Chronic Hypertension and Pregnancy (CHAP) Project

  • STATUS
    Recruiting
  • End date
    Jun 7, 2022
  • participants needed
    2404
  • sponsor
    University of Alabama at Birmingham
Updated on 7 May 2021
hypertension
antihypertensive drugs

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) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

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 5-fold increase in superimposed preeclampsia and adverse perinatal outcomes (fetal or neonatal death, preterm birth -PTB, poor fetal growth and placental abruption) and possibly a 5- to10-fold increase in maternal cardiovascular and other complications (death, cerebrovascular accident, pulmonary edema and acute renal failure). Mild CHTN (BP <160/110) contributes to a large proportion of these adverse outcomes. While antihypertensive treatment of CHTN is standard for the general population, it is uncertain whether treatment during pregnancy reduces maternal or fetal complications, and there are concerns that decreased arterial pressure may reduce fetal blood flow and cause poor fetal growth or small-for-gestational-age (SGA) infants. Some authorities, including the American College of Obstetricians and Gynecologists (ACOG) and American Society of Hypertension (ASH) recommend withholding antihypertensive therapy for mild CHTN, particularly if BP is <160/105-110 mmHg. The recommendation to withhold antihypertensive treatment in pregnancy conflicts with the broader public health goal to reduce BP in those with CHTN and there is no evidence that discontinuing therapy during the brief period of pregnancy affects maternal outcomes (other than reducing the severe hypertension). For over a decade, authorities have consistently called for well-designed and powered trials to delineate the benefits and risks of pharmacologic therapy for CHTN during pregnancy.

Therefore, our multicenter consortium proposes the Chronic Hypertension and Pregnancy (CHAP) Project, a large pragmatic randomized trial with a primary aim to evaluate the benefits and harms of pharmacologic treatment of mild CHTN in pregnancy.

Details
Condition Vascular Diseases, Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment Anti-hypertensive therapy, No anti-hypertensive therapy (unless BP is severe)
Clinical Study IdentifierNCT02299414
SponsorUniversity of Alabama at Birmingham
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Blood pressures prior to randomization 160 systolic or 105 diastolic (with or without treatment)
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
Class C or higher diabetes mellitus
Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, p/c 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
Cardiac disorders: cardiomyopathy, angina, CAD
Prior stroke
Retinopathy
Sickle cell disease; 6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. 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; 11. Contraindication to labetalol or nifedipine (e.g. know hypersensitivity); and (12) Current substance abuse or addiction (cocaine, methamphetamine) The minimum age varies by center
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