Preeclampsia Postpartum Antihypertensive Treatment

NCT04298034 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PRO36760
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission

  Within 6 weeks from delivery

Secondary Outcomes (4)

• Rate of Healthcare Utilization

  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

Study Arms (2)

Treatment

EXPERIMENTAL

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

No-treatment

NO INTERVENTION

Interventions

Labetalol, Nifedipine DRUG

Antihypertensive treatment that is safe and well studied in peripartum women.

Also known as: Procardia, Trandate, Normodyne

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin-Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (11)

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  PMID: 18388806 BACKGROUND

• 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.

  PMID: 29045342 BACKGROUND

• 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.

  PMID: 12135206 BACKGROUND

• 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.

  PMID: 21387880 BACKGROUND

• 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.

  PMID: 27829570 BACKGROUND

• 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.

  PMID: 8059832 BACKGROUND

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MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Labetalol; Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician will be masked to which group the patient was randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: July 17, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)