Frequency and Dosing of Long Acting Anti-Hypertensive Agent in Women With Pre-eclampsia With Severe Features Undergoing Expectant Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Comparing the rates of suboptimal blood pressure
研究概览
简要总结
The investigators propose a randomized controlled unblinded trial to evaluate rates of optimal blood pressure control between Nifedipine 60mg XL once daily vs. Nifedipine 30mg XL twice daily in patients admitted for expectant management with pre-eclampsia with severe features. Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg.
详细描述
This is a randomized controlled unblinded trial at The Ohio State University comparing Nifedipine XL 60mg daily to 30mg twice daily in patients admitted for expectant management for pre-eclampsia with severe features.
Potential study participants will be identified at the time of admission to the antepartum unit. Inclusion criteria must be met, namely patient's age, gestational age, diagnosis of preeclampsia with severe features.
Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg. Participants will be randomized in to one of two groups:
- Once daily Nifedipine XL 60mg Vs.
- Twice daily Nifedipine XL 30mg
Once enrolled and randomized, blood pressures will be monitored every 4 hours as is standard on the antepartum unit. Blood pressures for the primary outcome will be collected 24 hours after the patient is randomized and initiated on their above regimen. This is to allow the medication to reach steady state prior to collected information on optimal blood pressures. The primary outcome will consist of blood pressure values collected q4 hours beginning 24h-48h after receiving their first dose of the randomized dose regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 33 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria.
- •Undergoing expectant management for a diagnosis of preeclampsia with severe features and already initiated on 30mg Nifedipine XL. The patient may or may not have already received acute treatment for severe blood pressures.
排除标准
- •Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe GI stricture, and GI hypomotility disorder.
- •Participation in another trial without prior approval
- •Currently receiving a daily dose of Nifedipine XL of 60mg or greater
- •Continuation of alternate long-acting anti-hypertensive medication on admission
- •Physician/provider or patient refusal
- •Triplet or higher order pregnancy
研究组 & 干预措施
Once daily Nifedipine XL 60mg
Participants will receive Nifedipine XL once daily 60 mg for 48 hours.
干预措施: Nifedipine XL (Drug)
Twice daily Nifedipine XL 30mg
Participants will receive Nifedipine XL twice daily 30 mg for 48 hours.
干预措施: Nifedipine XL (Drug)
结局指标
主要结局
Comparing the rates of suboptimal blood pressure
时间窗: on day 2 (24 hour-48 hour) after the patient has been enrolled
Comparing the rates of suboptimal blood pressure, defined as frequency of systolic \>150 mmHg and/or diastolic \>100 mmHg blood pressure. Blood pressure measurements will be measured every 4 hours on day 2 (24 hour-48 hour) after the patient has been enrolled, randomized, and initiated on either once daily Nifedipine XL 60mg or twice daily Nifedipine XL 30mg.
次要结局
- Evaluating mean systolic and diastolic blood pressure and mean arterial pressure(on day 2 (24 hour-48 hour) after the patient has been enrolled)
- Evaluating concentration of Nifedipine in blood(on day 2 (24 hour-48 hour) after the patient has been enrolled)
- Evaluating number of delivery less than 34 weeks(Through study completion, an average of 2 years)
- Evaluating number of days in expectant management from enrollment(Through study completion, an average of 2 years)
- Evaluating frequency of need for acute acting anti-hypertensive treatment (IR Nifedipine, IV labetalol, or IV hydralazine)(on day 2 (24 hour-48 hour) after the patient has been enrolled)
- Evaluating gestational age at delivery(Through study completion, an average of 2 years)
- Evaluating number of route of delivery(Through study completion, an average of 2 years)
- Evaluating frequency of indications for cesarean section(Through study completion, an average of 2 years)
研究者
Kara M Rood, MD
Assistant Professor
Ohio State University