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Antihypertensive
Antihypertensive Therapy for Preeclampsia (Achieve Trial)
N/A
Recruiting
Led By Rachel Sinkey, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hypertensive disorder of pregnancy including gestational hypertension or non-severe preeclampsia at enrollment
Pregnant women with gestational age between 23 weeks, 0 days and 35 weeks, 6 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 6 weeks after delivery, up to 20 weeks
Awards & highlights
Achieve Trial Summary
This trial will test if lowering BP in pregnant women with preeclampsia can help them carry their baby longer.
Who is the study for?
The ACHIEVE Trial is for pregnant women with high blood pressure disorders, including gestational hypertension or non-severe preeclampsia. Eligible participants are those between 23 and 35+6 weeks of pregnancy, expecting a single baby or twins, without severe preeclampsia or other complications that require immediate delivery.Check my eligibility
What is being tested?
This trial tests if lowering blood pressure below 140/90 mmHg in pregnant women with hypertension can extend the duration of their pregnancy. It's a randomized study where some will receive antihypertensive treatment to achieve this target.See study design
What are the potential side effects?
Antihypertensive treatments like labetalol and nifedipine XL may cause side effects such as dizziness, fatigue, headache, swollen ankles or feet (edema), and possible changes in heart rate.
Achieve Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure or mild preeclampsia during my pregnancy.
Select...
I am pregnant and between 23 to 35 weeks along.
Achieve Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to 6 weeks after delivery, up to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 6 weeks after delivery, up to 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean number of days from randomization to delivery
Secondary outcome measures
Maternal healthcare utilization
Maternal morbidity
Neonatal healthcare utilization
+1 moreAchieve Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Antihypertensive treatment for a BP goal of less than 140/90 mmHg
Group II: Usual CareActive Control1 Intervention
Antihypertensive treatment only if BP ≥ 160/110 mmHg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antihypertensive treatment
2012
Completed Phase 4
~400
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,586 Previous Clinical Trials
2,280,100 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,310,980 Total Patients Enrolled
Rachel Sinkey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take labetalol or nifedipine XL due to adverse reactions.Your baby is smaller than most babies at the time of enrollment.You are not showing signs of severe preeclampsia or need to deliver the baby right away when you join the study.You are pregnant with one baby or with twins, and your pregnancy is at least 14 weeks along.I have new headaches or vision problems that medication doesn't help.You had an ultrasound to check the baby's development before 21 weeks of pregnancy.I have high blood pressure or mild preeclampsia during my pregnancy.You have severe preeclampsia.I have kidney problems or high blood pressure.Your blood platelet count is less than 100 x 10e9/L.My kidney function is impaired with high creatinine levels.You have very low levels of amniotic fluid less than 2 cm within 48 hours before joining the study.I am pregnant and between 23 to 35 weeks along.I am currently under watchful waiting for my condition.Your membranes are not broken.I am unable or unwilling to follow treatment recommendations.I have a known significant genetic or chromosomal abnormality.I have fluid in my lungs.I have severe pain in my upper abdomen or issues with liver function that are not explained.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the lower age limit for this research trial set at 75 years?
"This trial is appropriate for those aged 14 to 49 years old."
Answered by AI
Is enrollment for this experiment currently available?
"Affirmative. According to clinicaltrials.gov, this medical experiment was posted on February 14th 2023 and is currently looking for participants. 132 patients need to be sourced from 1 individual site."
Answered by AI
How many participants are currently being enrolled in this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this research is still in need of participants and was posted on February 14th 2023 with a recent update on February 21st 2023. 132 individuals are being sought across one single location."
Answered by AI
What are the eligibility requirements for participants in this trial?
"This clinical trial is enrolling 132 patients with preeclampsia prophylaxis between ages 14 to 49. Eligibility criteria include: singleton gestation after the first trimester, intact membranes, gestational age of 23 weeks 0 days - 35 weeks 6 days, a non-severe form of preeclampsia at enrollment, no signs of severe features as outlined by maternal exclusions, an absence of indications for delivery prior to enrollment, planned expectant management upon entry into the study and confirmed prenatal care or another healthcare visit within 21 weeks that includes documented blood pressure readings."
Answered by AI
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