CHAP Maternal Follow-Up Study
D
David Haas, MD
Primary Investigator
Overview
This protocol describes
the epidemiology, international controversy and current state of knowledge
regarding long-term maternal outcomes among women with mild CHTN who received
antihypertensive therapy in pregnancy or who had preeclampsia. This document is
considered a written agreement between participating investigators and their
corresponding centers. Changes to the protocol during the study period require
approval from the Steering Committee and Institutional Review Boards.
Description
To test the hypothesis that
antihypertensive therapy during pregnancy for mild CHTN (BP goal <140/90)
compared with no treatment (unless BP is severe) reduces the incidence of
adverse CVD outcomes 5 to 10 years later (including the primary composite of
progression to severe hypertension ≥160/110 mmHg, chronic kidney disease (CKD),
deep venous thromboembolism (VTE), heart failure, stroke, myocardial
infarction/angina, or death).
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Pregnancy, hypersensitive
-
Age: Between 18 Years - 100 Years
-
Gender: Female
Inclusion Criteria:
- All women with mild CHTN who were randomized into CHAP between 2015 and 2021.- Recall CHAP Inclusion criteria were: Confirmed mild CHTN (either new/untreated with BP 140 – 159/90-104 mmHg OR known monotherapy with BP ≤ 159/104 mmHg); Singleton live fetus; Gestational age < 23 weeks- Recall CHAP Exclusion criteria were: Severe CHTN (recurrent BP ≥ 160/110 mmHg or on 2 or more antihypertensive drugs); Allergy to labetalol and nifedipine; Known secondary cause for CHTN; Current or prior CVD; Imminent threat to the fetus (major anomaly, FGR, membrane rupture)
Exclusion Criteria:
- - Declined to be contacted for the follow-up study or cannot be contacted- Sites that are unable to participate in the follow up*If pregnant, follow-up for required in-person visit will be deferred until at least 12 weeks postpartum but this is not an exclusion
Updated on
03 May 2024.
Study ID: 17888; OBGYN-IIR-CHAP-MATERNAL
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