Pre-EclampsiaPhase 4NCT02911701
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Pre-Eclampsia and HELLP Syndrome, run by University of New Mexico at 1 site in United States.
Trial summary
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, HELLP Syndrome, Eclampsia
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 10 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ability to give informed consent
- diagnosis of a "severe" hypertensive disorder of pregnancy:
- preeclampsia with severe features
- chronic hypertension with superimposed preeclampsia with severe features
- HELLP syndrome: hemolysis, elevated liver function tests, low platelets
- eclampsia
- not yet delivered or less than 6 hours after delivery
Who cannot join
- current incarceration
- serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
- AST (aspartate aminotransferase) >200 unit/L
- ALT (alanine aminotransferase) > 200 unit/L
- known allergy or sensitivity to NSAIDs or acetaminophen
- delivery > 6 hours prior to enrollment
Show all 15Show fewer
- chronic kidney disease
- chronic liver disease
- prior liver transplant
- chronic infectious hepatitis
- gastritis
- gastro-esophageal reflux disease (GERD)
- peptic ulcer disease
- bleeding disorder
- provider feels that participation is not in the best interest of the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico
About this study
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.
Read the detailed description
The proposed study is a randomized, controlled, double-masked trial comparing the effect of postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study participants will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain control. Study participants, study personnel and providers will be blinded to randomization status of study participants.
Potential study participants will be enrolled when they are diagnosed with a severe hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features will also be approached and enrolled at the time of diagnosis in anticipation for possible progression to preeclampsia with severe features. Once enrolled, study participants will not be randomized until delivery, at which time they will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available oxycodone for moderate to severe pain, per our routine. Study group allocation will only be known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear identical to each other and will be unmarked through encapsulation. Block randomization will be used to ensure equal allocation to the two study arms.
For the duration of study participation, study participants will undergo postpartum monitoring with vital sign measurements (including blood pressure) every 4 hours, pain assessment with each administration of study medication, as well as daily evaluation of laboratory studies until they have normalized to the satisfaction of their provider. Study participants will receive the study drug every 6 hours from the time of delivery until hospital discharge, unless they refuse. Study participation will be complete upon hospital discharge. Study participants will be contacted by a study team member 6 weeks after delivery to ask about any additional complications or symptoms requiring visits to the emergency department or hospital readmission. Descriptive factors and clinical outcomes will be extracted from the medical record and de-identified by study personnel during each day of study participation.
- Conditions
- Pre-Eclampsia, HELLP Syndrome, Eclampsia
- Being tested
- Acetaminophen, Ibuprofen
- Medical subject headings
- Pre-Eclampsia, HELLP Syndrome, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
IbuprofenDrug
Also called Motrin
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Experimental | Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. Receives: Drug: Acetaminophen |
| Ibuprofen | Active comparator | Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Severe-range Hypertension After Delivery
length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Secondary outcomes (18)
Length of Hospitalization
number of days from delivery until hospital discharge
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Arterial Pressure Over the Entire Postpartum Hospitalization
computed mean arterial pressure using all measured blood pressures during postpartum hospitalization
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Arterial Pressure, Stratified by Postpartum Day 1, 2, 3, Etc.
computed mean arterial pressure using all measured blood pressures during postpartum hospitalization, stratified by postpartum day (1, 2, 3, etc.)
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Total Number of Severe Range Blood Pressure Measurements in Each Study Arm.
mean total number of severe range blood pressure (defined as SBP >160mmGh or DBP >110mmHg) measurements in each study arm
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs
Severe-range hypertension (defined as SBP > 160 mmHg or DBP >1100 mmHg) during postpartum stay
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Number of Scheduled Oral Antihypertensive Agents Required at Discharge
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure
Proportion in each arm who required one or more doses of antihypertensive medication given for acute lowering of BP
Measured: duration of postpartum hospitalization (approximately 3-7 days)
The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives
The proportion of study participants in each study arm who require any IV antihypertensives to acutely lower blood pressure during their postpartum hospital stay.
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day
Mean daily pain level, as reported by patient on scale from 1-10 (10 is most severe).
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Serum Creatinine Trend From Day of Delivery to Day of Discharge
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Mean Drop in Hematocrit From Pre-delivery to the Nadir Prior to Discharge
Mean difference in hematocrit from pre-delivery to postpartum nadir prior to discharge
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Composite of Adverse Events
Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis.
