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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835233
• Other study ID #: 19479
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
Brazil	UFPB Paraíba Federal University	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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/	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	the first before delivery and the next every 24 hours after delivery until the normalization of the values
Secondary	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)	number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
Secondary	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.	every 4 hours immediately after the use of medication until hospital discharge
Secondary	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)	immediately after the use of medication until hospital discharge
Secondary	use of analgesic and anti-inflammatory ( yes or no)	need for analgesic and anti-inflammatory use and the amount used (number of doses)	number of doses in 24 hours for postpartum analgesia
Secondary	Use of antihypertensive drugs at the time of hospital discharge ( yes or no)	patient was discharged using antihypertensive medication	immediately after discharge from the hospital up to 15 days after delivery
Secondary	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	immediately after the use of medication until hospital discharge
Secondary	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)	immediately after the use of medication until hospital discharge
Secondary	satisfactory breastfeeding	satisfactory, unsatisfactory and with difficulty reported by the mother	immediately after the use of medication until hospital discharge
Secondary	degree of maternal satisfaction with medication	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
Secondary	Postpartum depression	Edinburgh Postpartum Depression Scale (EPDS)	immediately after the use of medication until return for evaluation of the patient 15 days after delivery
Secondary	Neonatal outcomes ( bradycardia) -yes or no	bradycardia( below 100 beats per minute of the newborn)	immediately after the use of medication until hospital discharge
Secondary	Neonatal outcomes ( hypoglycemia) -yes or no	blood glucose below < 45 mg/dL	immediately after the use of medication until hospital discharge
Secondary	Neonatal outcomes (Hypothermia) -yes or no	Hypothermia below 36,5 degree celsius	immediately after the use of medication until hospital discharge
Secondary	Neonatal outcomes (comorbidity) -yes or no	Some unfavorable clinical condition of the newborn (comorbidity)	immediately after the use of medication until hospital discharge
Secondary	Neonatal outcomes (hypotension) -yes or no	mean arterial pressure (mmHg) below gestational age (weeks)	immediately after the use of medication until hospital discharge