162 mg of Aspirin for Prevention of Preeclampsia

Preeclampsia Clinical Trial

Official title:

162 mg of Aspirin for Prevention of Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221164
• Other study ID #: 1732470-3
• Status: Recruiting
• Phase: Phase 4
• Start date: July 6, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: January 2022
• Source: Methodist Medical Center of Illinois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
United States	UnityPoint Clinic Family Medicine	Peoria	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Methodist Medical Center of Illinois	UICOM Peoria Family Medicine Residency, University of Illinois College of Medicine at Peoria

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View 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). doi: 10.1002/14651858.CD004659.pub3. — View 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 Contr — View Citation

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

Needs CJ, Brooks PM. Clinical pharmacokinetics of the salicylates. Clin Pharmacokinet. 1985 Mar-Apr;10(2):164-77. Review. — View 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 — View Citation

Rolnik DL, Nicolaides KH, Poon LC. Prevention of preeclampsia with aspirin. Am J Obstet Gynecol. 2020 Aug 21. pii: S0002-9378(20)30873-5. doi: 10.1016/j.ajog.2020.08.045. [Epub ahead of print] Review. — View 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 ve — View 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 pr — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with preeclampsia	Dangerous pregnancy complication characterized by high blood pressure	Through study completion, estimated 18 months
Primary	Number of participants with eclampsia	new onset of seizures in pregnant woman with preeclampsia	Anytime during pregnancy and 3 months post partum
Secondary	Number of participants with placental abruption	Separation of placenta from the uterus prior to delivery	Through study completion, estimated 18 months
Secondary	Number of participants with post partum hemorrhage	blood loss after delivery	Through study completion, estimated 18 months
Secondary	Number of participants with aplastic anemia	deficiency of all blood cell lines	Through study completion, estimated 18 months
Secondary	Number of participants with agranulocytosis	deficiency of granulocytes	Through study completion, estimated 18 months
Secondary	Number of participants with anaphylaxis	serious allergic reaction	Through study completion, estimated 18 months