The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-49
SponsorUniversity of Alabama at Birmingham
About this trial
The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong pregnancy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women
Gestational age: 23 weeks, 0 days to 35 weeks, 6 days
Hypertensive disorder of pregnancy including gestational hypertension or preeclampsia, the non-severe form at enrollment, which is called without severe features by the American College of Obstetricians and Gynecologists.
No evidence of the severe form of preeclampsia, termed severe features, as outlined in maternal exclusions
Disqualifiers
Systolic blood pressure of 160 mm Hg or more, or diastolic blood pressure of 110 mm Hg or more on two occasions at least 4 hours apart (unless antihypertensive therapy is initiated before this time)
Thrombocytopenia defined as: lower than 100 x 10e9 platelets/L
Impaired liver function that is not accounted for by alternative diagnoses and as indicated by abnormally elevated blood concentrations of liver enzymes (to more than twice the upper limit normal concentrations), or by severe persistent right upper quadrant or epigastric pain unresponsive to medications
Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease)
Trial design
Design model
Parallel
Treatments tested in this trial
Antihypertensive treatment
DrugAntihypertensive treatment to goal of less than 140/90 mmHg
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean number of days from randomization to delivery
Duration of prolongation of pregnancy
Time frame
From randomization to delivery, up to 14 weeksSecondary outcomes
1
Perinatal morbidity
Composite of NICU admission ≥2 days, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, or fetal or newborn death within 6 weeks after birth; individual elements of the composite, the frequency of small for gestational age neonates, birthweight.
Time frame
6 weeks2
Neonatal healthcare utilization
NICU and hospital length of stay
Time frame
6 weeks3
Maternal morbidity
Composite of severe hypertension, pulmonary edema, heart failure, eclampsia, stroke, liver dysfunction, acute renal failure, thrombocytopenia, abruption, ICU admission, postpartum hospital readmission for hypertension management, or death within 6 weeks of delivery; individual elements of the composite.
Time frame
From randomization to 6 weeks after delivery, up to 20 weeks4
Maternal healthcare utilization
Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.
Time frame
From randomization to 6 weeks after delivery, up to 20 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov