Blood Pressure Treatment Goals for Preeclampsia
(GOALPOST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores optimal blood pressure management in pregnant individuals with gestational hypertension or mild preeclampsia. It examines whether using anti-hypertensive medication to maintain blood pressure below 140/90 mmHg results in better pregnancy outcomes compared to usual care, which initiates treatment only if blood pressure reaches 160/110 mmHg. Eligible participants should be between 23 and 35 weeks pregnant, carrying one baby or non-identical twins, and have a recent diagnosis of high blood pressure without severe symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to significant advancements in pregnancy care.
Will I have to stop taking my current medications?
If you are currently taking medication to lower blood pressure, you may need to stop for 48 hours before joining the trial. This is called a 'washout period' (time without taking certain medications).
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that treating high blood pressure during pregnancy is generally safe. Research indicates that medications like labetalol and nifedipine, commonly used for this purpose, do not increase the risk of harmful effects for the mother or baby. Labetalol, for example, is often used and well-tolerated by many pregnant patients. Nifedipine, another option, has also proven safe during pregnancy, with no significant increase in negative outcomes reported.
Overall, these medications can lower the risk of serious pregnancy complications, such as preeclampsia (a condition with high blood pressure and potential organ damage) and early birth. This evidence shows that managing blood pressure in pregnant women can provide protective benefits without adding unnecessary risk.12345Why do researchers think this study treatment might be promising for preeclampsia?
Researchers are excited about this trial because it explores different blood pressure goals for managing preeclampsia, a condition that affects pregnant women. Unlike the usual care, which starts treatment when blood pressure reaches 160/110 mmHg, the experimental approach aims to keep blood pressure below 140/90 mmHg. This could potentially improve outcomes by reducing the risks associated with higher blood pressure levels earlier in the pregnancy. By investigating these different treatment goals, researchers hope to find a more effective strategy for managing preeclampsia and ultimately improve maternal and fetal health.
What evidence suggests that this trial's treatments could be effective for preeclampsia?
Research has shown that controlling blood pressure during pregnancy can improve health outcomes for both mother and baby. This trial will compare two approaches: one group will use anti-hypertensive medication titrated to a blood pressure goal of <140/90 mmHg, while the other will follow usual care with medication for blood pressure ≥160/110 mmHg, titrated to a goal of <160/110 mmHg. Studies have found that managing blood pressure with medication can lower the risk of preeclampsia, a condition characterized by high blood pressure. Specifically, one study found that actively managing blood pressure reduced the chance of serious pregnancy problems, such as severe preeclampsia, by 18%. Another study noted that certain medications, like labetalol, can reduce the risk of preeclampsia and early birth. Maintaining blood pressure below 140/90 mmHg is associated with fewer complications and better health outcomes for both mother and baby.23467
Who Is on the Research Team?
Alan TN Tita, MD PHD
Principal Investigator
University of Alabama at Birmingham
Rebecca G Clifton, PhD
Principal Investigator
The George Washington University Biostatistics Center
Laurie B Griffin, MD
Principal Investigator
University of Utah Health Sciences
Rachel G Sinkey, MD
Principal Investigator
University of Alabama at Birmingham
Dwight J Rouse, MD
Principal Investigator
Brown University
Are You a Good Fit for This Trial?
This trial is for pregnant individuals between 23 and almost 36 weeks who have gestational hypertension or preeclampsia without severe symptoms. Participants should not have very high blood pressure (≥160/110 mmHg) or other serious complications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either antihypertensive medication to achieve a target BP <140/90 mmHg or usual care with no medication unless BP increases to ≥160/110 mmHg.
Follow-up
Participants are monitored for maternal and neonatal outcomes, including a follow-up visit at 6 weeks postpartum.
What Are the Treatments Tested in This Trial?
Interventions
- Anti-hypertensive medication
Trial Overview
The study compares two ways of treating high blood pressure in pregnancy: one group gets medication to keep BP below 140/90, while the other only receives treatment if BP reaches at least 160/110. Participants are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
The George Washington University Biostatistics Center
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Alabama at Birmingham
Collaborator
University of Utah
Collaborator
Brown University
Collaborator
Citations
Drug Treatment of Hypertension in Pregnancy - PMC - NIH
In preeclampsia, antihypertensive therapy can be withheld unless there is persistent DBP 105–110 mmHg or higher (III-C).
The “Preeclampsia and Hypertension Target Treatment ...
Maintaining strict control of the mother's blood pressure (BP) through proper medication has been shown to enhance pregnancy outcomes.4, using a first-line ...
Hypertension in Pregnancy and Postpartum
Labetalol is commonly used to treat hypertension in pregnant and postpartum patients, but twice-daily or more frequent dosing is a major ...
Oral antihypertensive treatment during pregnancy
In the network meta-analysis, labetalol vs nifedipine was associated with a reduction in preeclampsia (relative risk, 0.50 [0.28–0.87]; 15 studies) and preterm ...
Hypertension and Pregnancy Treatment & Management
a meta-analysis reported an approximate 15% reduction in preeclampsia among pregnant women taking low-dose ASA when women began taking it ...
Antihypertensive Medications for Severe Hypertension in ...
Oral nifedipine was relatively safe and showed no difference in the risk of hypotension, maternal and fetal outcomes, and incidence of adverse ...
7.
newsroom.heart.org
newsroom.heart.org/news/high-blood-pressure-treatment-in-pregnancy-is-safe-prevents-maternal-heart-risksHigh blood pressure treatment in pregnancy is safe ...
High blood pressure treatment in pregnancy is safe, prevents maternal heart risks · Dietary changes before and during pregnancy can limit weight ...
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