Clinical trial NCT05221164: 162 mg of Aspirin for Prevention of Preeclampsia
Official title: 162 mg of Aspirin for Prevention of Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preeclampsia
Lead sponsor: Methodist Medical Center of Illinois
Sponsor class: OTHER
Collaborators: name: University of Illinois College of Medicine at Peoria
name: UICOM Peoria Family Medicine Residency
First posted: 2022-02-02
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with preeclampsia
timeFrame: Through study completion, estimated 18 months
measure: Number of participants with eclampsia
timeFrame: Anytime during pregnancy and 3 months post partum
Secondary outcomes:
measure: Number of participants with placental abruption
timeFrame: Through study completion, estimated 18 months
measure: Number of participants with post partum hemorrhage
timeFrame: Through study completion, estimated 18 months
measure: Number of participants with aplastic anemia
timeFrame: Through study completion, estimated 18 months
measure: Number of participants with agranulocytosis
timeFrame: Through study completion, estimated 18 months
measure: Number of participants with anaphylaxis
timeFrame: Through study completion, estimated 18 months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: UnityPoint Clinic Family Medicine
state: Illinois
Study officials:
References:
citation: ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Levy G. Clinical pharmacokinetics of aspirin. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):867-72.
citation: Needs CJ, Brooks PM. Clinical pharmacokinetics of the salicylates. Clin Pharmacokinet. 1985 Mar-Apr;10(2):164-77. doi: 10.2165/00003088-198510020-00004.
citation: 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.
citation: 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.
citation: 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.
citation: 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.