Hypertension, Pregnancy-InducedHIPPSNCT03011567
Hypertension In Postpartum Preeclampsia Study
A study testing Acetaminophen and Ibuprofen in people with Hypertension, Pregnancy-Induced, run by MemorialCare Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
- Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
- Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
- Gestational hypertension
- Preeclampsia without severe features
- Preeclampsia with severe features
- Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
- Eclampsia
Who cannot join
- Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
- Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
- Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
- Low platelet count (recorded measurement <50,000 during hospital admission)
- Significant liver dysfunction (AST or ALT >500)
- Known sensitivities to ibuprofen or acetaminophen
- Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
- Postpartum hemorrhage requiring transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Children and Women Hospital Long Beach
Long Beach, California, 90806
About this study
Official title: A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
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.
Read the detailed description
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).
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- Acetaminophen, Ibuprofen
- Keywords
- Postpartum
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Participants will receive acetaminophen for postpartum mild pain relief
IbuprofenDrug
Also called Motrin
Participants will receive ibuprofen for postpartum mild pain relief
| Study group | Role | What they receive |
|---|---|---|
| Severe HDP- NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Receives: Drug: Ibuprofen |
| Mild HDP- NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with ibuprofen. Receives: Drug: Ibuprofen |
| Severe HDP- No NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Receives: Drug: Acetaminophen |
| Mild HDP- No NSAID | Experimental | This arm will be assigned a postpartum analgesic regimen with acetaminophen. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Mean Arterial Blood Pressure- Mild Group
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Measured: 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
Measured: Through study completion, an average of 3 days
Secondary outcomes (6)
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
Measured: Through study completion, an average of 3 days
Outpatient Blood Pressure Measurement
Outpatient postpartum blood pressure measurement (represented in mean arterial pressure (MAP) within 6 weeks after discharge
Measured: 6 weeks after discharge from the hospital
Patient Satisfaction
Number of patients reporting "High level of satisfaction with pain medications"
Measured: Through study completion, an average of 3 days
Length of Hospital Stay
Length of Hospital Stay after delivery
Measured: Through study completion, an average of 3 days
Diuresis
Achievement of average 200ml/hour for 4 consecutive hours
Measured: Through study completion, an average of 3 days
Average Mean Arterial Blood Pressures During Hospital Stay
Measured: Averaged from all blood pressures measured through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2019
- Study completionOct 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer McNulty, MD, Principal investigator, Long Beach Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011567
- Sponsor's protocol ID
- 663-15
- Acronym
- HIPPS
- Status last verified
- Aug 2020
- First submitted
- 2 Jan 2017
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Available on request
Publications
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.
PubMed 31764732
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT03011567
- Acronym / sponsor ID
- HIPPS / 663-15
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe HDP- NSAID | Experimental | Drug: IbuprofenThis arm will be assigned a postpartum analgesic regimen with ibuprofen. |
| Mild HDP- NSAID | Experimental | Drug: IbuprofenThis arm will be assigned a postpartum analgesic regimen with ibuprofen. |
| Severe HDP- No NSAID | Experimental | Drug: AcetaminophenThis arm will be assigned a postpartum analgesic regimen with acetaminophen. |
| Mild HDP- No NSAID | Experimental | Drug: AcetaminophenThis arm will be assigned a postpartum analgesic regimen with acetaminophen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
- Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
- Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
- Gestational hypertension
- Preeclampsia without severe features
Key exclusion criteria (8 listed)
- Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
- Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
- Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
- Low platelet count (recorded measurement <50,000 during hospital admission)
- Significant liver dysfunction (AST or ALT >500)
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: TylenolParticipants will receive acetaminophen for postpartum mild pain relief | Drug | Mild HDP- No NSAID, Severe HDP- No NSAID |
| IbuprofenAlso: MotrinParticipants will receive ibuprofen for postpartum mild pain relief | Drug | Mild HDP- NSAID, Severe HDP- NSAID |
Primary outcome
Average Mean Arterial Blood Pressure- Mild Group
Time frame: Averaged from all blood pressures measured through study completion, an average of 3 days
Primary outcome for Hypertensive disorders of pregnancy-Mild Study Group
Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group
Time frame: Through study completion, an average of 3 days
Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization
6 secondary outcomes
Pain Control During Hospital Stay
Time frame: Through study completion, an average of 3 days
Outpatient Blood Pressure Measurement
Time frame: 6 weeks after discharge from the hospital
Patient Satisfaction
Time frame: Through study completion, an average of 3 days
Length of Hospital Stay
Time frame: Through study completion, an average of 3 days
Diuresis
Time frame: Through study completion, an average of 3 days
Average Mean Arterial Blood Pressures During Hospital Stay
Time frame: Averaged from all blood pressures measured through study completion, an average of 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31764732Penfield 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.
- Individual participant dataSharing planned: Yes. Available on request
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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.
Jennifer McNulty, MD principal investigator
Long Beach Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and Ibuprofen in people with Hypertension, Pregnancy-Induced, run by MemorialCare Health System 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 8 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 3 Jan 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2024). 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?
Average Mean Arterial Blood Pressure- Mild Group (time frame: Averaged from all blood pressures measured through study completion, an average of 3 days). 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?
On the ClinicalTrials.gov record for NCT03011567, which also lists 1 linked publication.
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 3 Jan 2024.