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

Phase 4

Completed

• Conditions: Pregnancy-Induced Hypertension in Postpartum; Hypertension; Postpartum Pre-Eclampsia
• Interventions: Drug: Methyldopa 250 MG

• Registration Number: NCT04835233
• Lead Sponsor: Federal University of Paraíba

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.

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 Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2021-05-01
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
captopril	Methyldopa 250 MG	postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum
methyldopa	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

Primary Outcome Measures

Name	Time	Method
Values of heart rate	every 4 hours immediately after the use of medication until hospital discharge	values of heart rate bpm (beat per minute) after starting postpartum medication
Values of blood pressure (dyastolic blood pressure)	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
Frequency of hypertensive peaks	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
Values of blood pressure (systolic blood pressure)	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
Values of blood pressure ( mean arterial pressure)	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

Secondary Outcome Measures

Name	Time	Method
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 on admission and their evolution during the puerperium: creatinine ( blood dosage) measure of value ( mg/dL)
Profile of the following laboratory tests alanine transferase (ALT) 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 on admission and their evolution during the puerperium: alanine transferase (ALT) (blood dosage) measure of value U/L
Frequency of adverse effects most often described with medications ( yes or no)	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
degree of maternal satisfaction with medication	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)
Neonatal outcomes (Hypothermia) -yes or no	immediately after the use of medication until hospital discharge	Hypothermia below 36,5 degree celsius
Profile of the following laboratory tests (total bilirubins, direct and indirect ) 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 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 (glomerular filtration rate) 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 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/
Neonatal outcomes ( bradycardia) -yes or no	immediately after the use of medication until hospital discharge	bradycardia( below 100 beats per minute of the newborn)
Neonatal outcomes (comorbidity) -yes or no	immediately after the use of medication until hospital discharge	Some unfavorable clinical condition of the newborn (comorbidity)
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 on admission and their evolution during the puerperium: urea ( blood dosage) measure of value ( mg/dL)
Use of antihypertensive drugs at the time of hospital discharge ( yes or no)	immediately after discharge from the hospital up to 15 days after delivery	patient was discharged using antihypertensive medication
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 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 aspartate transferase (AST)) 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 on admission and their evolution during the puerperium: aspartate transferase (blood dosage) measure of value U/L
Profile of the following laboratory tests (sodium, potassium and chlorine) 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 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	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)
Need for drug use for hypertensive peak ( yes or no)	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.
maternal complicatios ( yes or no)	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)
Postpartum depression	immediately after the use of medication until return for evaluation of the patient 15 days after delivery	Edinburgh Postpartum Depression Scale (EPDS)
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 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	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
Profile of the following laboratory tests (platelets) 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 on admission and their evolution during the puerperium: platelets/ µL (blood dosage)
Need to associate another hypotensive drug to control blood pressure ( yes or no)	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)
use of analgesic and anti-inflammatory ( yes or no)	number of doses in 24 hours for postpartum analgesia	need for analgesic and anti-inflammatory use and the amount used (number of doses)
satisfactory breastfeeding	immediately after the use of medication until hospital discharge	satisfactory, unsatisfactory and with difficulty reported by the mother
Neonatal outcomes ( hypoglycemia) -yes or no	immediately after the use of medication until hospital discharge	blood glucose below \< 45 mg/dL
Neonatal outcomes (hypotension) -yes or no	immediately after the use of medication until hospital discharge	mean arterial pressure (mmHg) below gestational age (weeks)

Trial Locations

Locations (1)

UFPB Paraíba Federal University; 🇧🇷 João Pessoa, Paraíba, Brazil