Effectiveness of the Use of Methyldopa in Comparison to Captopril in Hypertension Post Partum
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: methyldopa 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
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
|
| Active Comparator: captopril 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
|
Outcome Measures
Primary Outcome Measures
- 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 (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
- 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
- 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
- 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
Secondary Outcome Measures
- 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 ( 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)
- 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 (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 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 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
- 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 (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)
- 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/
- 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.
- 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)
- 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
- 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
- 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)
- satisfactory breastfeeding [immediately after the use of medication until hospital discharge]
satisfactory, unsatisfactory and with difficulty reported by the mother
- 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)
- Postpartum depression [immediately after the use of medication until return for evaluation of the patient 15 days after delivery]
Edinburgh Postpartum Depression Scale (EPDS)
- 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 ( hypoglycemia) -yes or no [immediately after the use of medication until hospital discharge]
blood glucose below < 45 mg/dL
- Neonatal outcomes (Hypothermia) -yes or no [immediately after the use of medication until hospital discharge]
Hypothermia below 36,5 degree celsius
- Neonatal outcomes (comorbidity) -yes or no [immediately after the use of medication until hospital discharge]
Some unfavorable clinical condition of the newborn (comorbidity)
- Neonatal outcomes (hypotension) -yes or no [immediately after the use of medication until hospital discharge]
mean arterial pressure (mmHg) below gestational age (weeks)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UFPB Paraíba Federal University | João Pessoa | Paraíba | Brazil | 58050-585 |
Sponsors and Collaborators
- Federal University of Paraíba
Investigators
- Principal Investigator: Andre Telis Araujo, PhD, Federal University of Paraíba
- Principal Investigator: Luiz Aparecido Bortolotto, PhD, FMUSP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19479