162 mg of Aspirin for Prevention of Preeclampsia

Overview

This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Prevention
  • Masking: None (Open Label)
• Study Primary Completion Date: June 9, 2022

Detailed Description

After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia. At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Interventions

• Drug: Aspirin 162 mg
  • Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Arms, Groups and Cohorts

• Experimental: Intervention with 162 mg aspirin
  • Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic

Clinical Trial Outcome Measures

Primary Measures

• Number of participants with preeclampsia
  • Time Frame: Through study completion, estimated 18 months
  • Dangerous pregnancy complication characterized by high blood pressure
• Number of participants with eclampsia
  • Time Frame: Anytime during pregnancy and 3 months post partum
  • new onset of seizures in pregnant woman with preeclampsia

Secondary Measures

• Number of participants with placental abruption
  • Time Frame: Through study completion, estimated 18 months
  • Separation of placenta from the uterus prior to delivery
• Number of participants with post partum hemorrhage
  • Time Frame: Through study completion, estimated 18 months
  • blood loss after delivery
• Number of participants with aplastic anemia
  • Time Frame: Through study completion, estimated 18 months
  • deficiency of all blood cell lines
• Number of participants with agranulocytosis
  • Time Frame: Through study completion, estimated 18 months
  • deficiency of granulocytes
• Number of participants with anaphylaxis
  • Time Frame: Through study completion, estimated 18 months
  • serious allergic reaction

Participating in This Clinical Trial

Inclusion Criteria

• Any pregnant patient at Peoria FMC – Hx of pre-eclampsia – Multifetal gestation – Chronic hypertension – Type 1 or 2 diabetes – Autoimmune disease – Renal disease – Nulliparity – Obesity – Family Hx of pre-eclampsia – Sociodemographic characteristics – Age >= 35 years of age – Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes Exclusion Criteria:

• At high risk of side effects from ASA therapy – Hx of hemorrhagic stroke – Hx of GI bleed, G6PD – Liver disease – NSAID or Salicylate allergy) – Patients confirmed to be not compliant with therapy

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Methodist Medical Center of Illinois
• Collaborator
  • University of Illinois College of Medicine at Peoria
• Provider of Information About this Clinical Study
  • Principal Investigator: Paul M Goldsmith, DO, Resident Physician – Methodist Medical Center of Illinois

Citations Reporting on Results

ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.

Rolnik DL, Wright D, Poon LCY, Syngelaki A, O'Gorman N, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Nicolaides KH. ASPRE trial: performance of screening for preterm pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Oct;50(4):492-495. doi: 10.1002/uog.18816. Epub 2017 Aug 24. Erratum In: Ultrasound Obstet Gynecol. 2017 Dec;50(6):807.

Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for Prevention of Preeclampsia. Drugs. 2017 Nov;77(17):1819-1831. doi: 10.1007/s40265-017-0823-0.

Duley L, Meher S, Hunter KE, Seidler AL, Askie LM. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD004659. doi: 10.1002/14651858.CD004659.pub3.

Kumar N, Das V, Agarwal A, Pandey A, Agrawal S, Singh A. Pilot Interventional Study Comparing Fetomaternal Outcomes of 150 mg Versus 75 mg Aspirin Starting Between 11 and 14 Weeks of Pregnancy in Patients with High Risk of Preeclampsia: A Randomized Control Trial. J Obstet Gynaecol India. 2020 Feb;70(1):23-29. doi: 10.1007/s13224-019-01277-5. Epub 2019 Sep 20.

Levy G. Clinical pharmacokinetics of aspirin. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):867-72.

Needs CJ, Brooks PM. Clinical pharmacokinetics of the salicylates. Clin Pharmacokinet. 1985 Mar-Apr;10(2):164-77. doi: 10.2165/00003088-198510020-00004.

Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15.

Rolnik DL, Nicolaides KH, Poon LC. Prevention of preeclampsia with aspirin. Am J Obstet Gynecol. 2022 Feb;226(2S):S1108-S1119. doi: 10.1016/j.ajog.2020.08.045. Epub 2020 Aug 21.

Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

Seidler AL, Askie L, Ray JG. Optimal aspirin dosing for preeclampsia prevention. Am J Obstet Gynecol. 2018 Jul;219(1):117-118. doi: 10.1016/j.ajog.2018.03.018. Epub 2018 Mar 26. No abstract available.