG21. A continual local audit of birthweight would be ideal, enabling accurate local centile allocation. If a national SGA screening programme monitoring units’ ability to detect SGA was introduced, it could not start without validated, unit specific birthweight data. Funding: The statistician’s funding was obtained from UHPT Research and Development generic funding.

We have proposed a long-term, noninvasive, nonrestrictive method of delivering and implanting a biosensor within the body via a swallowable implantation capsule robot (ICR). The design and preliminary validation of the ICR's primary subsystem-the sensor deployment system-is discussed and evidence is provided for major design choices. The purpose of the sensor deployment system is to adhere a small biosensor to the mucosa of the intestine long-term, and the modality was inspired by tapeworms and other organisms that employ a strategy of mechanical adhesion to soft tissue via the combined use of hooks or needles and suckers. Testing was performed to refine the design of the suction and needle attachment as well as the sensor ejection features of the ICR. An experiment was conducted in which needle sharpness, needle length, and vacuum volume were varied, and no statistically significant difference was observed. Finally, preliminary testing, coupled with prior work within a live porcine model, provided evidence that this is a promising approach for implanting a biosensor within the small intestine.

Objective 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. Design Secondary analysis of CHIPS Trial cohort. Setting International randomised controlled trial (94 sites, 15 countries). Population or sample 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. Methods Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors. Main outcome measures CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight

Background/objectives: Short sleep duration has been linked to maternal hyperglycaemia following a 1-h 50 g oral glucose tolerance test (OGTT) in observational studies conducted primarily in the USA. Our objective was to examine the relationship between objectively measured sleep duration and plasma glucose values following the 2-h 75 g OGTT routinely used in the UK amongst women with obesity. Methods Sleep and OGTT data were available for 49 pregnant women who wore wrist actigraphs for at least two nights, and took a 2-h 75 g OGTT at the end of their second trimester. Multivariable regression was used to evaluate associations between sleep duration and OGTT results. Results Higher 2-h plasma glucose values were significantly associated with shorter sleep duration and higher maternal age and BMI, with no association observed between wake after sleep onset (WASO) and 2-h plasma glucose values. No associations were observed between fasting plasma glucose values and any sleep parameters. Conclusions We found that shorter sleep duration, as measured using actigraphy, is associated with higher 2-h plasma glucose values following a 2-h 75 g OGTT in the UK. These findings are in keeping with those observed elsewhere in the world, employing alternative OGTT protocols. Future studies should investigate sleep extension as a potential candidate for inclusion in future RCTs aiming to improve glucose tolerance and prevent GDM amongst those at risk.

For hypertensive women in CHIPS (Control of Hypertension in Pregnancy Study), we assessed whether the maternal benefits of tight control could be achieved, while minimizing any potentially negative effect on fetal growth, by delaying initiation of antihypertensive therapy until later in pregnancy. For the 981 women with nonsevere, chronic or gestational hypertension randomized to less-tight (target diastolic blood pressure, 100 mm Hg), or tight (target, 85 mm Hg) control, we used mixed-effects logistic regression to examine whether the effect of less-tight (versus tight) control on major outcomes was dependent on gestational age at randomization, adjusting for baseline factors as in the primary analysis and including an interaction term between gestational age at randomization and treatment allocation. Gestational age was considered categorically (quartiles) and continuously (linear or quadratic form), and the optimal functional form selected to provide the best fit to the data based on the Akaike information criterion. Randomization before (but not after) 24 weeks to less-tight (versus tight) control was associated with fewer babies with birth weight P interaction =0.005), but more preterm birth ( P interaction =0.043), and no effect on perinatal death or high-level neonatal care >48 hours ( P interaction =0.354). For the mother, less-tight (versus tight) control was associated with more severe hypertension at all gestational ages but particularly so before 28 weeks ( P interaction =0.076). In women with nonsevere, chronic, or gestational hypertension, there seems to be no gestational age at which less-tight (versus tight) control is the preferred management strategy to optimize maternal or perinatal outcomes. Clinical Trial Registration— URL: https://www.isrctn.com . Unique identifier: ISRCTN71416914.

