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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | This group will receive usual post partum care from their obstetrician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video | Other | Those in the intervention arm will watch a short educational video. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | Engagement will be defined by frequency of use: number of remote BP measurements ascertained during the 6 week postpartum period. | 6 weeks |
| Acceptability | Post program survey questions using 5-item Likert response scale at 6 weeks postpartum | 6 weeks |
| Duration of Participation | Duration of participation is defined by the last day of recorded remote BP measurement | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Number of ED visits | Number of ED visits recorded after discharge from her delivery encounter over the following year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salima Qamruddin, MD | Contact | +1 (504) 842-4135 | salima.qamruddin@ochsner.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Baptist | Recruiting | New Orleans | Louisiana | 70115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38280432 | Background | 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. | |
| 26551272 |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D011248 | Pregnancy Complications |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| Text Reminder |
| Other |
Those in the intervention group will receive regular text message reminders to check their blood pressures |
|
| Blood pressure threshold | Other | Those in the intervention group will have a lower blood pressure threshold to titrate their BP medications towards |
|
| 1 year |
| Severe Maternal Morbidity | Incidence of death, postpartum stroke, congestive heart failure, myocardial infarction, eclampsia | 1 year |
| Number of Inpatient re-admissions | Number of inpatient re-admissions over the following year after discharge from delivery encounter | 1 year |
| Post partum visit follow up | Proportion of 4-6 week postpartum follow up visit attendance with OB provider | 6 weeks |
| SPRINT 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. |
| 29967037 | Background | Cairns 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. |
| 34176288 | Background | Kitt 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. |
| 31503166 | Background | Hauspurg 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. |
| 38934890 | Background | Mujic 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. |
| 16894102 | Background | Bateman 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. |
| 15178209 | Background | Jeng 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. |
| 21331165 | Background | Bushnell C, Chireau M. Preeclampsia and Stroke: Risks during and after Pregnancy. Stroke Res Treat. 2011 Jan 20;2011:858134. doi: 10.4061/2011/858134. |
| 29437895 | Background | Benschop 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. |
| 31727424 | Background | Honigberg 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. |
| 31188397 | Background | Haug 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. |
| 28228456 | Background | Wu 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. |
| 33227139 | Background | Fasanya 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. |
| 33121719 | Background | Ouyang 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. |
| 33322915 | Background | Gad MM, Elgendy IY, Mahmoud AN, Saad AM, Isogai T, Sande Mathias I, Misbah Rameez R, Chahine J, Jneid H, Kapadia SR. Disparities in Cardiovascular Disease Outcomes Among Pregnant and Post-Partum Women. J Am Heart Assoc. 2021 Jan 5;10(1):e017832. doi: 10.1161/JAHA.120.017832. Epub 2020 Dec 16. |
| 30920918 | Background | Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276. |
| 31730305 | Background | Croke L. Gestational Hypertension and Preeclampsia: A Practice Bulletin from ACOG. Am Fam Physician. 2019 Nov 15;100(10):649-650. No abstract available. |
| D002318 | Cardiovascular Diseases |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |