The CHIPS Trial (Control of Hypertension In Pregnancy Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 987
- 试验地点
- 117
- 主要终点
- Pregnancy Loss or NICU Admission for Greater Than 48 Hours
研究概览
简要总结
The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies.
In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.
详细描述
Primary research question:
For pregnant women with non-severe, non-proteinuric maternal hypertension at 14-33 weeks, will 'less tight' control (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) increase (or decrease) the likelihood of pregnancy loss or Neonatal Intensive Care Unit (NICU) admission for greater than 48 hours?
Secondary research question:
Will 'less tight' versus 'tight' control increase (or decrease) the likelihood of serious maternal complications?
Other research questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-existing or gestational hypertension (pre-existing hypertension is dBP greater than or equal to 90 mmHg before pregnancy or 20 weeks' gestation; gestational hypertension is dBP greater than or equal to 90 mmHg that develops after 20 weeks)
- •dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
- •Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
- •Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)
排除标准
- •Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation)
- •Proteinuria (defined as greater than or equal to 0.3 g/d by 24 hour urine collection, or if a 24 hour urine collection is not available, by a urinary protein:creatinine ratio of greater than or equal to 30 mg/mmol or urinary dipstick of greater than or equal to 2+)
- •Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation
- •Contraindication to either arm of the trial or to pregnancy prolongation
- •Known multiple gestation
- •Known lethal or major foetal anomaly
- •Plan to terminate pregnancy
- •Prior participation in CHIPS
结局指标
主要结局
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
时间窗: 6 weeks
Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.
次要结局
- Serious Maternal Complications Measured up to 6 Weeks Postpartum(6 weeks)