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Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial

NCT ID: NCT03978767

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Preeclampsia Severe Preeclampsia Postpartum

Keywords

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NSAIDs Ibuprofen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized non-inferiority clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NSAID Analgesic bundle

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

Group Type EXPERIMENTAL

Ibuprofen 600 mg

Intervention Type DRUG

NSAID pain medication to be used in the experimental bundle for postpartum analgesia

Ketorolac

Intervention Type DRUG

NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section

Acetaminophen

Intervention Type DRUG

Analgesic medication to be used in both treatment arms

Oxycodone

Intervention Type DRUG

Analgesic medication to be used in both treatment arms

NSAID free analgesic bundle

Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Analgesic medication to be used in both treatment arms

Oxycodone

Intervention Type DRUG

Analgesic medication to be used in both treatment arms

Interventions

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Ibuprofen 600 mg

NSAID pain medication to be used in the experimental bundle for postpartum analgesia

Intervention Type DRUG

Ketorolac

NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section

Intervention Type DRUG

Acetaminophen

Analgesic medication to be used in both treatment arms

Intervention Type DRUG

Oxycodone

Analgesic medication to be used in both treatment arms

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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.

Exclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24150027 (View on PubMed)

Lo 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.

Reference Type BACKGROUND
PMID: 23403779 (View on PubMed)

Sibai 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.

Reference Type BACKGROUND
PMID: 15733721 (View on PubMed)

Mogos 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.

Reference Type BACKGROUND
PMID: 29045342 (View on PubMed)

Viteri 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.

Reference Type BACKGROUND
PMID: 28885417 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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201901202

Identifier Type: -

Identifier Source: org_study_id