PreeclampsiaPhase 4DIPROFENNCT05586373
Ibuprofen vs Dipyrone After C-section in Preeclampsia
A Phase 4 study testing medication 1 and medication 2 in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The goal of this randomized, triple-masked clinical trial is to compare the effectiveness and safety of the use of ibuprofen versus dipyrone for postoperative analgesia in postpartum women with preeclampsia undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- medication 1 and medication 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Oct 2022to 31 May 2023
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Puerperal women from 14 years of age diagnosed with preeclampsia with signs of severity Immediate postoperative period;
- Delivery attended at the Maternity from Instituto de Medicina Integral Prof Fernando Figueira.
Who cannot join
- Acute kidney disease (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/hour for six to 12 hours)
- Chronic kidney disease;
- Diabetes mellitus;
- Collagenoses;
- Sickle cell anemia;
- Patients who presented bleeding in the pre, trans and immediate postpartum periods;
- Antepartum or puerperal sepsis;
- Known contraindications to the use of NSAIDs and dipyrone;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial
The goal of this randomized, triple-masked clinical trial is to compare the effectiveness and safety of the use of ibuprofen versus dipyrone for postoperative analgesia in postpartum women with preeclampsia undergoing cesarean section.
The main question it aims to answer are:
- Postoperative pain is similar;
- The frequency of acute kidney injury is similar.
Researchers will compare one group that will receive dipyrone and the other group that will receive ibuprofen to see if Postoperative pain are different between groups or development of acute kidney injury each group is different.
Read the detailed description
Specific objectives
In postpartum women with preeclampsia undergoing cesarean section randomized to receive treatment with ibuprofen versus dipyrone for postoperative analgesia, compare:
primary outcomes
- Postoperative pain (mild, moderate, severe by visual analogue scale)
- Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/ hour for six to 12 hours). secondary outcomes
- Average reduction of visual analogue scale scores;
2 Reduction of mean scores by algometer;
- Need for rescue analgesic;
- User satisfaction with the Likert scale;
- Basic laboratory tests and their evolution: urea, creatine, uric acid, saline, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and plaque;
- Evolution of blood pressure in the puerperium;
- Number of hypertensive peaks;
- Need for maintenance antihypertensive treatment and number of drugs;
- Allergic reactions;
- Gastrointestinal side effects;
- Time between postoperative and unassisted ambulation;
- Length of hospital stay;
- Compound maternal morbidity (eclampsia, acute weight edema, HELLP, difficulty hypertension, intracranial hemorrhage, renal function control and others);
- Maternal death;
- Costs related to analgesic medications.
The sample is 74 patients randomized into two groups: one group that will receive dipyrone and the other group that will receive ibuprofen. Randomization for the two groups will be performed according to a list of random numbers drawn up for that purpose by an employee who does not be involved with data collection, to ensure confidentiality in the allocation. From this list, sealed envelopes will be prepared, numbered sequentially, with each number, according to the randomization table, corresponding to the patient's group (dipyrone or ibuprofen).
For statistical analysis of the data, the domain statistical program will be used public Epi-info version 7, or higher versions. Tables will be distributed frequency distribution for categorical variables, calculating the mean and standard deviation of quantitative variables. Then, contingency tables will be used to determine the association of the independent variable (Ibuprofen versus dipyrone) with the dependent variables (Biological characteristics, obstetric features, Maternal clinical parameters at admission and during hospitalization, Maternal laboratory tests at the time of admission). For determination of the strength of association will be calculated as a measure of the risk (RR) and its 95% confidence interval. All p values will be two-tailed and in all stages of the analysis will be considered a level of significance 5%.
- Conditions
- Preeclampsia
- Being tested
- medication 1, medication 2
- Keywords
- Preeclampsia, postpartum period, NSAIDs, acute kidney injury, cesarean section, analgesia
- Medical subject headings
- Pre-Eclampsia, Acute Kidney Injury, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication 1Drug
Also called Ibuprofen 400 mg
Ibuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days
medication 2Drug
Also called Dipyrone 1g
Dipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Ibuprofen 400mg 6/6h, oral, maximum 5 days Receives: Drug: medication 1 |
| Group 2 | Experimental | Dipyrone 1g 6/6h, oral, maximum 5 days Receives: Drug: medication 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain (mild, moderate, severe by visual analogue scale)
Measured: from 24 after delivery to 48 hours
Development of acute kidney injury
Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/ hour for six to 12 hours).
Measured: from 24 after delivery to 48 hours
Secondary outcomes (26)
Mean reduction of pain scores by visual analogue scale;
Mean reduction of pain scores by visual analogue scale;
Measured: from 24 after delivery to 48 hours
Mean reduction in pain scores assessed by algometer
Mean reduction in pain scores assessed by algometer
Measured: from 24 after delivery to 48 hours
need for rescue analgesic therapy;
Quantify the number of times analgesic medication was requested, in addition to what is being offered in the study
Measured: from 24 after delivery to 48 hours
User satisfaction level
Likert scale, used in questionnaires, Participants choose from a variety of possible responses to a specific question or statement; responses usually include "strongly agree", "agree", "neutral", "disagree" and "strongly disagree".
