U01HD114633

Gestational hypertension and preeclampsia blood pressure (BP) treatment goals <140/90 vs. <160/110 mmHg: The Goalpost Trial - Abstract

Hypertensive disorders of pregnancy (HDP) affect up to 1 in 8 pregnancies and lead to significant short and long-term morbidity and mortality for mothers and neonates.

HDPs are classified as non-severe and severe.

In non-severe forms of HDP, specifically gestational hypertension or preeclampsia without severe features, pregnant individuals have elevated systolic blood pressure (BP) between 140 – 159 mmHg and/or elevated diastolic BP 90 – 109 mmHg without evidence of end-organ dysfunction.

In contrast, severe HDP, including preeclampsia with severe features and eclampsia, is characterized by severe hypertension defined as BP ≥160/110 mmHg or evidence of end-organ damage such as liver or kidney dysfunction or seizures.

Although delivery minimizes risks to the mother, depending on the gestational age, delivery may lead to increased risks for the neonate, particularly adverse outcomes associated with prematurity.

Five percent or more of all pregnancies are affected by non-severe HDP at <370 weeks.

The standard of care is to expectantly manage patients with non-severe HDP with close observation and serial surveillance until 370 weeks gestation or when severe disease develops, whichever occurs first, at which time delivery is indicated.

Unfortunately, non-severe HDP progresses to severe HDP in 30 - 50% of cases <370 weeks gestation.

As such, it is critical to identify interventions to safely reduce the progression from non-severe to severe HDP.

A recent trial in pregnant women with chronic hypertension demonstrated that treatment of BP to a goal of <140/90 decreases the risk of preeclampsia and improves outcomes for mother and baby.

Based on this, clinical guidelines were changed and now recommend a BP goal <140/90 for all pregnant individuals with chronic hypertension.

However, no definitive trial has been performed demonstrating that BP goals <140/90 in non-severe HDP are beneficial and safe, leaving the clinical question: Does starting oral antihypertensive medication when a patient develops a non-severe HDP prolong gestation and benefit the mother and infant without increasing maternal or fetal risks?

Therefore, we propose the Goalpost Trial, a Phase III, open-label randomized control trial (N=4,120) of antihypertensive treatment in pregnant individuals with non-severe HDP conducted through the NICHD Maternal-Fetal Medicine Units Network.

Participants will be randomized 1:1 to 1) Intervention – oral antihypertensive therapy to targeted BP goals <140/90 mmHg or 2) Usual care – no antihypertensive therapy unless BP ≥160/110 mmHg.

We will evaluate whether the intervention reduces adverse pregnancy (primary aim) and neonatal outcomes (secondary aim).

A comprehensive safety plan will ensure close clinical monitoring of mother and fetus to enhance safety.

The Goalpost Trial has the potential to change management guidelines for the treatment of non-severe hypertensive disorders of pregnancy in the US and worldwide and to improve outcomes for countless women and children.

George Washington University (The)

NOT APPLICABLE

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Rockville, Maryland 208523943 United States

Single Zip Code

Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional) (PAR-23-037)

Amendment Since initial award the total obligations have increased 154% from $2,011,151 to $5,117,920.