Actively Recruiting

Phase Not Applicable
Age: 14Years - 49Years
FEMALE
ID05676476

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

Led by University of Alabama at Birmingham · Updated on 2025-12-12

132

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy, such as gestational hypertension and preeclampsia, can help prolong pregnancy. These conditions, marked by new high blood pressure during pregnancy, often lead to early delivery due to severe hypertension. The study intends to improve outcomes for mothers and babies by testing if stricter blood pressure control delays delivery before 36 weeks of gestation. Participants are randomly assigned to one of two groups: one receiving antihypertensive treatment aimed at keeping blood pressure below 140/90 mmHg, and the other receiving treatment only if blood pressure reaches 160/110 mmHg or higher. The trial includes women with non-severe hypertensive disorders of pregnancy and plans expectant management without immediate delivery. The study covers patients with singleton or twin pregnancies beyond 14 weeks gestation. Throughout the study, researchers will monitor participants from the time of randomization until delivery, measuring the average days of pregnancy prolongation up to 14 weeks. They will also assess maternal and perinatal health outcomes up to six weeks postpartum, including healthcare use and complications. The total participation time varies depending on delivery timing, with follow-up continuing up to 20 weeks after delivery for some measures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years - 49Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women
  • Gestational age between 23 weeks, 0 days and 35 weeks, 6 days
  • Diagnosed with hypertensive disorder of pregnancy including gestational hypertension or preeclampsia without severe features
  • No indication for delivery at enrollment
  • Planned expectant management at enrollment
  • Singleton or dichorionic twin pregnancy at or beyond 14 weeks gestation
  • Intact membranes
Not Eligible

You will not qualify if you...

  • Preeclampsia with severe features (systolic BP ≥160 mm Hg or diastolic BP ≥110 mm Hg on two occasions at least 4 hours apart unless treatment started earlier)
  • Thrombocytopenia (platelets lower than 100 x 10e9/L)
  • Impaired liver function with elevated liver enzymes or severe persistent pain
  • Renal insufficiency (serum creatinine >1.1 mg/dL or doubling without other kidney disease)
  • Pulmonary edema
  • New headache unresponsive to medication
  • Visual disturbances
  • Underlying renal dysfunction before 20 weeks gestation (high creatinine or proteinuria)
  • Stage 2 chronic hypertension
  • Contraindications to labetalol or nifedipine XL
  • Unable or unwilling to follow management recommendations
  • Fetal growth restriction below 10th percentile
  • Oligohydramnios (amniotic fluid pocket <2 cm within 48 hours)
  • Known major fetal structural or chromosomal abnormalities

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 14 weeks or until delivery

Participants receive antihypertensive treatment to lower blood pressure to below 140/90 mmHg or usual care depending on their assigned group, from randomization until delivery.

Regular visits as per clinical management

Follow-up

Duration - Up to 6 weeks post-delivery

Participants are monitored for maternal and neonatal outcomes after delivery for up to 6 weeks.

Approximately 1 to 2 visits post-delivery

Trial Site Locations

Total: 2 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Oschner

New Orleans, Louisiana, United States, 70115

Actively Recruiting

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Research Team

R

Rachel Sinkey, MD

A

Alan Tita, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

George S Stergiou, Bruce Alpert, Stephan Mieke...

https://pubmed.ncbi.nlm.nih.gov/29384983

Prevention, Diagnosis, and Management of Hypertensive Disorders of Pregnancy: a Comparison of International Guidelines.

Rachel G Sinkey, Ashley N Battarbee, Natalie A Bello...

https://pubmed.ncbi.nlm.nih.gov/32852691

Accuracy of Blood Pressure Measurement Devices in Pregnancy: A Systematic Review of Validation Studies.

Natalie A Bello, Jonathan J Woolley, Kirsten Lawrence Cleary...

https://pubmed.ncbi.nlm.nih.gov/29229741