Chronic Hypertension and Pregnancy (CHAP) Trial Maternal Follow-up Study
Brief description of study
This is a long-term follow up of participants enrolled in the CHAP trial during a 5-year window starting between 0-6 years until 5-10 years after their participation in the original CHAP trial. The goal is to determine whether treatment of mild CHTN in pregnancy influences maternal risk of cardiovascular disease (CVD) and to evaluate the long-term effect of superimposed preeclampsia on CVD outcomes in women who had CHTN.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Hypertension, CHAP
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Gender: Female
The CHAP Maternal Follow-up study will be conducted at primary CHAP RCT participating sites (up to 60 clinical sites including 31 states across the US).
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 for follow-up study:
- 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
19 Mar 2024.
Study ID: 852863
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