Clinical trial NCT04835233: Management of Hypertension in the Early Postpartum: a Randomized Controlled Trial
Official title: Management of Hypertension in the Early Postpartum Period: Randomized Clinical Trial Comparing Two Antihypertensive Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy-Induced Hypertension in Postpartum
Postpartum Pre-Eclampsia
Hypertension
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Values of blood pressure (systolic blood pressure)
timeFrame: every 4 hours immediately after the use of medication until hospital discharge
measure: Values of blood pressure (dyastolic blood pressure)
timeFrame: every 24 hours immediately after the use of medication until hospital discharge
measure: Values of blood pressure ( mean arterial pressure)
timeFrame: every 4 hours immediately after the use of medication until hospital discharge
measure: Values of heart rate
timeFrame: every 4 hours immediately after the use of medication until hospital discharge
measure: Frequency of hypertensive peaks
timeFrame: every 4 hours immediately after the use of medication until hospital discharge
Secondary outcomes:
measure: Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests ( urea) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (creatinine) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (DHL) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (uric acid) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests aspartate transferase (AST)) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests alanine transferase (ALT) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (total bilirubins, direct and indirect ) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (platelets) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (glomerular filtration rate) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Profile of the following laboratory tests (sodium, potassium and chlorine) on admission and their evolution during the puerperium
timeFrame: the first before delivery and the next every 24 hours after delivery until the normalization of the values
measure: Days of hospital stay after delivery until blood pressure control
timeFrame: number of days (24 hours) from postpartum hospitalization until normalization of blood pressure
measure: Need for drug use for hypertensive peak ( yes or no)
timeFrame: every 4 hours immediately after the use of medication until hospital discharge
measure: Need to associate another hypotensive drug to control blood pressure ( yes or no)
timeFrame: immediately after the use of medication until hospital discharge
measure: use of analgesic and anti-inflammatory ( yes or no)
timeFrame: number of doses in 24 hours for postpartum analgesia
measure: Use of antihypertensive drugs at the time of hospital discharge ( yes or no)
timeFrame: immediately after discharge from the hospital up to 15 days after delivery
measure: Frequency of adverse effects most often described with medications ( yes or no)
timeFrame: immediately after the use of medication until hospital discharge
measure: maternal complicatios ( yes or no)
timeFrame: immediately after the use of medication until hospital discharge
measure: satisfactory breastfeeding
timeFrame: immediately after the use of medication until hospital discharge
measure: degree of maternal satisfaction with medication
timeFrame: immediately after the use of medication until hospital discharge
measure: Postpartum depression
timeFrame: immediately after the use of medication until return for evaluation of the patient 15 days after delivery
measure: Neonatal outcomes ( bradycardia) -yes or no
timeFrame: immediately after the use of medication until hospital discharge
measure: Neonatal outcomes ( hypoglycemia) -yes or no
timeFrame: immediately after the use of medication until hospital discharge
measure: Neonatal outcomes (Hypothermia) -yes or no
timeFrame: immediately after the use of medication until hospital discharge
measure: Neonatal outcomes (comorbidity) -yes or no
timeFrame: immediately after the use of medication until hospital discharge
measure: Neonatal outcomes (hypotension) -yes or no
timeFrame: immediately after the use of medication until hospital discharge
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: UFPB Paraíba Federal University
state: Paraíba
Study officials:
affiliation: Federal University of Paraíba
name: Andre Telis Araujo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FMUSP
name: Luiz Aparecido Bortolotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: