A Phase 4 interventional study of Methyldopa 250 MG in Pregnancy-Induced Hypertension in Postpartum, Postpartum Pre-Eclampsia and Hypertension, sponsored by Federal University of Paraíba. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by Federal University of Paraíba · Phase 4, Interventional, and Treatment
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.
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.
328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.
This study's enrollment of 180 is above the median of 120 across 169 interventional studies indexed under Eclampsia.
Browse Eclampsia studies →Federal University of Paraíba is the lead sponsor of 72 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Values of blood pressure (systolic blood pressure)
systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: every 4 hours immediately after the use of medication until hospital discharge
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.
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 ( 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)
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 (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)
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 (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)
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 (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
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 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
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 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
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 (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
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 (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)
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 (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/
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 (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)
Time frame: 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
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)
Time frame: number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
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.
Time frame: 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)
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)
Time frame: immediately after the use of medication until hospital discharge
use of analgesic and anti-inflammatory ( yes or no)
need for analgesic and anti-inflammatory use and the amount used (number of doses)
Time frame: number of doses in 24 hours for postpartum analgesia
Use of antihypertensive drugs at the time of hospital discharge ( yes or no)
patient was discharged using antihypertensive medication
Time frame: immediately after discharge from the hospital up to 15 days after delivery
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
Time frame: immediately after the use of medication until hospital discharge
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)
Time frame: immediately after the use of medication until hospital discharge
satisfactory breastfeeding
satisfactory, unsatisfactory and with difficulty reported by the mother
Time frame: immediately after the use of medication until hospital discharge
degree of maternal satisfaction with medication
I hated it, I didn't like it, indifferent, I liked it, I loved it (scale of faces)
Time frame: immediately after the use of medication until hospital discharge
Postpartum depression
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: immediately after the use of medication until return for evaluation of the patient 15 days after delivery
Neonatal outcomes ( bradycardia) -yes or no
bradycardia( below 100 beats per minute of the newborn)
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes ( hypoglycemia) -yes or no
blood glucose below \< 45 mg/dL
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (Hypothermia) -yes or no
Hypothermia below 36,5 degree celsius
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (comorbidity) -yes or no
Some unfavorable clinical condition of the newborn (comorbidity)
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (hypotension) -yes or no
mean arterial pressure (mmHg) below gestational age (weeks)
Time frame: immediately after the use of medication until hospital discharge
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of Paraíba