Preeclampsia Postpartum Antihypertensive Treatment (P-PAT)

Randomized Controlled Trial for Postpartum Antihypertensive Treatment of Women With Preeclampsia

The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Hypertension in Pregnancy
• Intervention / Treatment: Drug: Labetalol, Nifedipine

Detailed Description

This will be a randomized, controlled trial of 300 women with a diagnosis of preeclampsia at any point in their current pregnancy or immediately postpartum. Immediately postpartum is defined as preeclampsia diagnosed after delivery but prior to discharge from the hospital. The diagnosis of preeclampsia will be made using standardized definitions by the American College of Obstetrics and Gynecology. Preeclampsia is diagnosed with new-onset hypertension of blood pressure of greater than or equal to 140 systolic blood pressure or greater than or equal to 90 diastolic blood pressure recorded twice at least four hours apart AND proteinuria, defined as 300mg of protein in a 24hour urine collection or a protein/creatinine ratio of 0.3. If the above blood pressure criteria are met and there is not proteinuria, preeclampsia can still be diagnosed if there is thrombocytopenia with platelet count of less than 100,000, renal insufficiency with creatinine of greater than 1.1 or twice the patient's individual baseline, impaired liver function with AST or ALT twice normal or epigastric/right upper quadrant pain, pulmonary edema, new-onset headache unresponsive to medication, or visual disturbance. All of these findings should not be explained by an alternative diagnosis.

Women will be consented and randomized at the time of their diagnosis, within 96 hours of their delivery. The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol, nifedipine or hydralazine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. All subject's blood pressures will be monitored per standard postpartum protocols. As per standard practice, all patients with preeclampsia will be asked to return at 7-10 days for a blood pressure check and then again at 6 weeks for a complete postpartum assessment.

Consent of patients, review of blood pressures, data collection and storage, and statistical analysis will be performed at the Medical College of Wisconsin (MCW) through the Maternal Fetal medicine department. Women will be allowed to continue routine antenatal, intrapartum and postpartum care with their primary obstetrician. The research team will follow enrolled patients through the 6-week postpartum follow up.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mary Christine Livergood, MD; Phone Number: 414-805-6624; Email: mlivergood@mcw.edu
• Study Contact Backup: Name: Anna Palatnik, MD; Phone Number: 414-805-6624; Email: apalatnik@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin-Froedtert Hospital
      • Contact: Mary Christine Livergood; Phone Number: 3143463036 314-346-3036; Email: mlivergood@mcw.edu
      • Contact: Anna Palatnik; Phone Number: 414-805-6622; Email: apalatnik@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age >= 18 years old
• Immediately postpartum (delivered in previous 96 hours)
• Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum
• >30% of blood pressures in the postpartum period were elevated (systolic 140 or higher OR diastolic 90 or higher)

Exclusion Criteria:

• Chronic hypertension with superimposed preeclampsia
• Diagnosis of preeclampsia after discharge from delivery hospitalization
• Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team
• >50% of blood pressures in the postpartum period were normal (systolic less than 140 AND diastolic less than 90)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects.	Drug: Labetalol, Nifedipine; Antihypertensive treatment that is safe and well studied in peripartum women.; Other Names: Procardia; Trandate, Normodyne
No Intervention: No-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Readmission	Within 6 weeks from delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Healthcare Utilization	hospital readmissions, increased number of postpartum visits or phone calls, emergency room or urgent care visits, consultation with primary care (internal medicine, family medicine), cardiology, or maternal-fetal-medicine specialists	Within 6 weeks from delivery
percentage of severe range blood pressures at the 7-10 days postpartum visit		7-10 days postpartum
percentage of severe range blood pressures at the 6 week postpartum visit		Approximately 6 weeks postpartum
compare mean systolic and mean diastolic blood pressure values at 7-10 days postpartum and at 6weeks postpartum		6 weeks pospartum

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Publications and helpful links

General Publications

• ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy. Obstet Gynecol. 2019 Jan;133(1):e26-e50. doi: 10.1097/AOG.0000000000003020.
• Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.
• Sibai BM. Hypertensive disorders of pregnancy: the United States perspective. Curr Opin Obstet Gynecol. 2008 Apr;20(2):102-6. doi: 10.1097/GCO.0b013e3282f73380. No abstract available.
• Tan LK, de Swiet M. The management of postpartum hypertension. BJOG. 2002 Jul;109(7):733-6. doi: 10.1111/j.1471-0528.2002.01012.x. No abstract available.
• Ade-Conde JA, Alabi O, Higgins S, Visvalingam G. Maternal post natal hospital readmission-trends and association with mode of delivery. Ir Med J. 2011 Jan;104(1):17-20.
• Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
• Ferrazzani S, De Carolis S, Pomini F, Testa AC, Mastromarino C, Caruso A. The duration of hypertension in the puerperium of preeclamptic women: relationship with renal impairment and week of delivery. Am J Obstet Gynecol. 1994 Aug;171(2):506-12. doi: 10.1016/0002-9378(94)90290-9.
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Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nifedipine; Labetalol
• Other Study ID Numbers: PRO36760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No