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

NCT04835233 | Completed Phase 4 DMC

• 1 other identifier: 19479
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy-Induced Hypertension in Postpartum; Postpartum Pre-Eclampsia; Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (26)

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

  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

  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

  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

  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

  the first before delivery and the next every 24 hours after delivery until the normalization of the values

Study Arms (2)

methyldopa

EXPERIMENTAL

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

captopril

ACTIVE COMPARATOR

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

Interventions

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

captopril; methyldopa

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

UFPB Paraíba Federal University

João Pessoa, Paraíba, 58050-585, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Methyldopa

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Andre Telis Araujo, PhD

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

• Luiz Aparecido Bortolotto, PhD

  FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 31, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)