The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 14 Years to 49 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The ACHIEVE Trial tests whether blood pressure medicine can help pregnancy last longer by lowering blood pressure below 140/90 mmHg. It is for pregnant women who are 23 to nearly 36 weeks along and have a pregnancy-related high blood pressure condition without severe signs.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are pregnant and 23 weeks, 0 days to 35 weeks, 6 days along.
- You have high blood pressure that started during pregnancy or preeclampsia, a pregnancy-related blood pressure condition, without severe signs.
- There is no medical reason to deliver your baby now.
- Your care plan is to continue the pregnancy with monitoring.
- You have one baby or twins with separate outer sacs, as defined at 14 weeks or later. Losing one twin before 14 weeks does not rule you out.
- Your water has not broken.
Who can't join
- You have severe preeclampsia. Signs include blood pressure of 160 or higher on top or 110 or higher on bottom, very low platelets (cells that help blood clot), liver or kidney problems, fluid in the lungs, a new headache that medicine does not help, or vision changes.
- You had kidney problems before 20 weeks, shown by high creatinine (a waste product in blood) or too much protein in your urine.
- You have stage 2 chronic hypertension, a more serious level of long-term high blood pressure.
- You cannot take the study medicines, labetalol and long-acting nifedipine, safely under their FDA label rules.
- You cannot or do not want to follow the care recommendations.
- Your baby's size is below the 10th percentile on an ultrasound done within 3 weeks before joining.
- You have too little fluid around your baby: the deepest fluid pocket is less than 2 cm on an ultrasound done within 48 hours before joining.
- Your baby has a known major problem with body structure or chromosomes, which carry genetic information.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (2)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233Rachel Sinkey · Study contact · 2059345611 · rsinkey@uabmc.eduMore trials in Birmingham
LA
- Oschner · New Orleans, LA 70115Sherri Longo, MD · Study contact · 504-842-4151 · slongo@ochsner.orgMore trials in New Orleans