162 mg of Aspirin for Prevention of Preeclampsia

NCT05221164 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 1732470-3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (2)

• Number of participants with preeclampsia

  Dangerous pregnancy complication characterized by high blood pressure

  Through study completion, estimated 18 months

• Number of participants with eclampsia

  new onset of seizures in pregnant woman with preeclampsia

  Anytime during pregnancy and 3 months post partum

Secondary Outcomes (5)

• Number of participants with placental abruption

  Through study completion, estimated 18 months

• Number of participants with post partum hemorrhage

  Through study completion, estimated 18 months

• Number of participants with aplastic anemia

  Through study completion, estimated 18 months

• Number of participants with agranulocytosis

  Through study completion, estimated 18 months

• Number of participants with anaphylaxis

  Through study completion, estimated 18 months

Study Arms (1)

Intervention with 162 mg aspirin

EXPERIMENTAL

Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic

Drug: Aspirin 162 mg

Interventions

Aspirin 162 mg DRUG

Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Also known as: Aspirin

Intervention with 162 mg aspirin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Medical Center of Illinois: lead
• University of Illinois College of Medicine at Peoria: collaborator
• UICOM Peoria Family Medicine Residency: collaborator

Study Sites (1)

UnityPoint Clinic Family Medicine

Peoria, Illinois, 61602, United States

RECRUITING

Related Publications (11)

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

  PMID: 29939940 RESULT

• 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.

  PMID: 28741785 RESULT

• 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.

  PMID: 29039130 RESULT

• 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.

  PMID: 31684684 RESULT

• 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.

  PMID: 32030002 RESULT

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

  PMID: 724339 RESULT

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

  PMID: 3888490 RESULT

• 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.

  PMID: 27640943 RESULT

• 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.

  PMID: 32835720 RESULT

• 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.

  PMID: 28657417 RESULT

• 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.

  PMID: 29588190 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: February 2, 2022
• Study Start: July 6, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: After study completion for analysis and completion of final publication.
• Access Criteria: Statistician access.

Locations

US (1)