Chronic Hypertension and Pregnancy (CHAP) Project

(CHAP Trial)

Recruiting at71 trial locations

Overseen by Alan Tita, MD, PhD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

Research Team

Gary Cutter, PhD

Principal Investigator

University of Alabama at Birmingham-Data Coordinating Center

Jeff Szychowski, PhD

Principal Investigator

University of Alabama at Birmingham-Data Coordinating Center

Alan Tita, MD, PhD

Principal Investigator

University of Alabama at Birmingham - Clinical Coordinating Center

Eligibility Criteria

Inclusion Criteria

You have Singleton syndrome.

OR chronic hypertension with proteinuria with blood pressure 140-159/90-104 on any antihypertensive therapy Women with chronic hypertension in pregnancy who have a blood pressure of 140-159/90-104, either with new or untreated hypertension, or who have a known history of chronic hypertension and are on monotherapy with any antihypertensive drug, will have their blood pressure monitored and if it remains at or below 159/104, they will be considered for discharge.

A viable pregnancy is a pregnancy that is 23 weeks of gestation or older.

Treatment Details

Interventions

• Anti-hypertensive therapy (Anti-hypertensive)
• No anti-hypertensive therapy (unless BP is severe) (Other)

Participant Groups

Group I: Anti-hypertensive therapy to goal <140/90 mmHg Experimental Treatment 1 Intervention

Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used

Group II: No anti-hypertensive unless BP is severe (≥160/105 mmHg Active Control 1 Intervention

Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Latter Day Saints Hospital

Collaborator

Trials

2

Recruited

2,400+

Duke Regional Hospital

Collaborator

Trials

2

Recruited

2,400+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Shannon Sullivan

Women and Infants Hospital of Rhode Island

Chief Executive Officer since 2020

Executive Master’s degree in Healthcare Leadership from Brown University, Master’s degree in Social Work from Boston College

Dr. Lisa Rameaka

Women and Infants Hospital of Rhode Island

Chief Medical Officer

MD from Robert Larner, M.D. College of Medicine at the University of Vermont, MBA from the University of Massachusetts

McKay-Dee Hospital

Collaborator

Trials

2

Recruited

2,800+

Lyndon B Johnson General Hospital

Collaborator

Trials

1

Recruited

2,400+

Virtua Medical Group

Collaborator

Trials

2

Recruited

3,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Miami Valley Hospital

Collaborator

Trials

1

Recruited

2,400+

Utah Valley Regional Medical Center

Collaborator

Trials

1

Recruited

2,400+