Hypertension In Postpartum Preeclampsia Study

NCT03011567 | Completed Results DMC

• 1 other identifier: 663-15
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.

Conditions

Hypertension, Pregnancy-Induced

Keywords

Postpartum

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Pain Control During Hospital Stay

  Through study completion, an average of 3 days

• Outpatient Blood Pressure Measurement

  6 weeks after discharge from the hospital

• Patient Satisfaction

  Through study completion, an average of 3 days

• Length of Hospital Stay

  Through study completion, an average of 3 days

• Diuresis

  Through study completion, an average of 3 days

Study Arms (4)

Severe HDP- NSAID

EXPERIMENTAL

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Drug: Ibuprofen

Mild HDP- NSAID

EXPERIMENTAL

This arm will be assigned a postpartum analgesic regimen with ibuprofen.

Drug: Ibuprofen

Severe HDP- No NSAID

EXPERIMENTAL

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Drug: Acetaminophen

Mild HDP- No NSAID

EXPERIMENTAL

This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Participants will receive acetaminophen for postpartum mild pain relief

Also known as: Tylenol

Mild HDP- No NSAID; Severe HDP- No NSAID

Ibuprofen DRUG

Participants will receive ibuprofen for postpartum mild pain relief

Also known as: Motrin

Mild HDP- NSAID; Severe HDP- NSAID

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Miller Children and Women Hospital Long Beach

Long Beach, California, 90806, United States

Location

Related Publications (1)

• 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.

  PMID: 31764732 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Christina Penfield, MD, MPH
• Organization: NYU Langone Health

christina.penfield@gmail.com

646-754-2700

Study Officials

• Jennifer McNulty, MD

  Long Beach Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Can be available on request
• Access Criteria: Can be available on request

Locations

US (1)