Pregnancy-Induced Hypertension in PostpartumPhase 4NCT04835233
Management of Hypertension in the Early Postpartum: a Randomized Controlled Trial
A Phase 4 study testing Methyldopa 250 MG in people with Pregnancy-Induced Hypertension in Postpartum and Postpartum Pre-Eclampsia, run by Federal University of Paraíba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy-Induced Hypertension in Postpartum, Postpartum Pre-Eclampsia, Hypertension
- What is being tested?
- Methyldopa 250 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- puerpera;
- hypertensive;
- use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery
Who cannot join
- Use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or Contraindications to the use of captopril or methyldopa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Hypertension in the Early Postpartum Period: Randomized Clinical Trial Comparing Two Antihypertensive Medications
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.
Read the 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.
- Being tested
- Methyldopa 250 MG
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyldopa 250 MGDrug
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
| Study group | Role | What they receive |
|---|---|---|
| methyldopa | Experimental | 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 Receives: Drug: Methyldopa 250 MG |
| captopril | Active comparator | postpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum Receives: Drug: Methyldopa 250 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of blood pressure (systolic blood pressure)
systolic blood pressure values in mmHg (millimeters of mercury) after starting postpartum medication
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: every 4 hours immediately after the use of medication until hospital discharge
Secondary outcomes (26)
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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/
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: immediately after the use of medication until hospital discharge
satisfactory breastfeeding
satisfactory, unsatisfactory and with difficulty reported by the mother
Measured: 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)
Measured: immediately after the use of medication until hospital discharge
Postpartum depression
Edinburgh Postpartum Depression Scale (EPDS)
Measured: 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)
Measured: immediately after the use of medication until hospital discharge
Neonatal outcomes ( hypoglycemia) -yes or no
blood glucose below < 45 mg/dL
Measured: immediately after the use of medication until hospital discharge
Neonatal outcomes (Hypothermia) -yes or no
Hypothermia below 36,5 degree celsius
Measured: immediately after the use of medication until hospital discharge
Neonatal outcomes (comorbidity) -yes or no
Some unfavorable clinical condition of the newborn (comorbidity)
Measured: immediately after the use of medication until hospital discharge
Neonatal outcomes (hypotension) -yes or no
mean arterial pressure (mmHg) below gestational age (weeks)
Measured: immediately after the use of medication until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion16 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-Induced Hypertension in PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Mariana Carvalho de Paiva Marques, Federal University of Paraíba
- Investigators
- Andre Telis Araujo, PhD, Principal investigator, Federal University of ParaíbaLuiz Aparecido Bortolotto, PhD, Principal investigator, FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835233
- Sponsor's protocol ID
- 19479
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hypertension in the Early Postpartum Period: Randomized Clinical Trial Comparing Two Antihypertensive Medications
- ClinicalTrials.gov ID
- NCT04835233
- Acronym / sponsor ID
- 19479
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methyldopa | Experimental | Drug: Methyldopa 250 MGmaintaining 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 |
| captopril | Active comparator | Drug: Methyldopa 250 MGpostpartum exchange methyldopa for captopril 25 mg 01 tablet every 8 hours, doubling the dose depending on pressure levels, up to 15 days postpartum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- puerpera;
- hypertensive;
- use of methyldopa during pregnancy at a minimum dose of 750 mg / day, for at least 07 days before delivery
Key exclusion criteria (1 listed)
- Use of other antihypertensive medications or illicit drugs that may interfere with maternal hemodynamics, and / or Contraindications to the use of captopril or methyldopa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methyldopa 250 MGmaintaining 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 | captopril, methyldopa |
Primary outcome
Values of blood pressure (systolic blood pressure)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
26 secondary outcomes
Profile of the following laboratory tests ( protein urinary) on admission and their evolution during the puerperium
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
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
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
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
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
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
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
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
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
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
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
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)
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)
Time frame: immediately after the use of medication until hospital discharge
use of analgesic and anti-inflammatory ( yes or no)
Time frame: number of doses in 24 hours for postpartum analgesia
Use of antihypertensive drugs at the time of hospital discharge ( yes or no)
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)
Time frame: immediately after the use of medication until hospital discharge
maternal complicatios ( yes or no)
Time frame: immediately after the use of medication until hospital discharge
satisfactory breastfeeding
Time frame: immediately after the use of medication until hospital discharge
degree of maternal satisfaction with medication
Time frame: immediately after the use of medication until hospital discharge
Postpartum depression
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
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes ( hypoglycemia) -yes or no
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (Hypothermia) -yes or no
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (comorbidity) -yes or no
Time frame: immediately after the use of medication until hospital discharge
Neonatal outcomes (hypotension) -yes or no
Time frame: immediately after the use of medication until hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Telis Araujo, PhD principal investigator
Federal University of Paraíba
Luiz Aparecido Bortolotto, PhD principal investigator
FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methyldopa 250 MG in people with Pregnancy-Induced Hypertension in Postpartum and Postpartum Pre-Eclampsia, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of blood pressure (systolic blood pressure) (time frame: every 4 hours immediately after the use of medication until hospital discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.