Antihypertensive Therapy for Preeclampsia
(Achieve Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Severe preeclampsia, Renal dysfunction, Stage 2 hypertension, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have contraindications to labetalol and nifedipine XL, which are common blood pressure medications.
What evidence supports the effectiveness of antihypertensive drugs for treating preeclampsia?
Antihypertensive drugs are recommended for severe cases of preeclampsia to lower the risk of serious complications for the mother, such as central nervous system issues. Drugs like labetalol and methyldopa are commonly used and have been shown to be effective in managing high blood pressure in these situations.
12345Is antihypertensive therapy safe for use in preeclampsia?
Medications like methyldopa, labetalol, and nifedipine are considered safe for treating high blood pressure in pregnancy, including preeclampsia. However, some drugs like angiotensin converting enzyme inhibitors and angiotensin receptor blockers should be avoided during pregnancy.
34678How does antihypertensive drug therapy for preeclampsia differ from other treatments?
Antihypertensive drug therapy for preeclampsia is unique because it focuses on managing high blood pressure during pregnancy using medications like hydralazine, labetalol, and methyldopa, which are considered safe and effective. Unlike other treatments, it does not address the underlying cause of preeclampsia, and the ultimate solution for severe cases is often early delivery.
3591011Eligibility Criteria
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.Inclusion Criteria
Prenatal care or healthcare visit with documented blood pressure at less than 21 weeks gestation
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.
+5 more
Exclusion Criteria
I cannot take labetalol or nifedipine XL due to adverse reactions.
Your baby is smaller than most babies at the time of enrollment.
I have new headaches or vision problems that medication doesn't help.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive antihypertensive treatment to maintain blood pressure below 140/90 mmHg
Up to 14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks
Participant Groups
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.
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 β₯ 160/110 mmHg
Antihypertensive treatment is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Antihypertensive medications for:
- Hypertension in pregnancy
- Preeclampsia
πΊπΈ Approved in United States as Antihypertensive medications for:
- Hypertension in pregnancy
- Preeclampsia
- Chronic hypertension
π¨π¦ Approved in Canada as Antihypertensive medications for:
- Hypertension in pregnancy
- Preeclampsia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OschnerNew Orleans, LA
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
[Treatment of hypertensive diseases in pregnancy--general recommendations and long-term oral therapy]. [2013]Hypertensive disorders are among the most common causes of maternal and perinatal mortality. Mild and uncomplicated chronic hypertension has a better prognosis than preeclampsia. The primary aims of therapy are to prevent cerebrovascular complications and to avoid the progression of chronic hypertension into superimposed preeclampsia with worse prognosis. In mild courses of the disease bedrest, whether at home or in the hospital, is commonly recommended. A special diet is not required neither for prevention nor for therapy. This also applies for the use of aspirin. Calcium supplementation during pregnancy seems to be effective in reducing the risk of hypertension and to a smaller extent of preeclampsia. Diuretic therapy is only indicated in exceptional cases. Antihypertensive drugs are recommended, if a sustained blood pressure of diastolic > or = 110 mmHg is recorded, in cases of superimposed preeclampsia even if the diastolic blood pressure is > or = 100 (> or = 90) mmHg. alpha-Methyl-dopa is the initial drug of choice for oral antihypertensive therapy. Neither short-term effects on the fetus or neonate nor long-term effects during infancy have been reported after long-term use of alpha-methyl-dopa in pregnancy. The oral application of beta-adrenergic-antagonist drugs is well-tolerated, but should be avoided in cases of severe fetal growth retardation. Dihydralazine treatment is not suitable for oral therapy, since its medication is associated with maternal side effects such as headache and tachycardia. Administration of drugs that inhibit angiotensin-converting enzyme during pregnancy is contra-indicated. Calcium-channel-blocking drugs are frequently used in the USA and in the UK as "second-line" antihypertensive medication, however there is little experience with the long-term administration of these drugs to pregnant women with hypertension. The indication for hospitalization are of particular clinical importance, since a delay in admission associated with maternal complications may lead to juridical troubles. The antihypertensive treatment is only a symptomatic therapy; the obstetrician must be aware that delivery is the ultimate cure of hypertensive disorders in pregnancy. In women with mild chronic hypertension or mild preeclampsia antihypertensive therapy is unlikely to be beneficial regarding the perinatal results, while in severe forms drug therapy is mandatory to avoid life-threatening maternal complications.
