Management of Postpartum Preeclampsia

Postpartum Preeclampsia Clinical Trial

— MOPP  

Official title:

Management of Postpartum Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775744
• Other study ID #: Pro2022001222
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: March 26, 2024

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the effect of a lower treatment threshold for antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.

Description:

The aim of this study is to assess the effect of lower treatment threshold for initiating antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.

The investigators will study and compare two cohorts of patients. The first is a retrospective cohort, including patients delivered at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center. The second is a prospective cohort that will enroll patients immediately postpartum who are eligible for our treatment protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic hypertension, gestational hypertension, or preeclampsia.

• Delivery of a neonate after 20 weeks during their current hospitalization

• Able to consent

• 18 years old or above

• English or Spanish speaking

• Planning to follow up with a physician associated with Robert Wood Johnson University Hospital or Cooperman Barnabas Medical Center

• Ability to follow directions

Exclusion Criteria:

• Any medical condition that the providers feel is a contraindication to the MOPP algorithm.

• Planning to follow up with an outside institution.

• Unwillingness to take blood pressure at home.

Related Conditions & MeSH terms

• Postpartum Preeclampsia
• Pre-Eclampsia

Intervention

Other:
• Tight postpartum blood pressure control
The standard of care for patients with pregnancy induced hypertension is to start antihypertensive therapy if blood pressures are consistently over 150/100 mm Hg. There is no established standard of care for titrating blood pressure medication in the postpartum period for those with chronic hypertension and the approach to these patients varies by institution. The intervention in this study will be to start antihypertensive medications at a lower blood pressure cutoff, which is commonly used in the non-pregnant patient population to more tightly control blood pressure. Remote patient monitoring may be considered standard of care. The blood pressure targets chosen for this study are considered to be standard of care for non-pregnant people.

Locations

Country	Name	City	State
United States	Cooperman Barnabas Medical Center	Livingston	New Jersey
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (13)

Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8. — View Citation

Bruce KH, Anderson M, Stark JD. Factors associated with postpartum readmission for hypertensive disorders of pregnancy. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100397. doi: 10.1016/j.ajogmf.2021.100397. Epub 2021 May 12. — View Citation

Chen TY, Kao CW, Cheng SM, Chang YC. Effect of Home Medication Titration on Blood Pressure Control in Patients With Hypertension: A Meta-Analysis of Randomized Controlled Trials. Med Care. 2019 Mar;57(3):230-236. doi: 10.1097/MLR.0000000000001064. — View Citation

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. — View Citation

Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial disparities in postpartum blood pressure ascertainment. Am J Obstet Gynecol. 2019 Sep;221(3):283-285. doi: 10.1016/j.ajog.2019.05.011. Epub 2019 May 20. No abstract available. — View Citation

Hoppe KK, Williams M, Thomas N, Zella JB, Drewry A, Kim K, Havighurst T, Johnson HM. Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregnancy Hypertens. 2019 Jan;15:171-176. doi: 10.1016/j.preghy.2018.12.007. Epub 2018 Dec 31. — View Citation

Hypertension 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. — View Citation

Lash TL, Fox MP, MacLehose RF, Maldonado G, McCandless LC, Greenland S. Good practices for quantitative bias analysis. Int J Epidemiol. 2014 Dec;43(6):1969-85. doi: 10.1093/ije/dyu149. Epub 2014 Jul 30. — View Citation

McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Gooding T, Morrey I, Fisher C, Buckley D. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014 Aug 27;312(8):799-808. doi: 10.1001/jama.2014.10057. Erratum In: JAMA. 2014 Nov 26;312(20):2169. Gooding, Trevor [Added]; Morrey, Ian [Added]; Fisher, Crispin [Added]; Buckley, David [Added]. — View Citation

Patel S, Rodriguez AN, Macias DA, Morgan J, Kraus A, Spong CY. A Gap in Care? Postpartum Women Presenting to the Emergency Room and Getting Readmitted. Am J Perinatol. 2020 Dec;37(14):1385-1392. doi: 10.1055/s-0040-1712170. Epub 2020 May 30. — View Citation

Podymow T, August P. Postpartum course of gestational hypertension and preeclampsia. Hypertens Pregnancy. 2010;29(3):294-300. doi: 10.3109/10641950902777747. — View Citation

Tita AT, Szychowski JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz T, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Oparil S, Cutter GR, Andrews WW; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. Treatment for Mild Chronic Hypertension during Pregnancy. N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2. — View Citation

Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available. Erratum In: Hypertension. 2018 Jun;71(6):e140-e144. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum Emergency Department visits for hypertensive disorders	Any patient that returns to the Emergency Department for hypertensive disorders	Six weeks from date of delivery
Secondary	Postpartum readmissions for hypertensive disorders	Any patient that is readmitted to the hospital for hypertensive disorders.	6 weeks form date of delivery
Secondary	Number of acute postpartum complications of preeclampsia	Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury.	6 weeks from date of delivery
Secondary	Lab abnormalities because of preeclampsia	Rate of lab abnormalities including acute kidney injury (creatinine >1.1 mg/dL), transaminitis (liver function tests > 2x upper limit of normal), or thrombocytopenia (platelet count < 100,000 uL)	6 weeks from date of delivery
Secondary	Blood pressure at the postpartum visit	Measurement of blood pressure value at 6 week postpartum visit	6 weeks from date of delivery
Secondary	Breastfeeding rates at 6 weeks postpartum	Rates of exclusive breastfeeding at 6 week postpartum visit.	6 weeks from date of delivery
Secondary	Compliance with follow up at postpartum visits	If patient shows up to postpartum visit or not	6 weeks from date of delivery
Secondary	Composite maternal cardiovascular and other morbidity	Death, any new heart failure, stroke or encephalopathy, myocardial ischemia or angina, pulmonary edema, ICU admission/ intubation, encephalopathy, or renal failure.	One year from delivery
Secondary	Short-term cardiovascular disease	The effect of aggressive postpartum preeclampsia on incidents of cardiovascular diseases, which include coronary heart disease (acute myocardial infarction, ischemic heart disease, hypertensive heart disease, and congestive heart failure), and stroke (ischemic and hemorrhagic strokes).	One year from delivery
Secondary	Socioeconomic factors	The impact of race/ethnicity and insurance status on primary and secondary outcomes.	One year from delivery