URL: http://www.clinicaltrials.gov. Unique identifier: NCT02333240.
Objective To develop a core outcome set for pre-eclampsia. Design Consensus development study. Setting International. Population Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods Modified Delphi method and Modified Nominal Group Technique. Results A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting.
Women with hypertensive pregnancies are 4× more likely to develop chronic hypertension. Previously, we showed a short period of blood pressure (BP) self-management following hypertensive pregnancy resulted in persistently lower BP after 6 months. We now report the impact on long-term BP control. Women who participated in the postpartum randomized controlled trial, SNAP-HT (Self-Management of Postnatal Hypertension; NCT02333240), were invited for 24-hour ambulatory and clinic BP measures. Height and weight were measured by calibrated scales and standardized tape measures, activity by 7-day wrist-worn accelerometer, and dietary factors assessed by questionnaire. Sixty-one of 70 eligible women were followed up 3.6±0.4 years after their original pregnancy. Twenty-four–hour diastolic BP was 7.0 mm Hg lower in those originally randomized to postpartum BP self-management instead of usual care. This difference remained significant after adjustment for either BP at the time of delivery (−7.4 mm Hg [95% CI, −10.7 to −4.2]; P <0.001) or pregnancy booking BP (−6.9 mm Hg [95% CI, −10.3 to −3.6]; P <0.001). Adjustment for current salt intake, age, body mass index, waist-to-hip ratio, arm circumference, parity, alcohol intake, and physical activity had no effect on this difference. Reductions in diastolic BP at 6 months, following self-management of BP postpartum, are maintained 3.6 years later as measured by lower 24-hour diastolic BP. Interventions to optimize BP control during the puerperium in women with hypertensive pregnancies improve BP in the longer term, in a cohort at increased risk of developing chronic hypertension and major adverse cardiovascular events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02333240.
ObjectivesHypertensive disorders of pregnancy (HDP) affect one in ten pregnancies and often persist postpartum when complications can occur. We aimed to determine the effectiveness and safety of pharmacological interventions, other interventions and different care models for postpartum hypertension management.DesignA systematic review was undertaken. Nine electronic databases, including Medline, were searched from inception to 16 March 2017. After duplicate removal, 4561 records were screened. Two authors independently selected studies, extracted study characteristics and data, and assessed methodological quality.SettingRandomised controlled trials, case–control studies and cohort studies from any country and healthcare setting.ParticipantsPostnatal women with HDP.InterventionsTherapeutic intervention for management of hypertension, compared with another intervention, placebo or no intervention.Primary and secondary outcome measuresOutcome data were collected for maternal mortality and severe morbidity; systolic, diastolic and mean arterial blood pressure (BP) control; and safety data. Secondary outcome data collected included the length of postnatal hospital stay and laboratory values.Results39 studies were included (n=2901). Results were heterogeneous in terms of intervention, comparison and outcome requiring a narrative approach. There were insufficient data to recommend any single pharmacological intervention. 18 studies reported calcium-channel blockers, vasodilators and beta-blockers lowered BP postpartum. 12 of these reported safety data. Limited data existed regarding management in the weeks following hospital discharge. Neither loop diuretics (three studies) nor corticosteroids (one study) produced clinical benefit. Uterine curettage significantly reduced BP over the first 48 hours postpartum (range 6–13 mm Hg) compared with standard care (eight studies), with safety data only reported by four of eight studies.ConclusionThere was insufficient evidence to recommend a particular BP threshold, agent or model of care, but three classes of antihypertensive appeared variably effective. Further comparative research, including robust safety data, is required. Curettage reduced BP, but without adequate reporting of harms, so it cannot currently be recommended.
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