Phase 2
Completed N=118
ToRsemide for pOstpartum HYpertension
Source: ClinicalTrials.gov NCT02813551 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg — 26; 34 Participants
Summary
Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg |
26; 34 | — |
| SECONDARY Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg) |
7; 6 | — |
| SECONDARY Number of Participants Requiring Postpartum Readmission |
3; 1 | — |
| SECONDARY Length of Hospital Stay After Delivery |
68; 54 | — |
| SECONDARY Weight Change |
3.01; 2.08 | — |
| SECONDARY Change in Lower Extremity Edema |
-1.29; -2.9 | — |
| SECONDARY Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) |
8; 11 | — |
| SECONDARY Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels) |
1; 4 | — |
| SECONDARY Number of Participants With Side Effects of Therapy - Decreased Breast Milk |
1; 0 | — |
| SECONDARY Number of Participants With Severe Composite Maternal Morbidity |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Postpartum women at ≥ 18 years of age
- Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:
- Preeclampsia
- Preeclampsia with severe features
- Preeclampsia superimposed to chronic hypertension
Exclusion Criteria
- Chronic hypertension without superimposed preeclampsia
- Gestational hypertension
- Urine output < 30 cc/h at time of randomization
- Heart failure or pulmonary edema
- Hypersensitivity to Torsemide or sulfonylureas
- Hypokalemia (serum potassium < 3 mEq/L)
- Preexisting diuretic use within 24 hours prior to randomization
Data sourced from ClinicalTrials.gov (NCT02813551). 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.