PreeclampsiaPhase 4NCT03824119
Postpartum NSAIDS and Maternal Hypertension
A Phase 4 study testing Ibuprofen 600 mg and Standard Postpartum Care without NSAIDs in people with Preeclampsia and Gestational Hypertension, run by University of Southern California at 1 site in United States.
Trial summary
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Gestational Hypertension, Superimposed Preeclampsia
- What is being tested?
- Ibuprofen 600 mg and Standard Postpartum Care without NSAIDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 11 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years or older delivering at LAC/USC Hospital
- Delivery occurring at or after 20 weeks gestation
- Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, eclampsia, chronic hypertension
Who cannot join
- HELLP Syndrome
- Renal dysfunction (Serum Creatinine >1.1 in current pregnancy)
- Known liver disease
- Low platelet count (<50,000 during hospital admission)
- Known sensitivity or allergy to ibuprofen or acetaminophen
- Use of therapeutic doses of anticoagulation
- Postpartum hemorrhage requiring blood transfusion
- Neonate with platelet disorder or thrombocytopenia in breastfeeding mother
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
LA County Hospital/University of Southern California
Los Angeles, California, 90033
Elizabeth Sasso, MD, 323-409-3306, elizabeth.sasso@med.usc.edu
About this study
Official title: Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.
This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.
Read the detailed description
The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm).
This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge.
Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record.
A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).
- Conditions
- Preeclampsia, Gestational Hypertension, Superimposed Preeclampsia, Chronic Hypertension in Obstetric Context
- Being tested
- Ibuprofen 600 mg, Standard Postpartum Care without NSAIDs
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Also called Standard Postpartum Care
Standard postpartum care (including administration of NSAIDs)
Standard Postpartum Care without NSAIDsOther
NSAID administration will be withheld from this group.
| Study group | Role | What they receive |
|---|---|---|
| Standard Postpartum Care | Active comparator | Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management. Receives: Drug: Ibuprofen 600 mg |
| Standard Postpartum Care without NSAIDs | Active comparator | Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider. Receives: Other: Standard Postpartum Care without NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with blood pressure elevation
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
Measured: 24 hours postpartum
Secondary outcomes (9)
Proportion of participants with blood pressure elevation
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
Measured: 48, 72 and 96 hours postpartum
Number of participants with eclamptic Seizure
Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia
Measured: Through study completion, up to 6 weeks postpartum
Number of participants with stroke
New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding
Measured: Through study completion, up to 6 weeks postpartum
Initiation of anti-hypertensive medication
Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol)
Measured: Randomization through hospital discharge, an average of 3-7 days
Pain numerical rating scale (NRS) score
Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported
Measured: Randomization through hospital discharge, measured daily, an average of 3-7 days
Number of participants with renal failure
Creatinine >1.1 or doubled
Measured: Through study completion, up to 6 weeks postpartum
Number of participants with pulmonary edema
Evidence of lung infiltrates on chest radiograph or CT scan
Measured: Through study completion, up to 6 weeks postpartum
Number of participants who die
Measured: From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum
Length of hospital stay
Number of days from delivery to hospital discharge
Measured: Through hospital discharge, an average of 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start11 Dec 2018
- Primary completion11 Dec 2022 (estimated)
- Study completion11 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard H. Lee, University of Southern California
- Investigators
- Richard Lee, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824119
- Sponsor's protocol ID
- HS-17-00959
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med. 1993 Feb 22;153(4):477-84.
PubMed 8435027Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994 Aug 15;121(4):289-300. doi: 10.7326/0003-4819-121-4-199408150-00011.
PubMed 8037411Curhan GC, Willett WC, Rosner B, Stampfer MJ. Frequency of analgesic use and risk of hypertension in younger women. Arch Intern Med. 2002 Oct 28;162(19):2204-8. doi: 10.1001/archinte.162.19.2204.
PubMed 12390063Makris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. doi: 10.1016/j.ajog.2003.08.030.
PubMed 14981414Schoenfeld A, Freedman S, Hod M, Ovadia Y. Antagonism of antihypertensive drug therapy in pregnancy by indomethacin? Am J Obstet Gynecol. 1989 Nov;161(5):1204-5. doi: 10.1016/0002-9378(89)90666-2.
PubMed 2589441Wasden SW, Ragsdale ES, Chasen ST, Skupski DW. Impact of non-steroidal anti-inflammatory drugs on hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Oct;4(4):259-63. doi: 10.1016/j.preghy.2014.06.001. Epub 2014 Jul 11.
