Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04835233
Other study ID # 19479
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2022

Study information

Verified date December 2023
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 31, 2022
Est. primary completion date December 16, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Brazil UFPB Paraíba Federal University João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Values of blood pressure (systolic blood pressure) systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication every 4 hours immediately after the use of medication until hospital discharge
Primary Values of blood pressure (dyastolic blood pressure) diastolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication every 24 hours immediately after the use of medication until hospital discharge
Primary Values of blood pressure ( mean arterial pressure) mean blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication every 4 hours immediately after the use of medication until hospital discharge
Primary Values of heart rate values of heart rate bpm (beat per minute) after starting postpartum medication every 4 hours immediately after the use of medication until hospital discharge
Primary Frequency of hypertensive peaks numbers of hypertensive peaks (Systolic Blood Pressure =160 mmHg and / or Diastolic Blood Pressure = 110 mmHg) after starting postpartum medication every 4 hours immediately after the use of medication until hospital discharge
Secondary Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium 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. the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests ( urea) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: urea ( blood dosage) measure of value ( mg/dL) the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (creatinine) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: creatinine ( blood dosage) measure of value ( mg/dL) the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (DHL) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: lactic dehydrogenase -DHL ( blood dosage) measure of value ( UI/L) the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (uric acid) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: uric acid (blood dosage) measure of value mg/dL the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests aspartate transferase (AST)) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: aspartate transferase (blood dosage) measure of value U/L the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests alanine transferase (ALT) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: alanine transferase (ALT) (blood dosage) measure of value U/L the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (total bilirubins, direct and indirect ) on admission and their evolution during the puerperium 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 the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (platelets) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: platelets/ µL (blood dosage) the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (glomerular filtration rate) on admission and their evolution during the puerperium 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/ the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Profile of the following laboratory tests (sodium, potassium and chlorine) on admission and their evolution during the puerperium Profile of the following laboratory tests on admission and their evolution during the puerperium: sodium, potassium and chlorine - measure of value (mEq/L) the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary Days of hospital stay after delivery until blood pressure control 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) number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
Secondary Need for drug use for hypertensive peak ( yes or no) 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. every 4 hours immediately after the use of medication until hospital discharge
Secondary Need to associate another hypotensive drug to control blood pressure ( yes or no) 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) immediately after the use of medication until hospital discharge
Secondary use of analgesic and anti-inflammatory ( yes or no) need for analgesic and anti-inflammatory use and the amount used (number of doses) number of doses in 24 hours for postpartum analgesia
Secondary Use of antihypertensive drugs at the time of hospital discharge ( yes or no) patient was discharged using antihypertensive medication immediately after discharge from the hospital up to 15 days after delivery
Secondary Frequency of adverse effects most often described with medications ( yes or no) 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 immediately after the use of medication until hospital discharge
Secondary maternal complicatios ( yes or no) 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) immediately after the use of medication until hospital discharge
Secondary satisfactory breastfeeding satisfactory, unsatisfactory and with difficulty reported by the mother immediately after the use of medication until hospital discharge
Secondary degree of maternal satisfaction with medication I hated it, I didn't like it, indifferent, I liked it, I loved it (scale of faces) immediately after the use of medication until hospital discharge
Secondary Postpartum depression Edinburgh Postpartum Depression Scale (EPDS) immediately after the use of medication until return for evaluation of the patient 15 days after delivery
Secondary Neonatal outcomes ( bradycardia) -yes or no bradycardia( below 100 beats per minute of the newborn) immediately after the use of medication until hospital discharge
Secondary Neonatal outcomes ( hypoglycemia) -yes or no blood glucose below < 45 mg/dL immediately after the use of medication until hospital discharge
Secondary Neonatal outcomes (Hypothermia) -yes or no Hypothermia below 36,5 degree celsius immediately after the use of medication until hospital discharge
Secondary Neonatal outcomes (comorbidity) -yes or no Some unfavorable clinical condition of the newborn (comorbidity) immediately after the use of medication until hospital discharge
Secondary Neonatal outcomes (hypotension) -yes or no mean arterial pressure (mmHg) below gestational age (weeks) immediately after the use of medication until hospital discharge
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A