Effectiveness of the Use of Methyldopa in Comparison to Captopril in Hypertension Post Partum

Overview

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.

Full Title of Study: “Effectiveness of the Use of Methyldopa in Comparison to Captopril in the Control of Blood Pressure in the Puerperium: Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2022

Interventions

  • Drug: Methyldopa 250 MG
    • 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

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Values of blood pressure (systolic blood pressure)
    • Time Frame: 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 (dyastolic blood pressure)
    • Time Frame: 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
  • Values of blood pressure ( mean arterial pressure)
    • Time Frame: 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
  • Values of heart rate
    • Time Frame: every 4 hours immediately after the use of medication until hospital discharge
    • values of heart rate bpm (beat per minute) after starting postpartum medication
  • Frequency of hypertensive peaks
    • Time Frame: 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

Secondary Measures

  • Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the days of puerperium: urinary protein / creatinine (P / C) ratio (measured in mg / dL). Values greater than 300mg/dL of protein in 24h are indicative of pre-eclampsia.
  • Profile of the following laboratory tests ( urea) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: urea ( blood dosage) measure of value ( mg/dL)
  • Profile of the following laboratory tests (creatinine) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: creatinine ( blood dosage) measure of value ( mg/dL)
  • Profile of the following laboratory tests (DHL) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: lactic dehydrogenase -DHL ( blood dosage) measure of value ( UI/L)
  • Profile of the following laboratory tests (uric acid) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: uric acid (blood dosage) measure of value mg/dL
  • Profile of the following laboratory tests aspartate transferase (AST)) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: aspartate transferase (blood dosage) measure of value U/L
  • Profile of the following laboratory tests alanine transferase (ALT) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: alanine transferase (ALT) (blood dosage) measure of value U/L
  • Profile of the following laboratory tests (total bilirubins, direct and indirect ) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: total bilirubins, direct and indirect (blood dosage)- measure of value U/L
  • Profile of the following laboratory tests (platelets) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: platelets/ µL (blood dosage)
  • Profile of the following laboratory tests (glomerular filtration rate) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: calculated by formula Modification of Diet Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI), obtained by the site: http://mdrd.com/
  • Profile of the following laboratory tests (sodium, potassium and chlorine) on admission and their evolution during the puerperium
    • Time Frame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
    • Profile of the following laboratory tests on admission and their evolution during the puerperium: sodium, potassium and chlorine – measure of value (mEq/L)
  • Days of hospital stay after delivery until blood pressure control
    • Time Frame: number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
    • Days of hospital stay after delivery until blood pressure control (more than 50% of blood pressure measurements less than or equal to 140 x 90 mmHg)
  • Need for drug use for hypertensive peak ( yes or no)
    • Time Frame: every 4 hours immediately after the use of medication until hospital discharge
    • Clonidine was the drug of choice in the study. The hypertensive peak was considered to be greater than or equal to systolic pressure 160 mmHg and / or diastolic pressure greater than or equal to 110 mmHg.
  • Need to associate another hypotensive drug to control blood pressure ( yes or no)
    • Time Frame: immediately after the use of medication until hospital discharge
    • Need to associate another hypotensive drug to control blood pressure until blood pressure control (more than 50% of blood pressure measurements less than or equal to 140 x 90 mmHg)
  • use of analgesic and anti-inflammatory ( yes or no)
    • Time Frame: number of doses in 24 hours for postpartum analgesia
    • need for analgesic and anti-inflammatory use and the amount used (number of doses)
  • Use of antihypertensive drugs at the time of hospital discharge ( yes or no)
    • Time Frame: immediately after discharge from the hospital up to 15 days after delivery
    • patient was discharged using antihypertensive medication
  • Frequency of adverse effects most often described with medications ( yes or no)
    • Time Frame: immediately after the use of medication until hospital discharge
    • numbers of adverse effects most often described with medications: drowsiness, headache, dizziness, orthostatic hypotension, nausea, vomiting, diarrhea, dry mouth, dry cough, skin rashes, itching, arthralgia, skin lesions, dysgeusia, angioedema
  • maternal complicatios ( yes or no)
    • Time Frame: immediately after the use of medication until hospital discharge
    • maternal complications (eclampsia, HELLP syndrome, impending eclampsia, oliguria, puerperal complications and maternal death) and complications related to hypertensive peaks (stroke, acute myocardial infarction and acute lung edema)
  • satisfactory breastfeeding
    • Time Frame: immediately after the use of medication until hospital discharge
    • satisfactory, unsatisfactory and with difficulty reported by the mother
  • degree of maternal satisfaction with medication
    • Time Frame: immediately after the use of medication until hospital discharge
    • I hated it, I didn’t like it, indifferent, I liked it, I loved it (scale of faces)
  • Postpartum depression
    • Time Frame: immediately after the use of medication until return for evaluation of the patient 15 days after delivery
    • Edinburgh Postpartum Depression Scale (EPDS)
  • Neonatal outcomes ( bradycardia) -yes or no
    • Time Frame: immediately after the use of medication until hospital discharge
    • bradycardia( below 100 beats per minute of the newborn)
  • Neonatal outcomes ( hypoglycemia) -yes or no
    • Time Frame: immediately after the use of medication until hospital discharge
    • blood glucose below < 45 mg/dL
  • Neonatal outcomes (Hypothermia) -yes or no
    • Time Frame: immediately after the use of medication until hospital discharge
    • Hypothermia below 36,5 degree celsius
  • Neonatal outcomes (comorbidity) -yes or no
    • Time Frame: immediately after the use of medication until hospital discharge
    • Some unfavorable clinical condition of the newborn (comorbidity)
  • Neonatal outcomes (hypotension) -yes or no
    • Time Frame: immediately after the use of medication until hospital discharge
    • mean arterial pressure (mmHg) below gestational age (weeks)

Participating in This Clinical Trial

Inclusion Criteria

  • puerpera; – hypertensive; – use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery Exclusion Criteria:

  • Use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or Contraindications to the use of captopril or methyldopa

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Paraíba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rossana Mariana Carvalho de Paiva Marques, MD – Federal University of Paraíba
  • Overall Official(s)
    • Andre Telis Araujo, PhD, Principal Investigator, Federal University of Paraíba
    • Luiz Aparecido Bortolotto, PhD, Principal Investigator, FMUSP

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