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This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.
Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy.
This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe HDP- NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with ibuprofen. |
|
| Mild HDP- NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with ibuprofen. |
|
| Severe HDP- No NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with acetaminophen. |
|
| Mild HDP- No NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with acetaminophen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Participants will receive acetaminophen for postpartum mild pain relief |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Mean Arterial Blood Pressure- Mild Group | Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group | Averaged from all blood pressures measured through study completion, an average of 3 days |
| Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group | Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization | Through study completion, an average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Control During Hospital Stay | Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain | Through study completion, an average of 3 days |
| Outpatient Blood Pressure Measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer McNulty, MD | Long Beach Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller Children and Women Hospital Long Beach | Long Beach | California | 90806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31764732 | Derived | Penfield CA, McNulty JA, Oakes MC, Nageotte MP. Ibuprofen and Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1219-1226. doi: 10.1097/AOG.0000000000003553. |
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Available on request
Can be available on request
Can be available on request
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Hypertensive Disorders of Pregnancy (HDP)- NSAID | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief |
| FG001 | Mild Hypertensive Disorders of Pregnancy (HDP)- NSAID | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief |
| FG002 | Severe Hypertensive Disorders of Pregnancy (HDP)- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief |
| FG003 | Mild Hypertensive Disorders of Pregnancy (HDP)- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe HDP- NSAID | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief |
| BG001 | Mild HDP- NSAID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Average Mean Arterial Blood Pressure- Mild Group | Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group | Posted | Mean | Standard Deviation | mmHg | Averaged from all blood pressures measured through study completion, an average of 3 days |
|
Adverse event data was collected from study enrollment until 6 weeks postpartum.
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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 | Severe HDP- NSAID | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Penfield, MD, MPH | NYU Langone Health | 646-754-2700 | christina.penfield@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 | Oct 13, 2016 | Jan 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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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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| Ibuprofen | Drug | Participants will receive ibuprofen for postpartum mild pain relief |
|
|
Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge |
| 6 weeks after discharge from the hospital |
| Patient Satisfaction | Number of patients reporting "High level of satisfaction with pain medications" | Through study completion, an average of 3 days |
| Length of Hospital Stay | Length of Hospital Stay after delivery | Through study completion, an average of 3 days |
| Diuresis | Achievement of average 200ml/hour for 4 consecutive hours | Through study completion, an average of 3 days |
| Average Mean Arterial Blood Pressures During Hospital Stay | Averaged from all blood pressures measured through study completion, an average of 3 days |
This arm will be assigned a postpartum analgesic regimen with ibuprofen.
Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief
| BG002 | Severe HDP- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief |
| BG003 | Mild HDP- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Mean | Standard Deviation | weeks |
|
|
|
| Primary | Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group | Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization | Posted | Count of Participants | Participants | Through study completion, an average of 3 days |
|
|
|
| Secondary | Pain Control During Hospital Stay | Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay Minimum 0, maximum 10. 10 means the highest level of pain | Posted | Mean | Standard Deviation | score on a scale | Through study completion, an average of 3 days |
|
|
|
| Secondary | Outpatient Blood Pressure Measurement | Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge | There was a large attrition in participants for this outpatient outcome | Posted | Mean | 95% Confidence Interval | mmHg | 6 weeks after discharge from the hospital |
|
|
|
| Secondary | Patient Satisfaction | Number of patients reporting "High level of satisfaction with pain medications" | Posted | Count of Participants | Participants | Through study completion, an average of 3 days |
|
|
|
| Secondary | Length of Hospital Stay | Length of Hospital Stay after delivery | Posted | Median | Inter-Quartile Range | days | Through study completion, an average of 3 days |
|
|
|
| Secondary | Diuresis | Achievement of average 200ml/hour for 4 consecutive hours | Posted | Count of Participants | Participants | Through study completion, an average of 3 days |
|
|
|
| Secondary | Average Mean Arterial Blood Pressures During Hospital Stay | Posted | Mean | Standard Deviation | mmHG | Averaged from all blood pressures measured through study completion, an average of 3 days |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Mild HDP- NSAID | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Ibuprofen: Participants will receive ibuprofen for postpartum mild pain relief | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Severe HDP- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief | 0 | 70 | 0 | 70 | 0 | 70 |
| EG003 | Mild HDP- No NSAID | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief | 0 | 30 | 0 | 30 | 0 | 30 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |