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Achieve: The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676476
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
132
Enrollment
2
Arms
53
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with preeclampsia will prolong pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antihypertensive treatment
 N/A

Detailed Description

Preeclampsia, a condition characterized by high blood pressure in pregnancy, constitutes a major cause of maternal and perinatal morbidity and mortality; severe hypertension (blood pressure ≥160/110 mmHg) is a common trigger for antihypertensive treatment and preterm delivery. We propose a clinical trial that will test whether lowering the blood pressure in women with preeclampsia at <36 weeks' gestation to <140/90 mmHg will prolong pregnancy and, therefore, improve maternal and fetal/neonatal outcomes. Data generated in this study, along with knowledge and skills acquired by the candidate in the complementary career development plan, will facilitate an independent research career focused on hypertension and cardiovascular disease in pregnancy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Antihypertensive treatment for a BP goal of less than 140/90 mmHg

Drug: Antihypertensive treatment
Antihypertensive treatment to goal of less than 140/90 mmHg
No Intervention: Usual Care

Antihypertensive treatment only if BP ≥ 160/110 mmHg

Outcome Measures

Primary Outcome Measures

  1. Mean number of days from randomization to delivery [From randomization to delivery, up to 14 weeks]

    Duration of prolongation of pregnancy

Secondary Outcome Measures

  1. Perinatal morbidity [6 weeks]

    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.

  2. Neonatal healthcare utilization [6 weeks]

    NICU and hospital length of stay

  3. Maternal morbidity [From randomization to 6 weeks after delivery, up to 20 weeks]

    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.

  4. Maternal healthcare utilization [From randomization to 6 weeks after delivery, up to 20 weeks]

    Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Pregnant women

  • Gestational age: 23 weeks, 0 days to 35 weeks, 6 days

  • 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

  • No indication for delivery at the time of enrollment.

  • Planned expectant management at time of enrollment

  • Singleton gestation - defined as one fetus in utero at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as less than 14 weeks gestation will be eligible.)

  • Dating sonogram at less than 21 weeks of gestation

  • Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation

  • Intact membranes

Exclusion Criteria:

  • Preeclampsia with severe features, defined per ACOG as:

  • 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)

  • Pulmonary edema

  • New-onset headache unresponsive to medication and not accounted for by alternative diagnoses

  • Visual disturbances

  • Underlying renal dysfunction defined as, presenting the following parameters prior to 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Or proteinuria: defined as presenting protein in urine, equal to or higher than, 300 mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urine dipstick reading of greater than or equal to 2 at baseline and in the absence of a urinary tract infection

  • Systemic Lupus erythematosus

  • Labetalol contraindications according to the FDA package insert, which are defined as follows:

+Bronchial asthma, cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia defined as heart rate lower than 60 beats per minute, other conditions associated with severe and prolonged hypotension, pheochromocytoma, patients with a history of hypersensitivity to any component of the product

  • Patient unable to or unwilling to adhere to management recommendations

  • Fetal Reasons for Study Ineligibility:

  • Fetal growth restriction (lower than 10th percentile) at enrollment, based on an ultrasound within 3 weeks prior to enrollment

  • Oligohydramnios defined by amniotic fluid volume lower than 5 cm, based on an ultrasound within the 48 hours prior to enrollment

  • Known major structural or chromosomal abnormality

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Rachel Sinkey, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rachel Sinkey, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05676476
Other Study ID Numbers:
  • 1K23HL159331
  • 1K23HL159331
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pre-Eclampsia
Antihypertensive Agents

Study Results

No Results Posted as of Jan 11, 2023