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The ACHIEVE Trial: Antihypertensive Therapy for Preeclampsia

The ACHIEVE Trial is studying if lowering blood pressure to less than 140/90 mmHg in pregnant women with high blood pressure can help prolong their pregnancy. This study is for women aged 14 to 49 who are pregnant between 23 weeks and 35 weeks and 6 days, and have a hypertensive disorder of pregnancy (high blood pressure during pregnancy) or preeclampsia (a serious condition involving high blood pressure and other symptoms during pregnancy), but not the severe form. The main goal is to see how many days longer pregnancy can be extended from when treatment starts until delivery. The current recruitment status is unclear.

Study design
This is a randomized clinical trial planning to enroll 132 women. It compares standard care with an antihypertensive treatment aiming for blood pressure below 140/90 mmHg.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured from randomization to delivery, up to 14 weeks.

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NCT05676476

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

Recruiting
NAAges 14–49InterventionalTreatment
University of Alabama at Birmingham
~132 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:Antihypertensive treatment

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean number of days from randomization to delivery
Measured over From randomization to delivery, up to 14 weeks

Conditions

Preeclampsia
Gestational Hypertension
Hypertensive Disorder of Pregnancy

Explore related trials

Gestational HypertensionPreeclampsia

Where it's being run

2 sites across 2 states
Alabama1
Louisiana1

Study leadership

  • Rachel Sinkey, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Rachel Sinkey, MD
[email protected]
205-934-5611
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean number of days from randomization to deliveryFrom randomization to delivery, up to 14 weeks

    Duration of prolongation of pregnancy