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New treatment option for Preeclampsia
Official title The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
ClinicalTrials.gov ID: NCT05676476
What this study is testing
What is Antihypertensive treatment?
Antihypertensive treatment is an investigational medicine, being studied as a potential treatment for preeclampsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 49, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other...
- Pulmonary edema
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- New Orleans, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; New Orleans, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.