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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
Must not have
Contraindications to labetalol and nifedipine XL
New-onset headache or visual disturbances unresponsive to medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 6 weeks after delivery, up to 20 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take labetalol or nifedipine XL due to adverse reactions.
Select...
I have new headaches or vision problems that medication doesn't help.
Select...
I have kidney problems or high blood pressure.
Select...
My kidney function is impaired with high creatinine levels.
Select...
I am unable or unwilling to follow treatment recommendations.
Select...
I have a known significant genetic or chromosomal abnormality.
Select...
I have fluid in my lungs.
Select...
I have severe pain in my upper abdomen or issues with liver function that are not explained.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean number of days from randomization to delivery
Secondary study objectives
Maternal healthcare utilization
Maternal morbidity
Neonatal healthcare utilization
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,656 Previous Clinical Trials
2,444,241 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,697 Total Patients Enrolled
Rachel Sinkey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
440 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.