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

Federal University of Paraíba

Status and phase: Completed; Phase 4

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

Treatments: Drug: Methyldopa 250 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04835233

19479

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

methyldopa

Experimental group

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

Treatment:

Drug: Methyldopa 250 MG

captopril

Active Comparator group

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

Treatment:

Drug: Methyldopa 250 MG