Pre-Eclampsia; Complicating PregnancyNCT06920563
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
A study testing Video, Text Reminder and Blood pressure threshold in people with Pre-Eclampsia; Complicating Pregnancy and Gestational Hypertension, run by Ochsner Health System at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are: Is a structured postpartum remote blood pressure monitoring intervention with education and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia; Complicating Pregnancy, Gestational Hypertension
- What is being tested?
- Video, Text Reminder and Blood pressure threshold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 16 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 years.
- Postpartum status.
- Experience new-onset hypertension during pregnancy.
- Enrollment in Connected MOM.
- Ability to provide informed consent.
- Establish medical care within the Ochsner System to facilitate data collection.
Who cannot join
- History of preeclampsia or gestational hypertension during previous pregnancy
- History of chronic hypertension
- History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
- History of ischemic CVA
- History of Congestive heart failure
- Renal dysfunction
Show all 10Show fewer
- Liver dysfunction
- Left ventricular dysfunction
- Congenital heart disease
- Still birth at delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ochsner Baptist
New Orleans, Louisiana, 70115
Ken Bode, +1 (504) 842-1936, ken.bode@ochsner.org
Salima Qamruddin
About this study
Official title: Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education to Reduce Emergency Department Visits, Re-admissions and Adverse Cardiovascular Outcomes in Hypertensive Disorder of Pregnancy
The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are:
Is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? Does a structured program reduce the occurrence of postpartum hypertension, ED visits, hospital readmissions, and adverse outcomes?
Read more
Participants will:
View an educational video on HDP post-delivery Receive 1-2 times daily text messages for 6 weeks postpartum Have their blood pressure medications adjusted to lower targets post partum
- Being tested
- Video, Text Reminder, Blood pressure threshold
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
Those in the intervention arm will watch a short educational video.
Text ReminderOther
Those in the intervention group will receive regular text message reminders to check their blood pressures
Blood pressure thresholdOther
Those in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will watch an education video, receive text message updates, and have their blood pressure medications titrated to a lower BP goal. Receives: Other: Video; Other: Text Reminder; Other: Blood pressure threshold |
| Control | No intervention | This group will receive usual post partum care from their obstetrician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Engagement will be defined by frequency of use: number of remote BP measurements ascertained during the 6 week postpartum period.
Measured: 6 weeks
Acceptability
Post program survey questions using 5-item Likert response scale at 6 weeks postpartum
Measured: 6 weeks
Duration of Participation
Duration of participation is defined by the last day of recorded remote BP measurement
Measured: 6 weeks
Secondary outcomes (5)
Post partum Blood pressure
Proportion of patients with BP <130/80 at 6 weeks Mean SBP, DBP at 6 weeks, 6 months, 1 year postpartum
Measured: 1 year
Number of ED visits
Number of ED visits recorded after discharge from her delivery encounter over the following year.
Measured: 1 year
Severe Maternal Morbidity
Incidence of death, postpartum stroke, congestive heart failure, myocardial infarction, eclampsia
Measured: 1 year
Number of Inpatient re-admissions
Number of inpatient re-admissions over the following year after discharge from delivery encounter
Measured: 1 year
Post partum visit follow up
Proportion of 4-6 week postpartum follow up visit attendance with OB provider
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start17 Mar 2025
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pre-Eclampsia; Complicating PregnancyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920563
- Sponsor's protocol ID
- 2023.192
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mitro SD, Hedderson M, Xu F, Forquer H, Baker JM, Kuzniewicz MW, Greenberg M. Risk of postpartum readmission after hypertensive disorder of pregnancy and variation by discharge antihypertensive medication prescription. Am J Obstet Gynecol. 2024 Oct;231(4):456.e1-456.e13. doi: 10.1016/j.ajog.2024.01.015. Epub 2024 Jan 25.
PubMed 38280432SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
PubMed 26551272Cairns AE, Tucker KL, Leeson P, Mackillop LH, Santos M, Velardo C, Salvi D, Mort S, Mollison J, Tarassenko L, McManus RJ; SNAP-HT Investigators. Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Hypertension. 2018 Aug;72(2):425-432. doi: 10.1161/HYPERTENSIONAHA.118.10911. Epub 2018 Jul 2.
PubMed 29967037Kitt JA, Fox RL, Cairns AE, Mollison J, Burchert HH, Kenworthy Y, McCourt A, Suriano K, Lewandowski AJ, Mackillop L, Tucker KL, McManus RJ, Leeson P. Short-Term Postpartum Blood Pressure Self-Management and Long-Term Blood Pressure Control: A Randomized Controlled Trial. Hypertension. 2021 Aug;78(2):469-479. doi: 10.1161/HYPERTENSIONAHA.120.17101. Epub 2021 Jun 28.