Measured: from 24 after delivery to 48 hours
urea dosage
Baseline laboratory tests and their evolution, urea measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
aspartate transferase dosage
Baseline laboratory tests and their evolution, aspartate transferase dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
potassium dosage
Baseline laboratory tests and their evolution, potassium dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
chlorine dosage
Baseline laboratory tests and their evolution,chlorine dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
alanine transferase dosage
Baseline laboratory tests and their evolution, alanine transferase dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
lactic dehydrogenase dosage
Baseline laboratory tests and their evolution, lactic dehydrogenase dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
sodium dosage
Baseline laboratory tests and their evolution, sodium dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
creatinine dosage
Baseline laboratory tests and their evolution, creatinine dosage measured in mg/dl at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
c
Baseline laboratory tests and their evolution, creatinine dosage measured in mm³ at admission and up to 48 hours after admission.
Measured: from admission in the hospital until 48 hours after delivery
total and fractions bilirubin dosage
Baseline laboratory tests and their evolution: urea, creatinine, uric acid, sodium, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and platelets;
Measured: from admission in the hospital until 48 hours after delivery
uric acid dosage
Baseline laboratory test and the evolution. urea, creatinine, uric acid, sodium, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and platelets;
Measured: from admission in the hospital until 48 hours after delivery
Evolution of blood pressure in the puerperium
Evolution of blood pressure in the puerperium
Measured: from 24 after delivery to 48 hours
Number of hypertensive peaks
Number of hypertensive peaks (systolic blood pressure of 180mmHg and/or diastolic blood pressure of 120mmHg);
Measured: from 24 after delivery until discharge of the hospital
need for maintenance antihypertensive treatment
Identify the presence or absence of maintenance antihypertensive drugs
Measured: from 24 after delivery until discharge of the hospital
number of antihypertensive drugs;
quantify how many antihypertensive medications are being used
Measured: from 24 after delivery until discharge of the hospital
Allergic reactions
Questionnaire with options for allergic manifestations: urticaria, angioedema, eczema, asthma.
Measured: from 24 after delivery to 48 hours
Gastrointestinal side effects
Questionnaire with options for acute gastrointestinal effects: abdominal pain, dyspepsia and diarrhea
Measured: from 24 after delivery to 48 hours
Time between postoperative and unassisted ambulation
Time between postoperative and unassisted ambulation
Measured: from 24 after delivery to 48 hours
Length of hospital stay
Length of hospital stay
Measured: From hospital admission to hospital discharge date or up to eight days after surgery whichever comes first.
Compound maternal morbidity
Compound maternal morbidity (eclampsia, acute pulmonary edema, HELLP syndrome, difficult-to-control hypertension, intracranial hemorrhage, renal failure and others);
Measured: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Maternal death
Space reserved in the questionnaire to be described according to the death certificate the primary cause of maternal death.
Measured: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Costs related to analgesic medications
Accounting for the cost related to each dose doses of anesthetic medications that were used in addition to the therapeutic regimens of the experiment were used
Measured: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start15 Oct 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586373
- Sponsor's protocol ID
- DIPROFEN
- Acronym
- DIPROFEN
- Status last verified
- Jun 2023
- First submitted
- 10 Oct 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05586373
- Acronym / sponsor ID
- DIPROFEN / DIPROFEN
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, postpartum period, NSAIDs, acute kidney injury, cesarean section, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Oct 2022 (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.
The goal of this randomized, triple-masked clinical trial is to compare the effectiveness and safety of the use of ibuprofen versus dipyrone for postoperative analgesia in postpartum women with preeclampsia undergoing cesarean section.
The main question it aims to answer are:
- Postoperative pain is similar;
- The frequency of acute kidney injury is similar.
Researchers will compare one group that will receive dipyrone and the other group that will receive ibuprofen to see if Postoperative pain are different between groups or development of acute kidney injury each group is different.
Detailed description
Specific objectives
In postpartum women with preeclampsia undergoing cesarean section randomized to receive treatment with ibuprofen versus dipyrone for postoperative analgesia, compare:
primary outcomes
- Postoperative pain (mild, moderate, severe by visual analogue scale)
- Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/ hour for six to 12 hours). secondary outcomes
- Average reduction of visual analogue scale scores;
2 Reduction of mean scores by algometer;
- Need for rescue analgesic;
- User satisfaction with the Likert scale;
- Basic laboratory tests and their evolution: urea, creatine, uric acid, saline, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and plaque;
- Evolution of blood pressure in the puerperium;
- Number of hypertensive peaks;
- Need for maintenance antihypertensive treatment and number of drugs;
- Allergic reactions;
- Gastrointestinal side effects;
- Time between postoperative and unassisted ambulation;
- Length of hospital stay;
- Compound maternal morbidity (eclampsia, acute weight edema, HELLP, difficulty hypertension, intracranial hemorrhage, renal function control and others);
- Maternal death;
- Costs related to analgesic medications.
