ORCID Profile
0000-0002-6213-0682
Current Organisations
Aarhus University
,
Aarhus Universitet Business and Social Sciences
,
Canterbury Christ Church University
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Publisher: Journal of Business Models
Date: 2021
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2021
DOI: 10.1161/HYPERTENSIONAHA.121.17171
Abstract: This study evaluated whether planned early delivery would ameliorate cardiovascular dysfunction 6 months postpartum, compared with usual care with expectant management, in women with late preterm preecl sia. We conducted a mechanistic observational study in women with preterm preecl sia between 34 +0 and 36 +6 weeks’ gestation, nested within a randomized controlled trial of planned early delivery versus expectant management (usual care), in 28 maternity hospitals in England and Wales. Women were followed up 6 months postpartum with cardiovascular assessments. The primary outcome was a composite of systolic and diastolic dysfunction (by 2009 and 2016 definitions of diastolic dysfunction). Between April 27, 2016, and November 30, 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited. One hundred thirty-three women were randomized to planned delivery, 137 women were randomized to expectant management within the trial, while 150 women received expectant management outside of the trial. 321 (76.4%) completed their 6 month echocardiography assessment. 10% (31/321) had a left ventricular ejection fraction % while 71% (229/321) remained hypertensive. There were no differences in the primary outcome between the 2 randomized groups (planned delivery versus expectant management) using either the 2009 (risk ratio, 1.06 [95% CI, 0.80–1.40]) or 2016 definitions (risk ratio, 0.78 [0.33–1.86]). In conclusion, we demonstrated that late preterm preecl sia results in persistence of hypertension in the majority and systolic LV dysfunction in 10%, of women 6 months postpartum. Planned early delivery does not affect these outcomes. Preecl sia is not a self-limiting disease of pregnancy alone.
Publisher: National Institute for Health and Care Research
Date: 09-2021
DOI: 10.3310/EME08120
Abstract: Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-ecl sia, are at increased risk of long-term cardiovascular morbidity and mortality. To investigate the hypothesis that prolongation of a pregnancy affected by preterm pre-ecl sia managed by expectant management compared with planned early delivery would result in worse cardiovascular function 6 months postpartum. A randomised controlled trial. 28 maternity hospitals in England and Wales. Women who were eligible for the Pre-ecl sia in HOspital: Early iNductIon or eXpectant management (PHOENIX) study were approached and recruited for the PHOEBE study. The PHOENIX (Pre-ecl sia in HOspital: Early iNductIon or eXpectant management) study was a parallel-group, non-masked, multicentre, randomised controlled trial that was carried out in 46 maternity units across England and Wales. This study compared planned early delivery with expectant management (usual care) with in idual randomisation in women with late preterm pre-ecl sia who were 34 weeks’ gestation to less than 37 weeks’ gestation and having a singleton or dichorionic diamniotic twin pregnancy. Postpartum follow-up included medical history, blood pressure assessment and echocardiography. All women had blood s ling performed on at least two time points from recruitment to the 6-month follow-up for assessment of cardiac necrosis markers. Primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines then updated by 2016 guidelines, with an amended definition of diastolic dysfunction). Analyses were by intention to treat, together with a per-protocol analysis for the primary and secondary outcomes. Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited across 28 maternity units in England and Wales. A total of 133 women were allocated to planned delivery, 137 women were allocated to expectant management and a further 150 received non-randomised expectant management within usual care. The mean time from enrolment to delivery was 2.5 (standard deviation 1.9) days in the planned delivery group compared with 6.8 (standard deviation 5.3) days in the expectant management group. There were no differences in the primary outcome between women in the planned delivery group and those in the expectant management group using either the 2009 (risk ratio 1.06, 95% confidence interval 0.80 to 1.40) or the 2016 definition (risk ratio 0.78, 95% confidence interval 0.33 to 1.86). Overall, 10% (31/321) of women had a left ventricular ejection fraction 55% and 71% of the cohort remained hypertensive at 6 months postpartum. No differences were observed between groups in cardiorespiratory outcomes prior to discharge from hospital or in systolic or diastolic blood pressure measurements. Variables associated with the primary outcome (2009 definition) at 6 months postpartum were maternal body mass index (adjusted odds ratio 1.33 per 5 kg/m 2 , 95% confidence interval 1.12 to 1.59 per 5 kg/m 2 ) and maternal age (adjusted odds ratio 2.16, 95% confidence interval 1.44 to 3.22 per 10 years). Limitations include changing definitions regarding systolic and/or diastolic dysfunction. Preterm pre-ecl sia results in persistence of hypertension in the majority of women with late preterm pre-ecl sia at 6 months postpartum and systolic dysfunction in 10%. Pre-ecl sia should not be considered a self-limiting disease of pregnancy alone. Interventions aimed at reducing cardiovascular dysfunction. Current Controlled Trials ISRCTN01879376. 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. 8, No. 12. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 11-2022
