Status:
COMPLETED
Chronic Hypertension and Pregnancy (CHAP) Project
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Columbia University
Drexel University College of Medicine
Conditions:
Hypertension
Eligibility:
FEMALE
12+ years
Phase:
PHASE4
Brief Summary
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) c...
Detailed Description
During pregnancy, chronic hypertension (CHTN) is the most common major medical disorder encountered, occurring in 2-6%. The substantial negative effect of CHTN on pregnancy includes a consistent 3- to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
2408 Patients enrolled
Trial Details
Trial ID
NCT02299414
Start Date
June 1 2015
End Date
December 16 2022
Last Update
May 17 2023
Active Locations (72)
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1
University of Alabama at Birmingham, Clinical Coordinating Center
Birmingham, Alabama, United States, 35294
2
University of Alabama at Birmingham, Data Coordinating Center
Birmingham, Alabama, United States, 35294
3
University of South Alabama
Mobile, Alabama, United States, 36604
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205