The sample is 74 patients randomized into two groups: one group that will receive dipyrone and the other group that will receive ibuprofen. Randomization for the two groups will be performed according to a list of random numbers drawn up for that purpose by an employee who does not be involved with data collection, to ensure confidentiality in the allocation. From this list, sealed envelopes will be prepared, numbered sequentially, with each number, according to the randomization table, corresponding to the patient's group (dipyrone or ibuprofen).
For statistical analysis of the data, the domain statistical program will be used public Epi-info version 7, or higher versions. Tables will be distributed frequency distribution for categorical variables, calculating the mean and standard deviation of quantitative variables. Then, contingency tables will be used to determine the association of the independent variable (Ibuprofen versus dipyrone) with the dependent variables (Biological characteristics, obstetric features, Maternal clinical parameters at admission and during hospitalization, Maternal laboratory tests at the time of admission). For determination of the strength of association will be calculated as a measure of the risk (RR) and its 95% confidence interval. All p values will be two-tailed and in all stages of the analysis will be considered a level of significance 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: medication 1Ibuprofen 400mg 6/6h, oral, maximum 5 days |
| Group 2 | Experimental | Drug: medication 2Dipyrone 1g 6/6h, oral, maximum 5 days |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Puerperal women from 14 years of age diagnosed with preeclampsia with signs of severity Immediate postoperative period;
- Delivery attended at the Maternity from Instituto de Medicina Integral Prof Fernando Figueira.
Key exclusion criteria (8 listed)
- Acute kidney disease (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/hour for six to 12 hours)
- Chronic kidney disease;
- Diabetes mellitus;
- Collagenoses;
- Sickle cell anemia;
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 |
|---|---|---|
| medication 1Also: Ibuprofen 400 mgIbuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days | Drug | Group 1 |
| medication 2Also: Dipyrone 1gDipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days | Drug | Group 2 |
Primary outcome
Postoperative pain
Time frame: from 24 after delivery to 48 hours
Postoperative pain (mild, moderate, severe by visual analogue scale)
Development of acute kidney injury
Time frame: from 24 after delivery to 48 hours
Development of acute kidney injury (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to <0.5 mL/kg/ hour for six to 12 hours).
26 secondary outcomes
Mean reduction of pain scores by visual analogue scale;
Time frame: from 24 after delivery to 48 hours
Mean reduction in pain scores assessed by algometer
Time frame: from 24 after delivery to 48 hours
need for rescue analgesic therapy;
Time frame: from 24 after delivery to 48 hours
User satisfaction level
Time frame: from 24 after delivery to 48 hours
urea dosage
Time frame: from admission in the hospital until 48 hours after delivery
aspartate transferase dosage
Time frame: from admission in the hospital until 48 hours after delivery
potassium dosage
Time frame: from admission in the hospital until 48 hours after delivery
chlorine dosage
Time frame: from admission in the hospital until 48 hours after delivery
alanine transferase dosage
Time frame: from admission in the hospital until 48 hours after delivery
lactic dehydrogenase dosage
Time frame: from admission in the hospital until 48 hours after delivery
sodium dosage
Time frame: from admission in the hospital until 48 hours after delivery
creatinine dosage
Time frame: from admission in the hospital until 48 hours after delivery
c
Time frame: from admission in the hospital until 48 hours after delivery
total and fractions bilirubin dosage
Time frame: from admission in the hospital until 48 hours after delivery
uric acid dosage
Time frame: from admission in the hospital until 48 hours after delivery
Evolution of blood pressure in the puerperium
Time frame: from 24 after delivery to 48 hours
Number of hypertensive peaks
Time frame: from 24 after delivery until discharge of the hospital
need for maintenance antihypertensive treatment
Time frame: from 24 after delivery until discharge of the hospital
number of antihypertensive drugs;
Time frame: from 24 after delivery until discharge of the hospital
Allergic reactions
Time frame: from 24 after delivery to 48 hours
Gastrointestinal side effects
Time frame: from 24 after delivery to 48 hours
Time between postoperative and unassisted ambulation
Time frame: from 24 after delivery to 48 hours
Length of hospital stay
Time frame: From hospital admission to hospital discharge date or up to eight days after surgery whichever comes first.
Compound maternal morbidity
Time frame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Maternal death
Time frame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Costs related to analgesic medications
Time frame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
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 9 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 medication 1 and medication 2 in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira 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 2 inclusion and 8 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 9 Jun 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?
Postoperative pain (time frame: from 24 after delivery to 48 hours). The study lists 2 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 9 Jun 2023.