PubMed 34176288Hauspurg A, Lemon LS, Quinn BA, Binstock A, Larkin J, Beigi RH, Watson AR, Simhan HN. A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level. Obstet Gynecol. 2019 Oct;134(4):685-691. doi: 10.1097/AOG.0000000000003479.
PubMed 31503166Mujic E, Parker SE, Nelson KP, O'Brien M, Chestnut IA, Abrams J, Yarrington CD. Implementation of a Cell-Enabled Remote Blood Pressure Monitoring Program During the Postpartum Period at a Safety-Net Hospital. J Am Heart Assoc. 2024 Jul 2;13(13):e034031. doi: 10.1161/JAHA.123.034031. Epub 2024 Jun 27.
PubMed 38934890Bateman BT, Schumacher HC, Bushnell CD, Pile-Spellman J, Simpson LL, Sacco RL, Berman MF. Intracerebral hemorrhage in pregnancy: frequency, risk factors, and outcome. Neurology. 2006 Aug 8;67(3):424-9. doi: 10.1212/01.wnl.0000228277.84760.a2.
PubMed 16894102Jeng JS, Tang SC, Yip PK. Stroke in women of reproductive age: comparison between stroke related and unrelated to pregnancy. J Neurol Sci. 2004 Jun 15;221(1-2):25-9. doi: 10.1016/j.jns.2004.03.006.
PubMed 15178209Bushnell C, Chireau M. Preeclampsia and Stroke: Risks during and after Pregnancy. Stroke Res Treat. 2011 Jan 20;2011:858134. doi: 10.4061/2011/858134.
PubMed 21331165Benschop L, Duvekot JJ, Versmissen J, van Broekhoven V, Steegers EAP, Roeters van Lennep JE. Blood Pressure Profile 1 Year After Severe Preeclampsia. Hypertension. 2018 Mar;71(3):491-498. doi: 10.1161/HYPERTENSIONAHA.117.10338.
PubMed 29437895Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.
PubMed 31727424Haug EB, Horn J, Markovitz AR, Fraser A, Klykken B, Dalen H, Vatten LJ, Romundstad PR, Rich-Edwards JW, Asvold BO. Association of Conventional Cardiovascular Risk Factors With Cardiovascular Disease After Hypertensive Disorders of Pregnancy: Analysis of the Nord-Trondelag Health Study. JAMA Cardiol. 2019 Jul 1;4(7):628-635. doi: 10.1001/jamacardio.2019.1746.
PubMed 31188397Wu P, Haththotuwa R, Kwok CS, Babu A, Kotronias RA, Rushton C, Zaman A, Fryer AA, Kadam U, Chew-Graham CA, Mamas MA. Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003497. doi: 10.1161/CIRCOUTCOMES.116.003497. Epub 2017 Feb 22.
PubMed 28228456Fasanya HO, Hsiao CJ, Armstrong-Sylvester KR, Beal SG. A Critical Review on the Use of Race in Understanding Racial Disparities in Preeclampsia. J Appl Lab Med. 2021 Jan 12;6(1):247-256. doi: 10.1093/jalm/jfaa149.
PubMed 33227139Ouyang P, Sharma G. The Potential for Pregnancy Heart Teams to Reduce Maternal Mortality in Women With Cardiovascular Disease. J Am Coll Cardiol. 2020 Nov 3;76(18):2114-2116. doi: 10.1016/j.jacc.2020.09.007. No abstract available.
PubMed 33121719
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education to Reduce Emergency Department Visits, Re-admissions and Adverse Cardiovascular Outcomes in Hypertensive Disorder of Pregnancy
- ClinicalTrials.gov ID
- NCT06920563
- Acronym / sponsor ID
- 2023.192
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 9 Apr 2025 (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.
The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are:
Is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? Does a structured program reduce the occurrence of postpartum hypertension, ED visits, hospital readmissions, and adverse outcomes?
Participants will:
View an educational video on HDP post-delivery Receive 1-2 times daily text messages for 6 weeks postpartum Have their blood pressure medications adjusted to lower targets post partum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Video, Other: Text Reminder, Other: Blood pressure thresholdThis group will watch an education video, receive text message updates, and have their blood pressure medications titrated to a lower BP goal. |
| Control | No intervention | –This group will receive usual post partum care from their obstetrician |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of at least 18 years.
- Postpartum status.
- Experience new-onset hypertension during pregnancy.
- Enrollment in Connected MOM.
- Ability to provide informed consent.
Key exclusion criteria (10 listed)
- History of preeclampsia or gestational hypertension during previous pregnancy
- History of chronic hypertension
- History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
- History of ischemic CVA
- History of Congestive heart failure
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 |
|---|---|---|
| VideoThose in the intervention arm will watch a short educational video. | Other | Intervention |
| Text ReminderThose in the intervention group will receive regular text message reminders to check their blood pressures | Other | Intervention |
| Blood pressure thresholdThose in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards | Other | Intervention |
Primary outcome
Engagement
Time frame: 6 weeks
Engagement will be defined by frequency of use: number of remote BP measurements ascertained during the 6 week postpartum period.
