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Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after delivery in high-risk women.
Secondary objectives: To evaluate whether oral furosemide administered to high-risk women after delivery can reduce the frequency of postpartum hypertensive episodes, the need for antihypertensive therapy, the risk of postpartum preeclampsia, and the incidence of severe maternal morbidity.
Hypertensive disorders of pregnancy are one of the leading causes of maternal morbidity and mortality worldwide. The majority of clinical research has focused on pregnancy-related hypertension that develops in the antenatal period, while studies of the incidence, risk factors, and prevention of postpartum hypertension are limited. In particular, there is a paucity of data about the clinical entity known as de novo postpartum hypertension, in which women who are normotensive throughout pregnancy and delivery subsequently go on to develop high blood pressure in the immediate to late postpartum period. Of those with postpartum preeclampsia, 33-69% were normotensive antepartum.
Early identification and treatment of antepartum preeclampsia has been shown to decrease some severe maternal outcomes. Conversely, women with de novo postpartum hypertensive disorders remain among the highest risk for severe maternal morbidity due to decreased surveillance and lack of data regarding preventive therapies and interventions. Evidence from multiple randomized controlled trials have demonstrated a benefit in the use of oral loop-diuretics in decreasing postpartum systolic blood pressure, promoting faster normalization of blood pressure, and decreasing the need for antihypertensive therapy in women with an antenatal diagnosis of preeclampsia. Biological plausibility suggests that loop-diuretic therapy may similarly mitigate the normal physiologic mechanism that has been implicated in the pathogenesis of hypertensive complications after delivery in women at risk for de novo postpartum hypertension.
This study is a double-blind randomized placebo-controlled trial of 82 high-risk women to assess whether treatment with oral Lasix (furosemide) after delivery reduces blood pressure at the time of discharge. Women at high risk for de novo postpartum hypertension will be randomized to a five-day course of either 20 mg oral Lasix (furosemide) or placebo once daily initiated after delivery. Women will be monitored through their routine 2-week and 6-week postpartum visits, during which times hypertensive complications and adverse effects of therapy will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lasix (furosemide) | Experimental | Furosemide 20 mg, oral, once daily for 5 days |
|
| Placebo | Placebo Comparator | Identical-appearing placebo, oral, once daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Furosemide 20 mg pill taken daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure (MAP) | Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first) | 24 hours prior to discharge through discharge, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | Time until discharge from the hospital | Randomization through discharge, up to 7 days |
| Rate of de Novo Postpartum Preeclampsia | Number of participants who develop de novo postpartum hypertension. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell S. Miller, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18455140 | Background | Clark SL, Belfort MA, Dildy GA, Herbst MA, Meyers JA, Hankins GD. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. Am J Obstet Gynecol. 2008 Jul;199(1):36.e1-5; discussion 91-2. e7-11. doi: 10.1016/j.ajog.2008.03.007. Epub 2008 May 2. | |
| 30575675 | Background | ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lasix (Furosemide) | Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days |
| FG001 | Placebo | Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data collected and analyzed for 80 of the 82 participants - 2 participants who initially consented to participate in the trial subsequently withdrew prior to discharge from delivery hospitalization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lasix (Furosemide) | Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days |
| BG001 | Placebo | Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Blood Pressure (MAP) | Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first) | Posted | Mean | Standard Deviation | mmHg | 24 hours prior to discharge through discharge, up to 7 days |
|
Up to 6 weeks postpartum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lasix (Furosemide) | Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Miller, MD | Associate Professor of Prenatal Pediatrics at CUIMC | 212-305-3151 | rsm20@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2022 | Apr 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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The study is a randomized controlled clinical trial of 82 women with one or more high-risk factors for de novo postpartum hypertension, randomized to one of two arms: 20 mg PO Lasix (furosemide) daily for 5 days or identical-appearing daily placebo for 5 days.
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Consenting women will be assigned to Lasix (furosemide) or placebo in a 1:1 ratio according to a randomization scheme achieved using a computer generated algorithm. Neither the participant nor the clinical care team will be aware of the allocation arm.
