Blood Pressure Treatment Goals for Preeclampsia

(GOALPOST Trial)

Not yet recruiting at 13 trial locations
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RG
Overseen ByRebecca G Clifton, PhD
Age: < 65
Sex: Female
Trial Phase: Phase 3
Sponsor: The George Washington University Biostatistics Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

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Alan TN Tita, MD PHD

Principal Investigator

University of Alabama at Birmingham

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Rebecca G Clifton, PhD

Principal Investigator

The George Washington University Biostatistics Center

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Laurie B Griffin, MD

Principal Investigator

University of Utah Health Sciences

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Rachel G Sinkey, MD

Principal Investigator

University of Alabama at Birmingham

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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

Singleton or di-chorionic twin gestation
I was diagnosed with mild gestational hypertension or preeclampsia in the last 10 days.
Gestational hypertension or preeclampsia defined as new onset systolic blood pressure 140-159 or diastolic blood pressure 90-109 on two occasions at least four hours apart on or after 20 weeks 0 days gestation with normal end-organ labs, with or without proteinuria
See 3 more

Exclusion Criteria

I am allergic to both labetalol and nifedipine ER.
I have retinopathy (an eye disease affecting the retina).
Two blood pressure measurements ≥ 140/90 at least 4 hours apart prior to 20 weeks 0 days in the current pregnancy
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

Up to 13 weeks
At least weekly clinical visits until delivery, with twice-weekly research staff encounters

Follow-up

Participants are monitored for maternal and neonatal outcomes, including a follow-up visit at 6 weeks postpartum.

6 weeks postpartum
1 visit (in-person) 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

Group I: Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHgExperimental Treatment1 Intervention
Group II: Anti-hypertensive medication titrated to a BP goal of <140/90 mmHgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The George Washington University Biostatistics Center

Lead Sponsor

Trials
27
Recruited
111,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Brown University

Collaborator

Trials
480
Recruited
724,000+

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 ...

High 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 ...