[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05989581":3,"trial-entities:NCT05989581":100,"trial-summary:NCT05989581":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":61,"locations":65,"central_contacts":90,"overall_officials":97,"references":98,"see_also_links":99},"NCT05989581","IRB-3000010726","Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project","Treatment of American Heart Association\u002FAmerican College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial","RECRUITING","2026-12-31","2026-04","2026-08-11","2024-04-24","University of Alabama at Birmingham","OTHER",false,"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\\\u003C130\u002F80mmHg 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 \\\u003C130\u002F80mmHg or usual care to treatment only if BPs ≥140\u002F90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\\\u003C130\u002F80mmHg and 37 to usual care.",null,[19],"Hypertension in Pregnancy",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},74,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Labetalol or Nifedipine","The choice of anti-HTN will be based on the patient and provider's experience and preference. First line anti-HTN recommended in pregnancy- labetalol or nifedipine- will be administered to patients. At least weekly, a study team member will review the participants' BPs and, if randomized to intervention and a higher dose is needed to maintain BPs \\\u003C130\u002F80 mmHg, the study team member will communicate with the clinical team, led by a University of Alabama Maternal Fetal Medicine Attending, in order to ensure coordination between the research and clinical care teams. Labetalol will be initiated at 200 mg twice daily and escalated in 200mg \u002Fdose daily until BP\\\u003C130\u002F80mmHg to a maximum dose of 2400mg\u002Fday. Procardia will be initiated at 30mg XL once daily and uptitrated in 30mg increments until a maximum dose of 120mg daily. Postpartum, titration will occur in similar fashion. The patient will be transitioned to her primary care provider for BP management after the 6-week postpartum visit.",[34],"BP goal \u003C130\u002F80mmHg",[36],{"measure":37,"description":38,"timeFrame":39},"Neonatal Birthweight percentile","To determine whether anti-HTN treatment to BP\\\u003C130\u002F80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery","at delivery of infant",[],"FEMALE","14 Years","89 Years",true,{"inclusion":46,"exclusion":53,"raw_text":60},[47,48,49,50,51,52],"Viable singleton gestation","No fetal anomalies","Blood pressures 130-139\u002F80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation","Planning to deliver at UAB Hospital","No indication for pregnancy termination","Receiving care at the UAB prenatal clinics",[54,55,56,57,58,59],"Declines Randomization","Known diagnosis of chronic hypertension ( BP ≥ 140\u002F90mmHg) or current antihypertensive medication use","Fetal demise diagnosed prior to enrollment","Known major structural of chromosomal abnormalities prior to enrollment","Contraindication to first line antihypertensive (Nifedipine\u002F Labetalol)","Comorbidities requiring BP goals \\\u003C 130\u002F80mmHg","Inclusion Criteria:\n\n* Viable singleton gestation\n* No fetal anomalies\n* Blood pressures 130-139\u002F80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation\n* Planning to deliver at UAB Hospital\n* No indication for pregnancy termination\n* Receiving care at the UAB prenatal clinics\n\nExclusion Criteria:\n\n* Declines Randomization\n* Known diagnosis of chronic hypertension ( BP ≥ 140\u002F90mmHg) or current antihypertensive medication use\n* Fetal demise diagnosed prior to enrollment\n* Known major structural of chromosomal abnormalities prior to enrollment\n* Contraindication to first line antihypertensive (Nifedipine\u002F Labetalol)\n* Comorbidities requiring BP goals \\\u003C 130\u002F80mmHg",[62,63,64],"CHILD","ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":87},"UAB","Birmingham","Alabama","35294","United States",[73,78,82,85],{"name":74,"role":75,"phone":76,"email":77},"Donna Campbell","CONTACT","(205) 996-6268","dcampbell@uabmc.edu",{"name":79,"role":75,"phone":80,"email":81},"Victoria Jauk","334-477-1740","vchapman@uab.edu",{"name":83,"role":84},"Rachel Sinkey, MD","PRINCIPAL_INVESTIGATOR",{"name":86,"role":84},"Ayodeji Sanusi, MD",{"lat":88,"lon":89},33.52066,-86.80249,[91,94],{"name":92,"role":75,"phone":93,"email":77},"Donna Dunn, PhD","12058739503",{"name":95,"role":75,"email":96},"Jhana Plump","jplump@uabmc.edu",[],[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"Gestational Hypertension",[],{"nct_id":4,"found":44,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional pilot study planning to enroll 74 participants. Participants will be randomly assigned to one of two groups: active treatment with Labetalol or Nifedipine, or usual care.","completed","CHAP2 Pilot Project for Hypertension in Pregnancy","This pilot study, called CHAP2, is looking at how treating mild high blood pressure (hypertension) during pregnancy might affect the baby's birth weight. If you are pregnant, between 14 and 89 years old, and have blood pressure readings between 130-139\u002F80-89mmHg before 20 weeks of pregnancy, you might be eligible. You would also need to be planning to deliver at UAB Hospital and receiving care at their prenatal clinics. The study will compare two approaches: one group will receive medication (Labetalol or Nifedipine) to keep blood pressure below 130\u002F80mmHg, and the other group will receive usual care, where treatment starts if blood pressure is 140\u002F90mmHg or higher. The main goal is to see if treating blood pressure to a lower target changes the baby's birth weight percentile at delivery. This study aims to gather information for a larger future study.","Participants are followed until the delivery of the infant, when neonatal birthweight percentile is measured.",139,"At least weekly, a study team member will review participants' blood pressure readings. The study's primary endpoint, neonatal birthweight percentile, is measured at the delivery of the infant.","Not stated in the trial record.",[31],"v2"]