N/A
N=202
Hypertension In Postpartum Preeclampsia Study
Hypertension, Pregnancy-Induced
Bottom Line
View on ClinicalTrials.gov: NCT03011567 ↗Enrolled (actual)
202
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Average Mean Arterial Blood Pressure- Mild Group — 93; 93 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acetaminophen (Drug); Ibuprofen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MemorialCare Health System
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Mean Arterial Blood Pressure- Mild Group |
93; 93 | — |
| PRIMARY Primary Outcome for Hypertensive Disorders of Pregnancy- Severe Study Group |
27; 29 | — |
| SECONDARY Pain Control During Hospital Stay |
6.1; 6.4; 5.6; 6.0 | — |
| SECONDARY Outpatient Blood Pressure Measurement |
99; 95; 97.8; 102.7 | — |
| SECONDARY Patient Satisfaction |
58; 22; 65; 22 | — |
| SECONDARY Length of Hospital Stay |
4.3; 2.0; 3.7; 1.8 | — |
| SECONDARY Diuresis |
45; 19; 46; 23 | — |
| SECONDARY Average Mean Arterial Blood Pressures During Hospital Stay |
95.7; 95.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03011567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.