| Placebo | Other | Identical-appearing placebo pill taken daily for 5 days |
|
| Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
| Percent of Recorded Blood Pressures That Are Elevated | Percent of recorded blood pressures that are elevated (>140 systolic OR >90 diastolic). | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
| Rate of Magnesium Sulfate Administration | Number of participants who receive intravenous magnesium sulfate for seizure prophylaxis. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
| Rate of Initiation of Antihypertensives | Number of participants receiving intravenous antihypertensive therapy and initiated on oral hypertensive therapy. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
| Rate of Severe Maternal Morbidity | Number of participants experiencing severe maternal morbidity (e.g. seizure, stroke, Posterior reversible encephalopathy syndrome (PRES), death, etc.) This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
| Rate of Triage or Emergency Department (ED) Presentation/Readmission | Number of participants who experienced triage or ED presentation/readmission for hypertensive-related complaints. This outcome was assessed at 2 weeks postpartum and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 2 weeks postpartum, 6 weeks postpartum |
| Breastfeeding Continuation Rate | Number of participants continuing to breastfeed of those who initiated breastfeeding after delivery. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 2 weeks and 6 weeks postpartum. | 2 weeks postpartum, 6 weeks postpartum |
| 21979459 | Background | Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-1107. doi: 10.1097/AOG.0b013e318231934c. |
| 21740315 | Background | Filetti LC, Imudia AN, Al-Safi Z, Hobson DT, Awonuga AO, Bahado-Singh RO. New onset delayed postpartum preeclampsia: different disorders? J Matern Fetal Neonatal Med. 2012 Jul;25(7):957-60. doi: 10.3109/14767058.2011.601365. Epub 2011 Aug 16. |
| 15167870 | Background | Matthys LA, Coppage KH, Lambers DS, Barton JR, Sibai BM. Delayed postpartum preeclampsia: an experience of 151 cases. Am J Obstet Gynecol. 2004 May;190(5):1464-6. doi: 10.1016/j.ajog.2004.02.037. |
| 15684172 | Background | Sibai BM. Diagnosis, prevention, and management of eclampsia. Obstet Gynecol. 2005 Feb;105(2):402-10. doi: 10.1097/01.AOG.0000152351.13671.99. |
| 8134057 | Background | Lubarsky SL, Barton JR, Friedman SA, Nasreddine S, Ramadan MK, Sibai BM. Late postpartum eclampsia revisited. Obstet Gynecol. 1994 Apr;83(4):502-5. doi: 10.1097/00006250-199404000-00003. |
| 24211478 | Background | Bigelow CA, Pereira GA, Warmsley A, Cohen J, Getrajdman C, Moshier E, Paris J, Bianco A, Factor SH, Stone J. Risk factors for new-onset late postpartum preeclampsia in women without a history of preeclampsia. Am J Obstet Gynecol. 2014 Apr;210(4):338.e1-338.e8. doi: 10.1016/j.ajog.2013.11.004. Epub 2013 Nov 7. |
| 12066093 | Background | Chames MC, Livingston JC, Ivester TS, Barton JR, Sibai BM. Late postpartum eclampsia: a preventable disease? Am J Obstet Gynecol. 2002 Jun;186(6):1174-7. doi: 10.1067/mob.2002.123824. |
| 15625138 | Background | Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66. |
| 27835048 | Background | Veena P, Perivela L, Raghavan SS. Furosemide in postpartum management of severe preeclampsia: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):84-89. doi: 10.1080/10641955.2016.1239735. Epub 2016 Nov 11. |
| Background | Perdigao JL, Lewey J, Hirshberg A, et al. LB 4: Furosemide for Accelerated Recovery of Blood Pressure Postpartum: a randomized placebo controlled trial (FoR BP). American Journal of Obstetrics & Gynecology. 2020;222(1):S759-S760. |
| 8796794 | Background | Atterbury JL, Groome LJ, Hoff C. Blood pressure changes in normotensive women readmitted in the postpartum period with severe preeclampsia/eclampsia. J Matern Fetal Med. 1996 Jul-Aug;5(4):201-5. doi: 10.1002/(SICI)1520-6661(199607/08)5:43.0.CO;2-O. |
| 29703800 | Background | Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time to Discharge | Time until discharge from the hospital | Posted | Mean | Inter-Quartile Range | days | Randomization through discharge, up to 7 days |
|
|
|
| Secondary | Rate of de Novo Postpartum Preeclampsia | Number of participants who develop de novo postpartum hypertension. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Percent of Recorded Blood Pressures That Are Elevated | Percent of recorded blood pressures that are elevated (>140 systolic OR >90 diastolic). | 1 participant in the Placebo Arm withdrew from the study before the Secondary Outcome data was collected. | Posted | Median | Inter-Quartile Range | percent | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Rate of Magnesium Sulfate Administration | Number of participants who receive intravenous magnesium sulfate for seizure prophylaxis. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Rate of Initiation of Antihypertensives | Number of participants receiving intravenous antihypertensive therapy and initiated on oral hypertensive therapy. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Rate of Severe Maternal Morbidity | Number of participants experiencing severe maternal morbidity (e.g. seizure, stroke, Posterior reversible encephalopathy syndrome (PRES), death, etc.) This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Rate of Triage or Emergency Department (ED) Presentation/Readmission | Number of participants who experienced triage or ED presentation/readmission for hypertensive-related complaints. This outcome was assessed at 2 weeks postpartum and 6 weeks postpartum. Data is reported at 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| Secondary | Breastfeeding Continuation Rate | Number of participants continuing to breastfeed of those who initiated breastfeeding after delivery. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 2 weeks and 6 weeks postpartum. | 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected. | Posted | Count of Participants | Participants | 2 weeks postpartum, 6 weeks postpartum |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days | 0 | 40 | 0 | 40 | 0 | 40 |
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| D002318 | Cardiovascular Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| 6 weeks postpartum |
|