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

The University of Alabama at Birmingham

Status

Enrolling

Conditions

Preeclampsia

Gestational Hypertension

Hypertensive Disorder of Pregnancy

Treatments

Drug: Antihypertensive treatment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05676476

1K23HL159331 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 estimated patients

Sex

Female

Ages

14 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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 less than 14 weeks gestation will be eligible.)
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
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 an ultrasound within 3 weeks prior to enrollment
Oligohydramnios defined by amniotic fluid deepest vertical pocket <2 cm based on an ultrasound within the 48 hours prior to enrollment
Known major structural or chromosomal abnormality