BACKGROUND\ud The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear.\ud METHODS\ud We performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later.\ud RESULTS\ud Included in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (P

Colonoscopy is a diagnostic procedure to detect pre-cancerous polyps and tumours in the colon, and is performed by inserting a long tube equipped with a camera and biopsy tools. Despite the medical benefits, patients undergoing this procedure often complain about the associated pain and discomfort. This discomfort is mostly due to the rough handling of the tube and the creation of loops during the insertion. The overall goal of this work is to minimise the invasiveness of traditional colonoscopy. In pursuit of this goal, this work presents the development of a semi-autonomous colonoscopic robot with minimally invasive locomotion. The proposed robotic approach allows physicians to concentrate mainly on the diagnosis rather than the mechanics of the procedure. In this paper, an innovative locomotion approach for robotic colonoscopy is addressed. Our locomotion approach takes advantage of longitudinal expansion of a latex tube to propel the robot's tip along the colon. This soft and compliant propulsion mechanism, in contrast to minimally invasive mechanisms used in, for example, inchworm-like robots, has shown promising potential. In the preliminary ex vivo experiments, the robot successfully advanced 1.5 metres inside an excised curvilinear porcine colon with average speed of 28 mm/s, and was capable of traversing bends up to 150 degrees. The robot creates less than 6 N of normal force at its tip when it is pressurised with 90 kPa. This maximum force generates pressure of 44.17 mmHg at the tip, which is significantly lower than safe intraluminal human colonic pressure of 80 mmHg. The robot design inherently prevents loop formation in the colon, which is recognised as the main cause of post procedural pain in patients. Overall, the robot has shown great promise in an ex vivo experimental setup. The design of an autonomous control system and in vivo experiments are left as future work.

We describe a semi-autonomous tracking technique based on a Bayesian prediction mechanism for a pneumatic colonoscopy robot. One of the principal problems in using a robot colonoscope is to determine its position or displacement after it has been inserted into the colon. To address this problem for our robot, we have developed a temporal Bayesian framework that uses the observations of the air flow rate and pressure in the tube guiding the robot to predict the current location of the robot. Our experimental results show that the predicted location and velocity of the robot are accurate over most of the time-steps, with a maximum error of 11.5 cm (about 2.5 times the length of the robot’s head) occurring only \(7\%\) of the time.

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 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 P 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 preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome ( P P =0.005), delivery at P P 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: http://pre-empt.cfri.ca/ . Unique identifier: ISRCTN 71416914. URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT01192412.

Objective: To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412). Design: Quantitative and qualitative analysis of questionnaire responses. Setting: International randomised trial (94 sites, 15 countries). Population/sample: 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85 mmHg) or 'less tight' (target diastolic blood pressure, 100 mmHg) who completed questionnaires. Methods: A questionnaire was administered at similar to 6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site coordinator, 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

Introduction 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

BACKGROUND Noninvasive genotyping of fetal RHD (Rh blood group, D antigen) can prevent the unnecessary administration of prophylactic anti-D to women carrying RHD-negative fetuses. We evaluated laboratory methods for such genotyping. METHODS Blood samples were collected in EDTA tubes and Streck® Cell-Free DNA™ blood collection tubes (Streck BCTs) from RHD-negative women (n = 46). Using Y-specific and RHD-specific targets, we investigated variation in the cell-free fetal DNA (cffDNA) fraction and determined the sensitivity achieved for optimal and suboptimal samples with a novel Droplet Digital™ PCR (ddPCR) platform compared with real-time quantitative PCR (qPCR). RESULTS The cffDNA fraction was significantly larger for samples collected in Streck BCTs compared with samples collected in EDTA tubes (P < 0.001). In samples expressing optimal cffDNA fractions (≥4%), both qPCR and digital PCR (dPCR) showed 100% sensitivity for the TSPY1 (testis-specific protein, Y-linked 1) and RHD7 (RHD exon 7) assays. Although dPCR also had 100% sensitivity for RHD5 (RHD exon 5), qPCR had reduced sensitivity (83%) for this target. For samples expressing suboptimal cffDNA fractions ( CONCLUSIONS qPCR was not found to be an effective tool for RHD genotyping in suboptimal samples (

