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

Last updated: December 8, 2024
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Circulation Disorders

Vascular Diseases

Treatment

Antihypertensive treatment

Clinical Study ID

NCT05676476
1K23HL159331
1K23HL159331
  • Ages 14-49
  • Female

Study Summary

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

Inclusion

Inclusion Criteria:

  • Pregnant women

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

  • Hypertensive disorder of pregnancy including gestational hypertension orpreeclampsia, the non-severe form at enrollment, which is called without severefeatures by the American College of Obstetricians and Gynecologists.

  • No evidence of the severe form of preeclampsia, termed severe features, as outlinedin maternal exclusions

  • No indication for delivery at the time of enrollment.

  • Planned expectant management at time of enrollment

  • Singleton or dichorionic twin gestation, defined at and beyond 14 weeks gestation. (A pregnancy complicated by a vanishing twin in the first trimester defined as lessthan 14 weeks gestation will be eligible.)

  • Intact membranes

Exclusion

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 mmHg or more on two occasions at least 4 hours apart (unless antihypertensive therapyis 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 asindicated by abnormally elevated blood concentrations of liver enzymes (to more thantwice the upper limit normal concentrations), or by severe persistent right upperquadrant or epigastric pain unresponsive to medications

  • Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or adoubling of the serum creatinine concentration in the absence of other renaldisease)

  • Pulmonary edema

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

  • Visual disturbances

  • Underlying renal dysfunction defined as, presenting the following parameters priorto 20 weeks gestation: baseline creatinine, equal to or higher than, 1.2 mg/dL Orproteinuria: defined as presenting protein in urine, equal to or higher than, 300mg/24 hours or protein/creatinine ratio, equal to or higher than, 0.3 or Urinedipstick reading of greater than or equal to 2 at baseline and in the absence of aurinary tract infection

  • Stage 2 chronic hypertension

  • Contraindications to labetalol and nifedipine XL according to the FDA package insert

  • 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 anultrasound within 3 weeks prior to enrollment

  • Oligohydramnios defined by amniotic fluid deepest vertical pocket <2 cm based on anultrasound within the 48 hours prior to enrollment

  • Known major structural or chromosomal abnormality

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Antihypertensive treatment
Phase:
Study Start date:
February 14, 2023
Estimated Completion Date:
June 30, 2027

Study Description

Hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, are characterized by new onset high blood pressure in pregnancy and constitute 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 hypertensive disorders of pregnancy 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Oschner

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

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