DOI: 10.3310/CWWH0622
Abstract: In women with late preterm pre-ecl sia (i.e. at 34 +0 to 36 +6 weeks’ gestation), the optimal delivery time is unclear because limitation of maternal–fetal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether or not planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of perinatal or infant outcomes, compared with expectant management, in women with late preterm pre-ecl sia. We undertook an in idually randomised, triple non-masked controlled trial in 46 maternity units across England and Wales, with an embedded health economic evaluation, comparing planned delivery and expectant management (usual care) in women with late preterm pre-ecl sia. The co-primary maternal outcome was a maternal morbidity composite or recorded systolic blood pressure of ≥ 160 mmHg (superiority hypothesis). The co-primary short-term perinatal outcome was a composite of perinatal deaths or neonatal unit admission (non-inferiority hypothesis). Analyses were by intention to treat, with an additional per-protocol analysis for the perinatal outcome. The primary 2-year infant neurodevelopmental outcome was measured using the PARCA-R (Parent Report of Children’s Abilities-Revised) composite score. The planned s le size of the trial was 900 women the trial is now completed. We undertook two linked substudies. Between 29 September 2014 and 10 December 2018, 901 women were recruited 450 women [448 women (two withdrew consent) and 471 infants] were allocated to planned delivery and 451 women (451 women and 475 infants) were allocated to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group [289 (65%) women] than in the expectant management group [338 (75%) women] (adjusted relative risk 0.86, 95% confidence interval 0.79 to 0.94 p = 0.0005). The incidence of the co-primary perinatal outcome was significantly higher in the planned delivery group [196 (42%) infants] than in the expectant management group [159 (34%) infants] (adjusted relative risk 1.26, 95% confidence interval 1.08 to 1.47 p = 0.0034), but indicators of neonatal morbidity were similar in both groups. At 2-year follow-up, the mean PARCA-R scores were 89.5 points (standard deviation 18.2 points) for the planned delivery group (290 infants) and 91.9 points (standard deviation 18.4 points) for the expectant management group (256 infants), both within the normal developmental range (adjusted mean difference –2.4 points, 95% confidence interval –5.4 to 0.5 points non-inferiority p = 0.147). Planned delivery was significantly cost-saving (–£2711, 95% confidence interval –£4840 to –£637) compared with expectant management. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. In women with late preterm pre-ecl sia, planned delivery reduces short-term maternal morbidity compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater short-term neonatal morbidity (such as need for respiratory support). At 2-year follow-up, around 60% of parents reported follow-up scores. Average infant development was within the normal range for both groups the small between-group mean difference in PARCA-R scores is unlikely to be clinically important. Planned delivery was significantly cost-saving to the health service. These findings should be discussed with women with late preterm pre-ecl sia to allow shared decision-making on timing of delivery. Limitations of the trial include the challenges of finding a perinatal outcome that adequately represented the potential risks of both groups and a maternal outcome that reflects the multiorgan manifestations of pre-ecl sia. The incidences of maternal and perinatal primary outcomes were higher than anticipated on the basis of previous studies, but this did not limit interpretation of the analysis. The trial was limited by a higher loss to follow-up rate than expected, meaning that the extent and direction of bias in outcomes (between responders and non-responders) is uncertain. A longer follow-up period (e.g. up to 5 years) would have enabled us to provide further evidence on long-term infant outcomes, but this runs the risk of greater attrition and increased expense. We identified a number of further questions that could be prioritised through a formal scoping process, including uncertainties around disease-modifying interventions, prognostic factors, longer-term follow-up, the perspectives of women and their families, meta-analysis with other studies, effect of a similar intervention in other health-care settings, and clinical effectiveness and cost-effectiveness of other related policies around neonatal unit admission in late preterm birth. The trial was prospectively registered as ISRCTN01879376. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in Health Technology Assessment . See the NIHR Journals Library website for further project information.
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Annabeth Aagaard.