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit
AST: Aspartate aminotransferase; ALT: alanine aminotransferase
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury
Acute kidney injury is defined as serum creatinine > 1.1mg/dL or double the baseline value
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage
Delayed postpartum hemorrhage is defined as > 1000 mL of blood loss occuring > 24 hours after delivery
Measured: duration of postpartum hospitalization (approximately 3-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion7 Nov 2017
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-EclampsiaStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Izquierdo, University of New Mexico
- Investigators
- Luis Izquierdo, MD, MBA, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911701
- Sponsor's protocol ID
- 16-147
- Status last verified
- Jul 2023
- First submitted
- 9 Sep 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
- ClinicalTrials.gov ID
- NCT02911701
- Acronym / sponsor ID
- 16-147
- Conditions
- Pre-Eclampsia, HELLP Syndrome, Eclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the setting of preeclampsia have not been well studied. This study aims to assess the effect of avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with preeclampsia with severe features. Eligible women will be randomized to receive either acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies for pain control although ibuprofen has better pain control than acetaminophen. The primary outcome will be duration of postpartum severe-range hypertension.
Detailed description
The proposed study is a randomized, controlled, double-masked trial comparing the effect of postpartum acetaminophen and ibuprofen on blood pressure among women with preeclampsia. Study participants will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain control. Study participants, study personnel and providers will be blinded to randomization status of study participants.
Potential study participants will be enrolled when they are diagnosed with a severe hypertensive disorder of pregnancy. This will usually occur prior to delivery, but may occur up to 6 hours after delivery. Patients diagnosed with preeclampsia without severe features will also be approached and enrolled at the time of diagnosis in anticipation for possible progression to preeclampsia with severe features. Once enrolled, study participants will not be randomized until delivery, at which time they will be randomized to receive either acetaminophen or ibuprofen for mild postpartum pain. Both groups will have available oxycodone for moderate to severe pain, per our routine. Study group allocation will only be known by the investigational pharmacy. The ibuprofen and acetaminophen will be made to appear identical to each other and will be unmarked through encapsulation. Block randomization will be used to ensure equal allocation to the two study arms.
For the duration of study participation, study participants will undergo postpartum monitoring with vital sign measurements (including blood pressure) every 4 hours, pain assessment with each administration of study medication, as well as daily evaluation of laboratory studies until they have normalized to the satisfaction of their provider. Study participants will receive the study drug every 6 hours from the time of delivery until hospital discharge, unless they refuse. Study participation will be complete upon hospital discharge. Study participants will be contacted by a study team member 6 weeks after delivery to ask about any additional complications or symptoms requiring visits to the emergency department or hospital readmission. Descriptive factors and clinical outcomes will be extracted from the medical record and de-identified by study personnel during each day of study participation.
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 |
|---|---|---|
| Acetaminophen | Experimental | Drug: AcetaminophenStudy participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. |
| Ibuprofen | Active comparator | Drug: IbuprofenStudy participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ability to give informed consent
- diagnosis of a "severe" hypertensive disorder of pregnancy:
- preeclampsia with severe features
- chronic hypertension with superimposed preeclampsia with severe features
- HELLP syndrome: hemolysis, elevated liver function tests, low platelets
Key exclusion criteria (15 listed)
- current incarceration
- serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
- AST (aspartate aminotransferase) >200 unit/L
- ALT (alanine aminotransferase) > 200 unit/L
- known allergy or sensitivity to NSAIDs or acetaminophen
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 |
|---|---|---|
| AcetaminophenAlso: Tylenol | Drug | Acetaminophen |
| IbuprofenAlso: Motrin | Drug | Ibuprofen |
Primary outcome
Duration of Severe-range Hypertension After Delivery
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured
18 secondary outcomes
Length of Hospitalization
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Arterial Pressure Over the Entire Postpartum Hospitalization
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Arterial Pressure, Stratified by Postpartum Day 1, 2, 3, Etc.
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Total Number of Severe Range Blood Pressure Measurements in Each Study Arm.
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Number of Scheduled Oral Antihypertensive Agents Required at Discharge
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Serum Creatinine Trend From Day of Delivery to Day of Discharge
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Mean Drop in Hematocrit From Pre-delivery to the Nadir Prior to Discharge
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Composite of Adverse Events
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage
Time frame: duration of postpartum hospitalization (approximately 3-7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Luis Izquierdo, MD, MBA principal investigator
University of New Mexico
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 Acetaminophen and Ibuprofen in people with Pre-Eclampsia and HELLP Syndrome, run by University of New Mexico at 1 site in United States.
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 7 inclusion and 15 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 27 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Severe-range Hypertension After Delivery (time frame: duration of postpartum hospitalization (approximately 3-7 days)). 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 27 Jul 2023.