Management of Hypertension in the Early Postpartum Period: Randomized Clinical Trial Comparing Two Antihypertensive Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Values of heart rate
研究概览
简要总结
In hypertensive mothers, it is common in clinical practice to substitute methyldopa for another medication, such as captopril, immediately after delivery, which may, as a consequence, cause a rebound effect or an initial lack of blood pressure control until the new medication had a more complete action. Thus, the treatment of hypertension in the puerperium is generally guided by expert opinion and recommendations for guidelines, based on non-robust evidence. OBJECTIVE: To evaluate the control of blood pressure in postpartum women with hypertensive syndromes during pregnancy with the maintenance of the continued use of previously used methyldopa compared to switching from antihypertensive regimen to the use of captopril. METHOD: Randomized, double-blind, drug controlled clinical trial. EXPECTED RESULT: better pressure control with the continued use of methyldopa.
详细描述
Objective
To evaluate blood pressure control during the immediate postpartum in hypertensive women who had used methyldopa during pregnancy, comparing continuation of that drug with switching it for captopril. Methods: A single-blind, randomized clinical trial involving 180 postpartum women with arterial hypertension who had previously used methyldopa during pregnancy at a minimum dose of 750 mg/day for at least one week prior to delivery. Following delivery, the patients were randomized either to continue with methyldopa (minimum dose 250 mg, three times a day) (methyldopa group, n=90) or to switch to captopril (at an initial dose of 25 mg, three times a day) (captopril group, n=90). Logistic regression will be used to compare the groups regarding the potential to maintain blood pressure below 140/90 mmHg at over 50% of measurements postpartum.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •puerpera;
- •hypertensive;
- •use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery
排除标准
- •Use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or Contraindications to the use of captopril or methyldopa
研究组 & 干预措施
methyldopa
maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum
干预措施: Methyldopa 250 MG (Drug)
captopril
postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum
干预措施: Methyldopa 250 MG (Drug)
结局指标
主要结局
Values of heart rate
时间窗: every 4 hours immediately after the use of medication until hospital discharge
values of heart rate bpm (beat per minute) after starting postpartum medication
Values of blood pressure (dyastolic blood pressure)
时间窗: every 24 hours immediately after the use of medication until hospital discharge
diastolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication
Frequency of hypertensive peaks
时间窗: every 4 hours immediately after the use of medication until hospital discharge
numbers of hypertensive peaks (Systolic Blood Pressure ≥160 mmHg and / or Diastolic Blood Pressure ≥ 110 mmHg) after starting postpartum medication
Values of blood pressure (systolic blood pressure)
时间窗: every 4 hours immediately after the use of medication until hospital discharge
systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication
Values of blood pressure ( mean arterial pressure)
时间窗: every 4 hours immediately after the use of medication until hospital discharge
mean blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication
次要结局
- Profile of the following laboratory tests (creatinine) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests alanine transferase (ALT) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Frequency of adverse effects most often described with medications ( yes or no)(immediately after the use of medication until hospital discharge)
- degree of maternal satisfaction with medication(immediately after the use of medication until hospital discharge)
- Neonatal outcomes (Hypothermia) -yes or no(immediately after the use of medication until hospital discharge)
- Profile of the following laboratory tests (total bilirubins, direct and indirect ) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests (glomerular filtration rate) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Neonatal outcomes ( bradycardia) -yes or no(immediately after the use of medication until hospital discharge)
- Neonatal outcomes (comorbidity) -yes or no(immediately after the use of medication until hospital discharge)
- Profile of the following laboratory tests ( urea) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Use of antihypertensive drugs at the time of hospital discharge ( yes or no)(immediately after discharge from the hospital up to 15 days after delivery)
- Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests aspartate transferase (AST)) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests (sodium, potassium and chlorine) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Days of hospital stay after delivery until blood pressure control(number of days (24 hours) from postpartum hospitalization until normalization of blood pressure)
- Need for drug use for hypertensive peak ( yes or no)(every 4 hours immediately after the use of medication until hospital discharge)
- maternal complicatios ( yes or no)(immediately after the use of medication until hospital discharge)
- Postpartum depression(immediately after the use of medication until return for evaluation of the patient 15 days after delivery)
- Profile of the following laboratory tests (DHL) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests (uric acid) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Profile of the following laboratory tests (platelets) on admission and their evolution during the puerperium(the first before delivery and the next every 24 hours after delivery until the normalization of the values)
- Need to associate another hypotensive drug to control blood pressure ( yes or no)(immediately after the use of medication until hospital discharge)
- use of analgesic and anti-inflammatory ( yes or no)(number of doses in 24 hours for postpartum analgesia)
- satisfactory breastfeeding(immediately after the use of medication until hospital discharge)
- Neonatal outcomes ( hypoglycemia) -yes or no(immediately after the use of medication until hospital discharge)
- Neonatal outcomes (hypotension) -yes or no(immediately after the use of medication until hospital discharge)
研究者
Rossana Mariana Carvalho de Paiva Marques
MD
Federal University of Paraíba