Cardiometabolic Risk in Pregnancy and Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Carotid-Femoral Pulse Wave Velocity (PWV)
研究概览
简要总结
The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •18 years and older
- •3rd trimester of pregnancy at enrollment
- •Will be living in the area for the study duration
- •Women with or without pregnancy complications (e.g., gestational hypertension, preeclampsia, gestational diabetes)
排除标准
- •Multiple births
- •Diagnosed CVD or diabetes prior to pregnancy
- •Renal or other serious maternal diseases pre-pregnancy
研究组 & 干预措施
Postpartum Cardiovascular Disease (CVD) Risk Reduction Program
The participants assigned to the PP-CVD Risk Reduction arm receive a structured cardiovascular disease risk-reduction program that includes home blood pressure monitoring and weekly postpartum education sessions on heart health after pregnancy, nutrition, physical activity, stress management, sleep, weight management, medication adherence, and long-term cardiovascular health for postpartum women.
干预措施: Postpartum Cardiovascular Disease (CVD) Risk Reduction Program (Behavioral)
Enhanced Postpartum Care
The participants assigned to the Enhanced Postpartum Care arm receive a structured postpartum support program that includes home blood pressure monitoring and scheduled maternal-infant health check-ins, providing education on postpartum recovery, infant care, mental health, nutrition, infection prevention, and family planning to support maternal health during the postpartum period.
干预措施: Enhanced Postpartum Care (Behavioral)
结局指标
主要结局
Change in Carotid-Femoral Pulse Wave Velocity (PWV)
时间窗: Baseline, 3 months after birth, and 6 months after birth
Change in arterial stiffness measured as carotid-femoral pulse wave velocity (PWV), expressed in meters per second (m/s), assessed using the Vicorder® system, defined as the difference in PWV measured during baseline, 3 months after birth, and 6 months after birth.
次要结局
- Change in Systolic Blood Pressure(Baseline, 3 months after birth, and 6 months after birth)
- Change in Diastolic Blood Pressure(3 months after birth, and 6 months after birth)
- Change in cardiometabolic and vascular biomarkers(Baseline, 3 months after birth, and 6 months after birth)
- Systolic Blood Pressure(Baseline, 3 months after birth, and 6 months after birth)
- Diastolic Blood Pressure(Baseline, 3 months after birth, and 6 months after birth)
研究者
Forgive Avorgbedor
Assistant Professor
University of North Carolina, Greensboro