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

Primary Purpose

Postpartum Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Methyldopa 250 MG

About this trial

This is an interventional treatment trial for Postpartum Hypertension

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

UFPB Paraíba Federal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

methyldopa

captopril

Arm Description

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

postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum

Outcomes

Primary Outcome Measures

Values of blood pressure (systolic blood pressure)

systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Values of blood pressure (dyastolic blood pressure)

diastolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Values of blood pressure ( mean arterial pressure)

mean blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Values of heart rate

values of heart rate bpm (beat per minute) after starting postpartum medication

Frequency of hypertensive peaks

numbers of hypertensive peaks (Systolic Blood Pressure ≥160 mmHg and / or Diastolic Blood Pressure ≥ 110 mmHg) after starting postpartum medication

Secondary Outcome Measures

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.

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)

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)

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)

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

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

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

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

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)

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/

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)

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)

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.

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)

use of analgesic and anti-inflammatory ( yes or no)

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)

patient was discharged using antihypertensive medication

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

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)

satisfactory breastfeeding

satisfactory, unsatisfactory and with difficulty reported by the mother

degree of maternal satisfaction with medication

I hated it, I didn't like it, indifferent, I liked it, I loved it (scale of faces)

Postpartum depression

Edinburgh Postpartum Depression Scale (EPDS)

Neonatal outcomes ( bradycardia) -yes or no

bradycardia( below 100 beats per minute of the newborn)

Neonatal outcomes ( hypoglycemia) -yes or no

blood glucose below < 45 mg/dL

Neonatal outcomes (Hypothermia) -yes or no

Hypothermia below 36,5 degree celsius

Neonatal outcomes (comorbidity) -yes or no

Some unfavorable clinical condition of the newborn (comorbidity)

Neonatal outcomes (hypotension) -yes or no

mean arterial pressure (mmHg) below gestational age (weeks)

Full Information

NCT ID

NCT04835233

First Posted

March 31, 2021

Last Updated

April 5, 2021

Sponsor

Federal University of Paraíba

1. Study Identification

Unique Protocol Identification Number

NCT04835233

Brief Title

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

Official Title

Effectiveness of the Use of Methyldopa in Comparison to Captopril in the Control of Blood Pressure in the Puerperium: Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

methyldopa

Arm Type

Experimental

Arm Description

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

Arm Title

captopril

Arm Type

Active Comparator

Arm Description

postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum

Intervention Type

Drug

Intervention Name(s)

Methyldopa 250 MG

Intervention Description

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 Outcome Measure Information:

Title

Values of blood pressure (systolic blood pressure)

Description

systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Time Frame

every 4 hours immediately after the use of medication until hospital discharge

Title

Values of blood pressure (dyastolic blood pressure)

Description

diastolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Time Frame

every 24 hours immediately after the use of medication until hospital discharge

Title

Values of blood pressure ( mean arterial pressure)

Description

mean blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication

Time Frame

every 4 hours immediately after the use of medication until hospital discharge

Title

Values of heart rate

Description

values of heart rate bpm (beat per minute) after starting postpartum medication

Time Frame

every 4 hours immediately after the use of medication until hospital discharge

Title

Frequency of hypertensive peaks

Description

numbers of hypertensive peaks (Systolic Blood Pressure ≥160 mmHg and / or Diastolic Blood Pressure ≥ 110 mmHg) after starting postpartum medication

Time Frame

every 4 hours immediately after the use of medication until hospital discharge

Secondary Outcome Measure Information:

Title

Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium

Description

Time Frame