How to manage hypertension in pregnancy effectively. [2023]The hypertensive disorders of pregnancy (HDP) are a leading cause of maternal mortality and morbidity in both well and under-resourced settings. Maternal, fetal, and neonatal complications of the HDP are concentrated among, but not limited to, women with pre-eclampsia. Pre-eclampsia is a systemic disorder of endothelial cell dysfunction and as such, blood pressure (BP) treatment is but one aspect of its management. The most appropriate BP threshold and goal of antihypertensive treatment are controversial. Variation between international guidelines has more to do with differences in opinion rather than differences in published data. For women with severe hypertension [defined as a sustained systolic BP (sBP) of β₯160 mmHg and/or a diastolic BP (dBP) of β₯110 mmHg], there is consensus that antihypertensive therapy should be given to lower the maternal risk of central nervous system complications. The bulk of the evidence relates to parenteral hydralazine and labetalol, or to oral calcium channel blockers such as nifedipine capsules. There is, however, no consensus regarding management of non-severe hypertension (defined as a sBP of 140-159 mmHg or a dBP of 90-109 mmHg), because the relevant randomized trials have been underpowered to define the maternal and perinatal benefits and risks. Although antihypertensive therapy may decrease the occurrence of BP values of 160-170/100-110 mmHg, therapy may also impair fetal growth. The potential benefits and risks do not seem to be associated with any particular drug or drug class. Oral labetalol and methyldopa are used most commonly, but many different Ξ²-adrenoceptor blockers and calcium channel blockers have been studied in clinical trials.
Pathophysiology and medical management of systemic hypertension in preeclampsia. [2019]Hypertension that complicates preeclampsia in pregnancy is a disorder that requires special consideration in both prevention and pharmacologic treatment. In recent years, few advances have been made regarding the pathophysiology and prevention of preeclampsia; however, there have been some promising results from studies on possible modes of screening women for preeclampsia before clinical signs and symptoms are apparent. The recommendations for first-line drug therapy for the hypertensive complications of preeclampsia have changed little, primarily because first-line medications have had the advantage of extensive research experience. Recent clinical trials have demonstrated the efficacy and safety of various second-line drugs for the hypertensive complications of preeclampsia; whether these therapies can eventually replace the standard recommended first-line medications will require more extensive long-term investigation.
Blood pressure medication use and postpartum hospital readmission among preeclampsia patients. [2023]Blood pressure medication is often prescribed to patients with preeclampsia. We are not aware of any study on readmission of those with preeclampsia to the hospital that considers blood pressure medication use or dose.
Pharmacotherapeutic options for the treatment of preeclampsia. [2019]Pharmacotherapeutic options for the treatment of preeclampsia are reviewed.
Hypertension in pregnancy. [2011]Hypertension is a common complication of pregnancy. Preeclampsia, in particular, is associated with substantial risk to both the mother and the fetus. Several risk factors have been recognized to predict risk for preeclampsia. However, at present no biomarkers have sufficient discriminatory ability to be useful in clinical practice, and no effective preventive strategies have yet been identified. Commonly used medications for the treatment of hypertension in pregnancy include methyldopa and labetalol. Blood pressure thresholds for initiating antihypertensive therapy are higher than outside of pregnancy. Women with prior preeclampsia are at increased risk of hypertension, cardiovascular disease, and renal disease.
[Hypertension in pregnancy]. [2007]Hypertension affects approximately 10% of all pregnancies and may jeopardize maternal and fetal health. Chronic hypertension must be distinguished from pre-eclampsia, that can be associated with a bad outcome. An antihypertensive treatment is advocated when systolic blood pressure is > or = 160 mmHg or diastolic blood pressure is > or = 110 mmHg. Hospitalisation is mandatory if there is an associated proteinuria. Labetalol, nifedipine and methyldopa are the commonly used blood-pressure lowering drugs and they are considered safe during pregnancy. Angiotensin converting enzymes inhibitors and angiotensin II receptor blockers are contraindicated, even during the first trimester of pregnancy. The prescription of diuretics during pregnancy should be avoided.
