Preeclampsia SeverePhase 2PANDANCT03978767
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
A Phase 2 study testing Ibuprofen 600 mg, Ketorolac and Acetaminophen in people with Preeclampsia Severe and Preeclampsia Postpartum, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia Severe, Preeclampsia Postpartum
- What is being tested?
- Ibuprofen 600 mg, Ketorolac and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 15 Jun 2026
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women at > 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
- An antepartum diagnosis of preeclampsia with severe features
- Pre-eclampsia with severe features will be defined as:
- Elevated blood pressure ≥ 160/110, or
- Pre-eclampsia in the setting of thrombocytopenia (platelet count < 100,000), or
- Impaired liver function (AST elevated to twice upper limit of normal), or
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- Persistent epigastric pain, or
- Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or
- Pulmonary edema, or
- New onset visual disturbance or headache unresponsive to therapy.
Who cannot join
- NSAID allergy
- Allergy to acetaminophen
- Antihypertensive use in this pregnancy prior to 20 weeks gestation
- Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
- Inability to obtain consent
- Opioid abuse disorder
- Peptic ulcer disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.
Read the detailed description
Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions.
The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.
- Conditions
- Preeclampsia Severe, Preeclampsia Postpartum
- Being tested
- Ibuprofen 600 mg, Ketorolac, Acetaminophen, Oxycodone
- Keywords
- NSAIDs, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
NSAID pain medication to be used in the experimental bundle for postpartum analgesia
KetorolacDrug
NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section
AcetaminophenDrug
Analgesic medication to be used in both treatment arms
OxycodoneDrug
Analgesic medication to be used in both treatment arms
| Study group | Role | What they receive |
|---|---|---|
| NSAID Analgesic bundle | Experimental | Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery Receives: Drug: Ibuprofen 600 mg; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone |
| NSAID free analgesic bundle | Active comparator | Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. Receives: Drug: Acetaminophen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum antihypertensive requirements
measurement of anti-hypertensive requirements at time of discharge
Measured: at the end of hospitalization, up to 7 days after randomization
Secondary outcomes (6)
Postpartum pain scores
Evaluate the effect of NSAIDs on patient perception of pain
Measured: From randomization to 6 weeks after randomization
Postpartum opioid use
Compare the opioid requirements in each arm
Measured: From randomization to 6 weeks after randomization
Mean arterial blood pressure
Compare peak, average and median MAPs postpartum
Measured: From randomization to 6 weeks after randomization
End organ damage
Evaluate for evidence of renal, hepatic or neurological injury in the poatpartum period
Measured: during hospitalization, an average of 4 days
Hospital readmission
Evaluate the incidence of hospital readmission rate postpartum
Measured: From randomization to 6 weeks after randomization
Continued anti-hypertensive requirement
evaluate the need for antihypertensive medications at 6 weeks postpartum
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start10 Jun 2019
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia SevereStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized non-inferiority clinical trial
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978767
- Sponsor's protocol ID
- 201901202
- Acronym
- PANDA
- Status last verified
- Jun 2026
- First submitted
- 18 May 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5.
PubMed 23403779Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.
PubMed 15733721Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.
PubMed 29045342Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
PubMed 28885417
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
- ClinicalTrials.gov ID
- NCT03978767
- Acronym / sponsor ID
- PANDA / 201901202
- Conditions
- Preeclampsia Severe, Preeclampsia Postpartum
- Keywords
- NSAIDs, Ibuprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 7 Jun 2019 (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.
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.
Detailed description
Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions.
The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized non-inferiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| NSAID Analgesic bundle | Experimental | Drug: Ibuprofen 600 mg, Drug: Ketorolac, Drug: Acetaminophen, Drug: OxycodoneIbuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery |
| NSAID free analgesic bundle | Active comparator | Drug: Acetaminophen, Drug: OxycodoneAcetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Women at > 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
- An antepartum diagnosis of preeclampsia with severe features
- Pre-eclampsia with severe features will be defined as:
- Elevated blood pressure ≥ 160/110, or
- Pre-eclampsia in the setting of thrombocytopenia (platelet count < 100,000), or
Key exclusion criteria (7 listed)
- NSAID allergy
- Allergy to acetaminophen
- Antihypertensive use in this pregnancy prior to 20 weeks gestation
- Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
- Inability to obtain consent
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 |
|---|---|---|
| Ibuprofen 600 mgNSAID pain medication to be used in the experimental bundle for postpartum analgesia | Drug | NSAID Analgesic bundle |
| KetorolacNSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section | Drug | NSAID Analgesic bundle |
| AcetaminophenAnalgesic medication to be used in both treatment arms | Drug | NSAID Analgesic bundle, NSAID free analgesic bundle |
| OxycodoneAnalgesic medication to be used in both treatment arms | Drug | NSAID Analgesic bundle, NSAID free analgesic bundle |
Primary outcome
postpartum antihypertensive requirements
Time frame: at the end of hospitalization, up to 7 days after randomization
measurement of anti-hypertensive requirements at time of discharge
6 secondary outcomes
Postpartum pain scores
Time frame: From randomization to 6 weeks after randomization
Postpartum opioid use
Time frame: From randomization to 6 weeks after randomization
Mean arterial blood pressure
Time frame: From randomization to 6 weeks after randomization
End organ damage
Time frame: during hospitalization, an average of 4 days
Hospital readmission
Time frame: From randomization to 6 weeks after randomization
Continued anti-hypertensive requirement
Time frame: up to 6 weeks
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 22 Jun 2026.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Background: PubMed 23403779Lo JO, Mission JF, Caughey AB. Hypertensive disease of pregnancy and maternal mortality. Curr Opin Obstet Gynecol. 2013 Apr;25(2):124-32. doi: 10.1097/GCO.0b013e32835e0ef5.
- Background: PubMed 15733721Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.
- Background: PubMed 29045342Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.
- Background: PubMed 28885417Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
- 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.
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 2 study testing Ibuprofen 600 mg, Ketorolac and Acetaminophen in people with Preeclampsia Severe and Preeclampsia Postpartum, run by Washington University School of Medicine 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 10 inclusion and 7 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 22 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
postpartum antihypertensive requirements (time frame: at the end of hospitalization, up to 7 days after randomization). 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 NCT03978767, which also lists 5 linked publications.
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 22 Jun 2026.