RECRUITING

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.

Official Title

Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial

Quick Facts

Study Start:2024-04-24
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05989581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 89 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Viable singleton gestation
  2. * No fetal anomalies
  3. * Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation
  4. * Planning to deliver at UAB Hospital
  5. * No indication for pregnancy termination
  6. * Receiving care at the UAB prenatal clinics
  1. * Declines Randomization
  2. * Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use
  3. * Fetal demise diagnosed prior to enrollment
  4. * Known major structural of chromosomal abnormalities prior to enrollment
  5. * Contraindication to first line antihypertensive (Nifedipine/ Labetalol)
  6. * Comorbidities requiring BP goals \< 130/80mmHg

Contacts and Locations

Study Contact

Donna Dunn, PhD
CONTACT
12058739503
dcampbell@uabmc.edu
Jhana Plump
CONTACT
jplump@uabmc.edu

Study Locations (Sites)

UAB
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension in Pregnancy