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

November 12, 2023 updated by: Rachel Sinkey, University of Alabama at Birmingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.)
  • Dating sonogram at less than 21 weeks of gestation
  • Prenatal care, or another healthcare visit with a documented blood pressure, at less than 21 weeks gestation
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Antihypertensive treatment for a BP goal of less than 140/90 mmHg
Drug: Antihypertensive treatment
Antihypertensive treatment to goal of less than 140/90 mmHg
No Intervention: Usual Care
Antihypertensive treatment only if BP ≥ 160/110 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of days from randomization to delivery
Time Frame: From randomization to delivery, up to 14 weeks
Duration of prolongation of pregnancy
From randomization to delivery, up to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal morbidity
Time Frame: 6 weeks
Composite of NICU admission ≥2 days, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, or fetal or newborn death within 6 weeks after birth; individual elements of the composite, the frequency of small for gestational age neonates, birthweight.
6 weeks
Neonatal healthcare utilization
Time Frame: 6 weeks
NICU and hospital length of stay
6 weeks
Maternal morbidity
Time Frame: From randomization to 6 weeks after delivery, up to 20 weeks
Composite of severe hypertension, pulmonary edema, heart failure, eclampsia, stroke, liver dysfunction, acute renal failure, thrombocytopenia, abruption, ICU admission, postpartum hospital readmission for hypertension management, or death within 6 weeks of delivery; individual elements of the composite.
From randomization to 6 weeks after delivery, up to 20 weeks
Maternal healthcare utilization
Time Frame: From randomization to 6 weeks after delivery, up to 20 weeks
Antepartum and postpartum hospital length of stay, ICU admission, postpartum readmission.
From randomization to 6 weeks after delivery, up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Rachel Sinkey, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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