Twenty elite early-maturing (75−90 days) tropical maize varieties grown in three diverse agroecologies in West Africa were evaluated to identify varieties with high kernel-Fe and -Zn and bioavailable Fe levels. Bioavailable iron was assessed using an in vitro digestion/Caco-2 cell model. Significant (P < 0.001) varietal differences were observed in mean kernel-Fe and -Zn levels. The ranges were 15.5−19.1 mg kg-1 for Fe and 16.5−20.5 mg kg-1 for Zn. Genetic component accounted for 34% of the total variation in kernel-Zn and for 11% of the variation in kernel-Fe levels. Mean bioavailable Fe in varieties ranged between 4% below and 49% above the reference control variety. A significant negative relationship was detected between kernel-P concentration and bioavailable Fe (R = −0.36; P < 0.004; n = 60). Two varieties, ACR90POOL16-DT and ACR86TZESR-W, were identified as the most promising for further evaluation to determine their efficacy as improved sources of iron in target populations. Keywords: Iron biofort...

Objectives The CHIPS Trial (ISRCTN 71416914, http://pre-empt.cfri.ca/CHIPS ) randomized women with non-severe pregnancy hypertension to a diastolic blood pressure (dBP) target of 100 mmHg [‘less tight’ (LT) control] vs. 85 mmHg [‘tight’ (T) control]. LT was associated with no perinatal benefit, but more severe maternal hypertension. Labetalol was the recommended post-randomization antihypertensive. We aimed to: (1) determine whether the difference in outcomes between LT vs. T control depended on antihypertensive used; and (2) compare pregnancy outcomes, taking into account allocated group, between women taking methyldopa and those taking labetalol, the two most commonly used antihypertensives in CHIPS. Methods Logistic regression was used for comparisons outlined in objectives (1) and (2). Both analyses adjusted for the influence of baseline factors, including use of any antihypertensive therapy at randomization. Results Of 987 women in CHIPS, labetalol (but not methyldopa) was taken by 433/837 women on antihypertensive therapy [186 (LT) vs. 247 (T)] and methyldopa (but not labetalol) by 223/837 [98 (LT) vs. 125 (T)]. Following adjustment: (1) ORs for outcomes in LT vs. T control were similar between antihypertensive groups, but (2) methyldopa use was associated with a reduction in some outcomes (Table). Additional sensitivity analyses had a trivial impact on results. Conclusions In this secondary analysis of CHIPS data, outcomes for LT vs. T control were not dependent on use of methyldopa or labetalol. The non-randomized comparisons between methyldopa and labetalol are subject to residual confounding, but there is no evidence that women treated with methyldopa (vs. labetalol) had inferior outcomes. Disclosures L.A. Magee: Research Support Recipient; Commercial Interest: BMGF. P. von Dadelszen: Consultant, Commercial Interest: Alere International. E. Rey: None. S. Ross: None. E. Asztalos: None. K.E. Murphy: None. J. Menzies: None. J. Sanchez: None. J. Singer: None. A. Gafni: None. A. Gruslin: None. M. Helewa: None. E. Hutton: None. S.K. Lee: None. A.G. Logan: None. W. Ganzevoort: None. R. Welch: None. J.G. Thornton: None. J. Moutquin: None.

OBJECTIVE: Our purpose was to describe the clinical utility of a deoxyribonucleic acid amplification method for determining fetal RhD status in alloimmunized pregnancies STUDY DESIGN: Six RhD-negative women with alloimmunized pregnancies and heterozygous partners underwent amniocentesis ( n = 5) or chorionic villus sampling ( n = 1). Fetal RhD type was determined by polymerase chain reaction and results disclosed to the attending physicians. RESULTS: Knowledge of the fetal RhD status avoided further invasive procedures in two pregnancies and facilitated the timing or performance of intrauterine transfusions in the remainder. CONCLUSIONS: In alloimmunized pregnancies the ability to RhD-type the fetus in amniotic fluid avoids the risks of fetomaternal. hemorrhage and increased sensitization associated with fetal blood sampling or chorionic biopsy. This allows more rational pregnancy management, avoiding invasive procedures in the presence of an RhD-negative fetus, or planning therapeutic interventions or offering termination of pregnancy in the presence of an RhD-positive fetus.

