Recruiting

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

Sponsor:

University of Alabama at Birmingham

Code:

NCT05676476

Conditions

Preeclampsia

Gestational Hypertension

Hypertensive Disorder of Pregnancy

Eligibility Criteria

Sex: Female

Age: 14 - 49

Healthy Volunteers: Not accepted

Interventions

Antihypertensive treatment

Study Details

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 hypertensive disorders of pregnancy will prolong pregnancy.

Conditions

Preeclampsia

Gestational Hypertension

Hypertensive Disorder of Pregnancy

Study ID

NCT05676476

Start date

Feb 14, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 14 - 49

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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

no intervention: Usual Care

Antihypertensive treatment only if BP ≥ 160/110 mmHg

Interventions

Antihypertensive treatment

Antihypertensive treatment to goal of less than 140/90 mmHg

Primary outcome measure

Mean number of days from randomization to delivery [ Time Frame: From randomization to delivery, up to 14 weeks ]

Central Contacts and Locations

Central contacts

Rachel Sinkey, MD

205-934-5611 rsinkey@uabmc.edu

Alan Tita, MD

205-934-5611 atita@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Rachel Sinkey

2059345611 rsinkey@uabmc.edu

Oschner

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Sherri Longo, MD

504-842-4151 slongo@ochsner.org

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-12.