Antihypertensive drugs in pregnancy. [2011]Blood pressure targets and medications that are safe differ in pregnant women compared with nonpregnant individuals. The principles of treatment for mild, moderate, and severe hypertension in pregnancy, chronic versus gestational versus preeclampsia, and women hypertensive at term versus remote from term are reviewed. The choice of antihypertensive drugs also is discussed; methyldopa, labetalol, and nifedipine, among others, appear safe for use in pregnancy, whereas angiotensin converting enzyme inhibitors and angiotensin receptor blockers should be avoided. The management of increased blood pressure in the postpartum period, and agents to use in lactation, are also discussed.
[Hypertension and its treatment in pregnancy]. [2006]Hypertensive disorders complicate approximately 10% of all pregnancies, about half due to transient and essential hypertension and the rest due to preeclampsia that continues to be a major contributor to maternal and perinatal mortality. However, when hypertensive pregnancies are carefully monitored, the neonatal mortality is low. Therefore, identification of women destined to have preeclampsia is essential, and it is the major purpose of the new classification proposed by M. A. Brown and M. L. Buddle to better stratify those hypertensive pregnant women who are at high risk and need intensive inpatient management. Prophylactic low-dose aspirin appeared to prevent preeclampsia in some studies and to be reasonably safe; however, the effectiveness in reducing the incidence of severe preeclampsia and improving pregnancy outcome remains uncertain. The basic therapy for hypertension during pregnancy is now hydralazine, labetalol and methyldopa; for preeclampsia the cornerstone for treatment is magnesium sulphate and hydralazine intravenously, and small doses of diazoxide, if necessary. Diuretics have a dubious place in treatment of hypertension during pregnancy, and ACE-inhibitors are contraindicated. In severe preeclampsia and eclampsia, the only solution is delivery; better knowledge of etiology and pathogenetics is needed for effective and safe treatment of gestational hypertension, as well as careful blood pressure monitoring and adequate laboratory control.
[Pre-eclampsia treatment according to scientific evidence]. [2011]Hypertensive disorders in pregnancy deserve special attention in the setting of global public health. Currently, they represent the third cause of maternal mortality in the world and first in Brazil. From a practical standpoint, pre-eclampsia remains a syndrome that leads to serious repercussions on maternal and fetal mortality and its etiology is not well known. Currently, the best treatment for forms of pre-eclampsia is being discussed at different times in pregnancy and puerperium, with the objective to reduce the high rates of maternal and fetal morbidity and mortality. Considering the pathophysiology of the event, anticipation of delivery is the best treatment for pre-eclampsia. The use of magnesium sulfate is recommended in all cases of severe pre-eclampsia and eclampsia for prevention and treatment of seizures. Likewise, treatment of hypertensive crises is recommended. Hydralazine, nifedipine and labetalol have been the most commonly used drugs for this purpose, but their use depends on the familiarity of the treating physician. Antenatal corticoid therapy is indicated whenever there is an imminent risk of preterm delivery between 24 and 34 weeks. In contrast, there is insufficient evidence to recommend bed rest and routine plasma volume expansion, and there is an urgent need for randomized clinical trials to determine whether maintenance antihypertensive treatment in pregnant women has benefits or risks for mothers and fetuses in all clinical forms of disease, particularly in cases of pure pre-eclampsia.
Pharmacologic approaches for the management of systemic hypertension in pregnancy. [2005]Hypertension in pregnancy includes a group of distinct disorders that require special consideration in both prevention and pharmacologic treatment. In recent years, there have been few advances regarding the pathophysiology and prevention of preeclampsia, or in recommendations for first-line drug therapy of the hypertensive complications of preeclampsia. Similarly, the recommendations for pharmacologic treatment of women with chronic hypertension antedating pregnancy have changed little, primarily because first-line medications have the advantage of having been the subjects of extensive research experience. Recent clinical trials have demonstrated the efficacy and safety of various second-line drugs for treating hypertensive disorders of pregnancy; whether these therapies can eventually replace the standard recommended medications will require more extensive long-term investigation.