Chronic Hypertension and Pregnancy (CHAP) Project

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT02299414

Run by

University of Alabama at Birmingham

People needed

2408

Starts

2015-06-01

Expected to finish

2022-12-16

Last updated by the study team

2023-05-17

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure <140/90);
• Singleton; and
• viable pregnancy <23 weeks of gestation.

You may not qualify if…

• Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment);
• Severe hypertension including patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension);
• Multi-fetal pregnancy;
• Known secondary cause of chronic hypertension;
• High-risk co-morbidities for which treatment may be indicated:
• Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years
• Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant)
• Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria*) or creatinine >1.2.
• If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg.
• Cardiac disorders: cardiomyopathy, angina, CAD
• Prior stroke
• Retinopathy
• Sickle cell disease
• Known major fetal anomaly;
• Known fetal demise;
• Suspected IUGR;
• Membrane rupture or planned termination prior to randomization;
• Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial;
• Contraindication to labetalol and nifedipine (e.g. know hypersensitivity);
• Current substance abuse or addiction (cocaine, methamphetamine)
• Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee)
• Physician or provider refusal
• Patient refusal *The minimum age varies by center

Where it is running

• University of Alabama at Birmingham, Data Coordinating Center — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• University of California, San Diego — San Diego, California, United States
• General Hospital of San Francisco — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Boulder, Colorado, United States
• Denver Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care Health Services — Newark, Delaware, United States
• University of South Florida — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern — Evanston, Illinois, United States
• Indiana University — Bloomington, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Lawrence, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Tulane — New Orleans, Louisiana, United States
• Ochsner Health System/Medical Center — New Orleans, Louisiana, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• University of Mississippi Medical College — Jackson, Mississippi, United States
• Washington University — St Louis, Missouri, United States
• University of Alabama at Birmingham, Clinical Coordinating Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.