PubMed 26104814Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
PubMed 28885417Vigil-De Gracia P, Solis V, Ortega N. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1279-1282. doi: 10.1080/14767058.2016.1210599. Epub 2016 Aug 2.
PubMed 27384376Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
PubMed 3769407Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
PubMed 21963308
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
- ClinicalTrials.gov ID
- NCT03824119
- Acronym / sponsor ID
- HS-17-00959
- Conditions
- Preeclampsia, Gestational Hypertension, Superimposed Preeclampsia, Chronic Hypertension in Obstetric Context
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 11 Dec 2022 (estimated)
- Study completion
- 11 Dec 2022 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.
This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.
Detailed description
The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm).
This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge.
Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record.
A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Postpartum Care | Active comparator | Drug: Ibuprofen 600 mgSubjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management. |
| Standard Postpartum Care without NSAIDs | Active comparator | Other: Standard Postpartum Care without NSAIDsSubjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women 18 years or older delivering at LAC/USC Hospital
- Delivery occurring at or after 20 weeks gestation
- Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, eclampsia, chronic hypertension
Key exclusion criteria (8 listed)
- HELLP Syndrome
- Renal dysfunction (Serum Creatinine >1.1 in current pregnancy)
- Known liver disease
- Low platelet count (<50,000 during hospital admission)
- Known sensitivity or allergy to ibuprofen or acetaminophen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600 mgAlso: Standard Postpartum CareStandard postpartum care (including administration of NSAIDs) | Drug | Standard Postpartum Care |
| Standard Postpartum Care without NSAIDsNSAID administration will be withheld from this group. | Other | Standard Postpartum Care without NSAIDs |
Primary outcome
Proportion of participants with blood pressure elevation
Time frame: 24 hours postpartum
Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
9 secondary outcomes
Proportion of participants with blood pressure elevation
Time frame: 48, 72 and 96 hours postpartum
Number of participants with eclamptic Seizure
Time frame: Through study completion, up to 6 weeks postpartum
Number of participants with stroke
Time frame: Through study completion, up to 6 weeks postpartum
Initiation of anti-hypertensive medication
Time frame: Randomization through hospital discharge, an average of 3-7 days
Pain numerical rating scale (NRS) score
Time frame: Randomization through hospital discharge, measured daily, an average of 3-7 days
Number of participants with renal failure
Time frame: Through study completion, up to 6 weeks postpartum
Number of participants with pulmonary edema
Time frame: Through study completion, up to 6 weeks postpartum
Number of participants who die
Time frame: From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum
Length of hospital stay
Time frame: Through hospital discharge, an average of 3-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 8435027Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med. 1993 Feb 22;153(4):477-84.
- Background: PubMed 8037411Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994 Aug 15;121(4):289-300. doi: 10.7326/0003-4819-121-4-199408150-00011.
- Background: PubMed 12390063Curhan GC, Willett WC, Rosner B, Stampfer MJ. Frequency of analgesic use and risk of hypertension in younger women. Arch Intern Med. 2002 Oct 28;162(19):2204-8. doi: 10.1001/archinte.162.19.2204.
- Background: PubMed 14981414Makris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. doi: 10.1016/j.ajog.2003.08.030.
- Background: PubMed 2589441Schoenfeld A, Freedman S, Hod M, Ovadia Y. Antagonism of antihypertensive drug therapy in pregnancy by indomethacin? Am J Obstet Gynecol. 1989 Nov;161(5):1204-5. doi: 10.1016/0002-9378(89)90666-2.
- Background: PubMed 26104814Wasden SW, Ragsdale ES, Chasen ST, Skupski DW. Impact of non-steroidal anti-inflammatory drugs on hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Oct;4(4):259-63. doi: 10.1016/j.preghy.2014.06.001. Epub 2014 Jul 11.
- Background: PubMed 28885417Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
- Background: PubMed 27384376Vigil-De Gracia P, Solis V, Ortega N. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1279-1282. doi: 10.1080/14767058.2016.1210599. Epub 2016 Aug 2.
- Background: PubMed 3769407Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Background: PubMed 21963308Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lee, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 600 mg and Standard Postpartum Care without NSAIDs in people with Preeclampsia and Gestational Hypertension, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Sasso, MD ((323)409-3306, elizabeth.sasso@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with blood pressure elevation (time frame: 24 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824119, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.