Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy

Hypertensive Disorder of Pregnancy Clinical Trial

Official title: Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a postpartum physical activity intervention after a pregnancy complicated by a Hypertensive Disorder of Pregnancy. The study will also assess the effects of the remote postpartum intervention on blood pressure. To do this, we will recruit individuals that are 3-6 months postpartum a pregnancy complicated by a hypertensive disorder to participate in a 4-month health coaching intervention aimed to promote physical activity and was informed by formative work done previously.

Clinical Trial Description

I.a Clinical and Public Health Significance. CVD is the leading cause of death among women in America; one in four of these deaths are preventable.3 HDP, including gestational and chronic hypertension, preeclampsia, and superimposed preeclampsia, are risk factors for CVD.3 HDP are associated with maternal and offspring morbidity and mortality, negatively impacting cardiovascular, immune, and neurological systems.21 With 10% of all pregnancies affected by HDP, targeting this population is critical to improving maternal/neonatal morbidity and mortality and overall cardiovascular health in America.1,2 The proposed study answers the AHA's call in their 2022 scientific statement for studies demonstrating efficacy of lifestyle interventions addressing hypertension during the postpartum period among those with HDP.22 I.b Cardiovascular changes during pregnancy act as a natural stress test and may uncover an individual's potential risk of future CVD.23 Specifically, individuals with HDP are at an immediately increased risk for HTN after delivery.1 Long-term cardiometabolic health is also implicated by HDP, with increased risk of future CVD, morbidity, and mortality compared to normotensive pregnancies.24 Odds of developing HTN at one year postpartum is 12 to 25 times greater in HDP pregnancies compared to normotensive pregnancies.25 The 5-year likelihood of developing HTN for pregnancies complicated by HDP is 7.1 times greater than normotensive pregnancies.1 Even in those not diagnosed with HTN, the BP is on average greater in HDP women than in normotensive pregnancies.26 I.c Follow-up care for HDP in the postpartum period is inadequate. Although it is understood that HDP place an individual at increased risk for future CVD, only 58% of women with HDP had a 7-10 day postpartum BP check and 48% for a 6-month postpartum visit.4,25 In addition, only 17% of women with HDP follow-up with their primary care providers, indicating a gap in the transition of care after pregnancy.25 Lack of follow-up has been attributed to fatigue, pain, infant care obligations, time, and low awareness of HDP as a risk factor for future CVD.27,28 Although a few interventions have targeted future CVD risk in this population, few to no studies account for these unique barriers experienced during the postpartum period.14,29 I.d PA and SED have independent effects on CVD risk.8-10 PA and SED are modifiable risk factors for CVD and have the potential to improve BP.30 Current studies suggest that moderate to vigorous PA decreases after pregnancy, and evidence concerning SED is conflicting.31,32 PA, specifically aerobic exercise, has beneficial effects on mean, systolic, and diastolic BP in adults.33,34 This association has been observed in pregnant populations as well, with the greatest improvements seen in inactive individuals.35,36 SED is another modifiable risk factor associated with CVD, independent of PA, with each additional hour of SED increasing the risk for HTN.8 Although the effect on PA and SED in the general population are well understood, the direct effects of PA/SED in the postpartum period on BP after HDP is understudied.37 I.e The perinatal period presents a critical period of change and a promising target for lifestyle intervention to reduce future CVD risk. The association of HDP with future CVD elicited AHA's call to action for more vigorous primary prevention of CVD in the postpartum period.38,39 With increased contact to health care professionals during gestation, pregnancy also offers an opportunity to connect with this population to develop positive health behaviors, which our preliminary data confirms is feasible. Interventions promoting PA and decreased SED in the postpartum period after a HDP is an under explored primary prevention strategy.37 ;

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Pregnancy Complications
• Toxemia

• NCT number: NCT06019715
• Study type: Interventional
• Source: University of Iowa
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: July 1, 2024