OBJECTIVE: Our aim was to determine the changes in fetal hemorheologic parameters caused by fetal intravascular transfusion for alloimmune anemia. STUDY DESIGN: Fetal blood samples were collected before and after 95 fetal transfusions in 31 women. Fetal hematocrit, whole-blood viscosity at a variety of shear rates, plasma viscosity, fetal fibrinogen, and fetal plasma proteins were measured. RESULTS: Fetal whole-blood viscosity increased, sometimes massively, with transfusion. The rise in viscosity was principally dependent on the rise in hematocrit, with a linear rise in hematocrit producing a linear rise in the logarithm of whole-blood viscosity, but was also affected by the amount of adult plasma proteins present in the donor blood. CONCLUSIONS: Rises in fetal whole-blood viscosity during transfusion can be minimized by using donor blood that has been serum depleted to a high hematocrit (>90%) and by restricting the end hematocrit to 50% to 55%. (AM J OBSTET GYNECOL 1994;170:726-32.)

Objectives Normalizing blood pressure in pregnancy may reduce maternal complications but increase adverse perinatal effects. CHIPS aimed to determine whether a higher (vs. lower) blood pressure target improves perinatal outcome, without compromising maternal safety in non-severe pregnancy hypertension. Methods In an open pragmatic international multicenter trial, women at 14 + 0 − 33 + 6 weeks gestation with non-proteinuric pre-existing or gestational hypertension, office diastolic BP (dBP) 90–105 mmHg (or 85–105 mmHg if on antihypertensives) and a live fetus were randomized to ‘less tight’ (target dBP 100 mmHg) or ‘tight’ control (target dBP 85 mmHg). The composite primary outcome was pregnancy loss or high level neonatal care for >48 h in the first 28 d of life, and the secondary, serious maternal complications before 6 weeks postpartum. Outcomes were compared between groups using logistic regression adjusted for key prognostic factors. Results Of 1030 women randomized, 987 (94 sites) were included in the analysis. 74.6% had pre-existing hypertension. Women in ‘less tight’ ( n = 497) compared with ‘tight’ ( n = 490) control had similar rates of adverse perinatal (31.4% vs. 30.7%; aOR 1.02 [0.77, 1.35]) and maternal outcomes (3.7% vs. 2.0%; aOR 1.74 [0.79, 3.84]), despite higher mean dBP by 4.6 mmHg (95% confidence interval 3.7, 5.4). Severe hypertension (⩾160/110 mmHg) developed more frequently in ‘less tight’ (vs. ‘tight’) control (40.6% vs. 27.5%; aOR 1.80 [1.36, 2.38]). Conclusions ‘Less tight’ (vs. ‘tight’) control did not improve perinatal outcome, but did result in more severe hypertension. Our results do not support ‘less tight’ control of non-severe pregnancy hypertension. Disclosures L.A. Magee: Research Support Recipient; Commercial Interest(s): BMGF. P. von Dadelszen: Consultant; Commercial Interest: Alere International; Research Support Recipient; Commercial Interest: BMGF. E. Rey: None. S. Ross: None. E. Asztalos: None. K.E. Murphy: None. J. Menzies: None. J. Sanchez: None. J. Singer: None. A. Gafni: None. A. Gruslin: None. M. Helewa: None. E. Hutton: None. S.K. Lee: None. A.G. Logan: None. W. Ganzevoort: None. R. Welch: None. J.G. Thornton: None. J. Moutquin: None. T. Study Group: None.

Madam, I feel that a recent article Termination of pregnancy: Why are live births occuring? (Drazek, (1999) M Br J Midwifery 7 (12) 742–4) should not go unanswered.