Phase 4
Completed N=43
The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Hypertension, Pregnancy-Induced · Pre-eclampsia
Source: ClinicalTrials.gov NCT02891174 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Difference in Systolic Blood Pressure (SBP) — 131.8; 132.0; 129.1; 129.1 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Systolic Blood Pressure (SBP) |
131.8; 132.0; 129.1; 129.1; -2.7; -2.9 | — |
| SECONDARY Change in Self-reported Pain Score 2 Hours After First Intervention |
-0.6; -0.3; -1.1; 1.0; -0.7; -0.6 | 0.59 |
| SECONDARY Mean Pain Score by Nursing Assessment |
2.2; 2.3 | 0.76 |
| SECONDARY Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen |
3; 4; 3; 4.5; 3; 4.5 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- Antepartum women
- Diagnosis of Gestational Hypertension or Pre-eclampsia by blood pressure ≥140 systolic or ≥90 diastolic, on at least 2 measurements ≥ 4 hours apart; with or without proteinuria (urine protein-creatinine ratio ≥0.3 or 24 hour-urine protein ≥300 mg).
- Taking one or fewer oral medications for blood pressure control.
- Singleton gestation.
- English-speaking
Exclusion Criteria
- Allergy to nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen
- More than 1 severe range blood pressure (≥160 systolic or ≥110 diastolic) prior to enrollment.
- Neurologic symptoms attributed to hypertension (headache, visual changes) prior to enrollment.
- Pulmonary edema.
- Elevated AST (>60 international units/L) or ALT (>70 international units/L) prior to enrollment.
- Low platelet count ( 1.1 or double the baseline creatinine if known) prior to enrollment.
- Chronic hypertension defined as hypertension pre-existing pregnancy or diagnosed prior to 20-weeks' gestation.
- Moderate- or severe-persistent asthma.
- Therapeutic anticoagulation.
- Chronic opiate use during the pregnancy (opiate therapy given daily for > 2 weeks).
- Lactose intolerance or allergy due to placebo containing lactose.
- Cesarean delivery.
- Additional anesthesia at time of delivery (spinal anesthesia, sedation) that would change routine pain management.
Data sourced from ClinicalTrials.gov (NCT02891174). 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. Informational only — not medical advice.