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

December 21, 2023 updated by: Rossana Mariana Carvalho de Paiva Marques, Federal University of Paraíba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58050-585
        • UFPB Paraíba Federal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
every 4 hours immediately after the use of medication until hospital discharge
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
every 24 hours immediately after the use of medication until hospital discharge
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
every 4 hours immediately after the use of medication until hospital discharge
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
every 4 hours immediately after the use of medication until hospital discharge
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
every 4 hours immediately after the use of medication until hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
the first before delivery and the next every 24 hours after delivery until the normalization of the values
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)
the first before delivery and the next every 24 hours after delivery until the normalization of the values
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)
the first before delivery and the next every 24 hours after delivery until the normalization of the values
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)
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
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
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
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
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
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
the first before delivery and the next every 24 hours after delivery until the normalization of the values
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
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
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)
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
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/
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
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)
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
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)
number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
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.
every 4 hours immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until hospital discharge
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)
number of doses in 24 hours for postpartum analgesia
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
immediately after discharge from the hospital up to 15 days after delivery
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
immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until hospital discharge
satisfactory breastfeeding
Time Frame: immediately after the use of medication until hospital discharge
satisfactory, unsatisfactory and with difficulty reported by the mother
immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until return for evaluation of the patient 15 days after delivery
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)
immediately after the use of medication until hospital discharge
Neonatal outcomes ( hypoglycemia) -yes or no
Time Frame: immediately after the use of medication until hospital discharge
blood glucose below < 45 mg/dL
immediately after the use of medication until hospital discharge
Neonatal outcomes (Hypothermia) -yes or no
Time Frame: immediately after the use of medication until hospital discharge
Hypothermia below 36,5 degree celsius
immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until hospital discharge
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)
immediately after the use of medication until hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andre Telis Araujo, PhD, Federal University of Paraíba
  • Principal Investigator: Luiz Aparecido Bortolotto, PhD, FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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