CHAP Maternal (2023)

This is an image of liquid being dropped into a test tube

This study follows women who participated in the original CHAP trial during pregnancy, which compared different ways of managing mild chronic high blood pressure. Researchers are now tracking these women over time to see whether treating high blood pressure during pregnancy has long-term effects on their heart health. The goal is to better understand how pregnancy complications like preeclampsia may affect future cardiovascular disease risk.

Study Status

Enrollment Period

Eligibility Criteria

Age

Adult (18 - 64)

Accepts Healthy Volunteers

Gender

Female

Contact Information

Tulane Center for Clinical Research

504-988-0200

tccr@tulane.edu

_{Select a tab above for more information.}

Who Qualifies for this Study?

Must have participated in the original CHAP Trial during pregnancy.
Must have had a diagnosis of mild chronic hypertension during that pregnancy.
Eligible participants may be between 0–6 years to 10 years postpartum from the time of CHAP trial participation.
Women with or without a history of superimposed preeclampsia during their CHAP trial pregnancy are eligible.

Pregnancy as a Window to the Future: Outcomes of Antihypertensive Therapy and Superimposed Preeclampsia in Pregnant Women with Mild Chronic Hypertension- Chronic Hypertension and Pregnancy (CHAP) Trial Maternal Follow-up Study

Protocol: 2R01HL120338-07

Sponsor: Funded by the National Institutes of Health, National Heart Lung and Blood Institute

The Chronic Hypertension and Pregnancy (CHAP) Project randomized pregnant women with mild chronic hypertension (CHTN) to usual care (i.e. antihypertensive therapy only if the patient experienced severe hypertension defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥105 mmHg) or to intervention (i.e. antihypertensive therapy to goal BP < 140/90 mmHg). The current protocol describes long-term follow up of these women during a 5-year window starting between 0 – 6 years until 5 – 10 years after their participation in the original CHAP trial. The goal is to determine whether treatment of mild chronic hypertension in pregnancy influences maternal risk of cardiovascular disease (CVD) and to evaluate the long-term effect of superimposed preeclampsia on CVD outcomes in women who had CHTN.

Study Overview

This follow-up study builds on the Chronic Hypertension and Pregnancy (CHAP) Trial, which evaluated whether treating mild chronic hypertension during pregnancy improves maternal and infant outcomes. In the original trial, pregnant women with mild chronic hypertension were randomly assigned to either usual care—treatment only if severe hypertension developed—or to an intervention group that received medication to maintain blood pressure below 140/90 mmHg throughout pregnancy.

The current study focuses on the long-term health of the mothers from the CHAP trial. Researchers will monitor participants for up to 10 years after their pregnancy to assess the impact of blood pressure management and superimposed preeclampsia on their cardiovascular health. Funded by the NIH’s National Heart, Lung, and Blood Institute, this study aims to uncover how pregnancy-related hypertension management may influence the future risk of heart disease in women.

Conditions / Diseases

Hypertension (High blood pressure)

Department / Organizations

Tulane Center for Clinical Research (TCCR)

Principal Investigator

ClinicalTrials.gov

Join a Clinical Trial Today

Help advance medicine and make a difference.

Frequently Asked Questions

We understand that deciding to join a clinical trial is a personal choice—and often one that comes with a lot of questions. Whether you're curious about how trials work, wondering about safety, or just want to know what to expect, you're in the right place.

What is a clinical trial?

A clinical trial is a research study that tests how new medical approaches work in people. It helps doctors find better ways to prevent, detect, or treat diseases.

Why should I consider participating?

By joining a clinical trial, you can gain access to new treatments before they’re widely available and help advance medical knowledge that could benefit others in the future.

Is it safe?

Clinical trials follow strict safety protocols and are closely monitored by medical professionals and regulatory agencies to protect participants. Your health and safety are a top priority.

Will I be paid?

Some clinical trials offer compensation for your time and travel. This varies depending on the study. Ask the research team for details.

Can I leave a study at any time?

Yes. Participation is completely voluntary, and you can withdraw at any point for any reason without penalty.

What happens if I have side effects?

All potential risks and side effects will be explained to you before the study begins. If you experience any issues, the study team will monitor and support you with appropriate care.

Will my personal information be kept private?

Yes. Your data is kept confidential and is only used for research purposes in accordance with privacy laws and ethical standards.

Do I need health insurance to participate?

Not usually. Most trials cover the cost of the study-related care. You should ask the study coordinator for specifics.

Information for

University Info