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Completed

NCT Number: NCT04835233

Management of Hypertension in the Early Postpartum: a Randomized Controlled Trial

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.

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Key information

Conditions

Pregnancy-Induced Hypertension in Postpartum Cardiovascular Diseases Hypertension Postpartum Pre-Eclampsia Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UFPB Paraíba Federal University

João Pessoa, Paraíba, 58050-585, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methyldopa 250 MG

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

  10. 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/

  11. 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)

  12. 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)

  13. 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.

  14. 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)

  15. 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)

  16. 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

  17. 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

  18. 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)

  19. satisfactory breastfeeding

    Time frame: immediately after the use of medication until hospital discharge

    satisfactory, unsatisfactory and with difficulty reported by the mother

  20. 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)

  21. 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)

  22. 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)

  23. Neonatal outcomes ( hypoglycemia) -yes or no

    Time frame: immediately after the use of medication until hospital discharge

    blood glucose below < 45 mg/dL

  24. Neonatal outcomes (Hypothermia) -yes or no

    Time frame: immediately after the use of medication until hospital discharge

    Hypothermia below 36,5 degree celsius

  25. 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)

  26. 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)

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

Management of Hypertension in the Early Postpartum Period: Randomized Clinical Trial Comparing Two Antihypertensive Medications

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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