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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Experimental | Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. |
|
| Ibuprofen | Active Comparator | Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug |
|
| |
| Ibuprofen |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe-range Hypertension After Delivery | length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured | duration of postpartum hospitalization (approximately 3-7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization | number of days from delivery until hospital discharge | duration of postpartum hospitalization (approximately 3-7 days) |
| Mean Arterial Pressure Over the Entire Postpartum Hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Izquierdo, MD, MBA | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. Acetaminophen |
| FG001 | Ibuprofen | Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay. Ibuprofen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. Acetaminophen |
| BG001 | Ibuprofen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Severe-range Hypertension After Delivery | length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured | Posted | Mean | 95% Confidence Interval | hours | duration of postpartum hospitalization (approximately 3-7 days) |
|
Duration of postpartum hospitalization, up to 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen | Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay. Acetaminophen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient readmission | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | exacerbation of preeclampsia requiring readmission |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Blue | University of New Mexico, Division of Maternal-Fetal Medicine | 505-272-6309 | nblue1297@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2017 | Mar 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D017359 | HELLP Syndrome |
| D004461 | Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
|
|
computed mean arterial pressure using all measured blood pressures during postpartum hospitalization
| 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.) | 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 | 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 | duration of postpartum hospitalization (approximately 3-7 days) |
| Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg) | duration of postpartum hospitalization (approximately 3-7 days) |
| Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge | duration of postpartum hospitalization (approximately 3-7 days) |
| Number of Scheduled Oral Antihypertensive Agents Required at Discharge | 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 | 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. | 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). | duration of postpartum hospitalization (approximately 3-7 days) |
| Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day | duration of postpartum hospitalization (approximately 3-7 days) |
| Serum Creatinine Trend From Day of Delivery to Day of Discharge | 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 | 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. | 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 | 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 | 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 | duration of postpartum hospitalization (approximately 3-7 days) |
Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay.
Ibuprofen
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| mode of delivery | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| chronic hypertension requiring treatment | Count of Participants | Participants |
|
| need for IV Antihypertensives before delivery | Count of Participants | Participants |
|
|
|
|
| Secondary | Length of Hospitalization | number of days from delivery until hospital discharge | Posted | Mean | Standard Deviation | days | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Mean Arterial Pressure Over the Entire Postpartum Hospitalization | computed mean arterial pressure using all measured blood pressures during postpartum hospitalization | Posted | Mean | Standard Deviation | mmHg | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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.) | Data not collected | Posted | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
| Secondary | 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 | Data not collected | Posted | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg) | Posted | Mean | Standard Deviation | mm Hg | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Number of Scheduled Oral Antihypertensive Agents Required at Discharge | Data not collected | Posted | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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). | Clinical ascertainment of pain level was of low quality and so was not analyzed. | Posted | Mean | Standard Deviation | units on a scale | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day | Posted | Mean | Standard Deviation | morphine equivalents, mg | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | Serum Creatinine Trend From Day of Delivery to Day of Discharge | data not collected | Posted | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
| Secondary | 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 | Data not collected | Posted | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
| Secondary | Composite of Adverse Events | Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis. | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | duration of postpartum hospitalization (approximately 3-7 days) |
|
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | Ibuprofen | Study participants randomized to the ibuprofen group will receive 600mg of ibuprofen orally every 6 hours during their postpartum hospital stay. Ibuprofen | 0 | 50 | 3 | 50 | 0 | 50 |
|
| Acute postpartum elevation of liver function tests | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| postpartum day 2 |
|