Acceptability
Time frame: 6 weeks
Post program survey questions using 5-item Likert response scale at 6 weeks postpartum
Duration of Participation
Time frame: 6 weeks
Duration of participation is defined by the last day of recorded remote BP measurement
5 secondary outcomes
Post partum Blood pressure
Time frame: 1 year
Number of ED visits
Time frame: 1 year
Severe Maternal Morbidity
Time frame: 1 year
Number of Inpatient re-admissions
Time frame: 1 year
Post partum visit follow up
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 38280432Mitro SD, Hedderson M, Xu F, Forquer H, Baker JM, Kuzniewicz MW, Greenberg M. Risk of postpartum readmission after hypertensive disorder of pregnancy and variation by discharge antihypertensive medication prescription. Am J Obstet Gynecol. 2024 Oct;231(4):456.e1-456.e13. doi: 10.1016/j.ajog.2024.01.015. Epub 2024 Jan 25.
- Background: PubMed 26551272SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
- Background: PubMed 29967037Cairns AE, Tucker KL, Leeson P, Mackillop LH, Santos M, Velardo C, Salvi D, Mort S, Mollison J, Tarassenko L, McManus RJ; SNAP-HT Investigators. Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Hypertension. 2018 Aug;72(2):425-432. doi: 10.1161/HYPERTENSIONAHA.118.10911. Epub 2018 Jul 2.
- Background: PubMed 34176288Kitt JA, Fox RL, Cairns AE, Mollison J, Burchert HH, Kenworthy Y, McCourt A, Suriano K, Lewandowski AJ, Mackillop L, Tucker KL, McManus RJ, Leeson P. Short-Term Postpartum Blood Pressure Self-Management and Long-Term Blood Pressure Control: A Randomized Controlled Trial. Hypertension. 2021 Aug;78(2):469-479. doi: 10.1161/HYPERTENSIONAHA.120.17101. Epub 2021 Jun 28.
- Background: PubMed 31503166Hauspurg A, Lemon LS, Quinn BA, Binstock A, Larkin J, Beigi RH, Watson AR, Simhan HN. A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level. Obstet Gynecol. 2019 Oct;134(4):685-691. doi: 10.1097/AOG.0000000000003479.
- Background: PubMed 38934890Mujic E, Parker SE, Nelson KP, O'Brien M, Chestnut IA, Abrams J, Yarrington CD. Implementation of a Cell-Enabled Remote Blood Pressure Monitoring Program During the Postpartum Period at a Safety-Net Hospital. J Am Heart Assoc. 2024 Jul 2;13(13):e034031. doi: 10.1161/JAHA.123.034031. Epub 2024 Jun 27.
- Background: PubMed 16894102Bateman BT, Schumacher HC, Bushnell CD, Pile-Spellman J, Simpson LL, Sacco RL, Berman MF. Intracerebral hemorrhage in pregnancy: frequency, risk factors, and outcome. Neurology. 2006 Aug 8;67(3):424-9. doi: 10.1212/01.wnl.0000228277.84760.a2.
- Background: PubMed 15178209Jeng JS, Tang SC, Yip PK. Stroke in women of reproductive age: comparison between stroke related and unrelated to pregnancy. J Neurol Sci. 2004 Jun 15;221(1-2):25-9. doi: 10.1016/j.jns.2004.03.006.
- Background: PubMed 21331165Bushnell C, Chireau M. Preeclampsia and Stroke: Risks during and after Pregnancy. Stroke Res Treat. 2011 Jan 20;2011:858134. doi: 10.4061/2011/858134.
- Background: PubMed 29437895Benschop L, Duvekot JJ, Versmissen J, van Broekhoven V, Steegers EAP, Roeters van Lennep JE. Blood Pressure Profile 1 Year After Severe Preeclampsia. Hypertension. 2018 Mar;71(3):491-498. doi: 10.1161/HYPERTENSIONAHA.117.10338.
- Background: PubMed 31727424Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.
- Background: PubMed 31188397Haug EB, Horn J, Markovitz AR, Fraser A, Klykken B, Dalen H, Vatten LJ, Romundstad PR, Rich-Edwards JW, Asvold BO. Association of Conventional Cardiovascular Risk Factors With Cardiovascular Disease After Hypertensive Disorders of Pregnancy: Analysis of the Nord-Trondelag Health Study. JAMA Cardiol. 2019 Jul 1;4(7):628-635. doi: 10.1001/jamacardio.2019.1746.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video, Text Reminder and Blood pressure threshold in people with Pre-Eclampsia; Complicating Pregnancy and Gestational Hypertension, run by Ochsner Health System 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salima Qamruddin, MD (+1 (504) 842-4135, salima.qamruddin@ochsner.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT06920563, which also lists 18 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 9 Apr 2025.