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162 mg of Aspirin for Prevention of Preeclampsia

Primary Purpose

Preeclampsia

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aspirin 162 mg

About this trial

This is an interventional prevention trial for Preeclampsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

UnityPoint Clinic Family MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention with 162 mg aspirin

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with preeclampsia

Dangerous pregnancy complication characterized by high blood pressure

Number of participants with eclampsia

new onset of seizures in pregnant woman with preeclampsia

Secondary Outcome Measures

Number of participants with placental abruption

Separation of placenta from the uterus prior to delivery

Number of participants with post partum hemorrhage

blood loss after delivery

Number of participants with aplastic anemia

deficiency of all blood cell lines

Number of participants with agranulocytosis

deficiency of granulocytes

Number of participants with anaphylaxis

serious allergic reaction

Full Information

NCT ID

NCT05221164

First Posted

August 23, 2021

Last Updated

January 22, 2022

Sponsor

Methodist Medical Center of Illinois

Collaborators

University of Illinois College of Medicine at Peoria, UICOM Peoria Family Medicine Residency

1. Study Identification

Unique Protocol Identification Number

NCT05221164

Brief Title

162 mg of Aspirin for Prevention of Preeclampsia

Official Title

162 mg of Aspirin for Prevention of Preeclampsia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2021 (Actual)

Primary Completion Date

June 9, 2022 (Anticipated)

Study Completion Date

June 9, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Methodist Medical Center of Illinois

Collaborators

University of Illinois College of Medicine at Peoria, UICOM Peoria Family Medicine Residency

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention with 162 mg aspirin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin 162 mg

Other Intervention Name(s)

Aspirin

Intervention Description

Daily aspirin 162 mg during pregnancy to prevent preeclampsia

Primary Outcome Measure Information:

Title

Number of participants with preeclampsia

Description

Dangerous pregnancy complication characterized by high blood pressure

Time Frame

Through study completion, estimated 18 months

Title

Number of participants with eclampsia

Description

new onset of seizures in pregnant woman with preeclampsia

Time Frame

Anytime during pregnancy and 3 months post partum

Secondary Outcome Measure Information:

Title

Number of participants with placental abruption

Description

Separation of placenta from the uterus prior to delivery

Time Frame

Through study completion, estimated 18 months

Title

Number of participants with post partum hemorrhage

Description

blood loss after delivery

Time Frame

Through study completion, estimated 18 months

Title

Number of participants with aplastic anemia

Description

deficiency of all blood cell lines

Time Frame

Through study completion, estimated 18 months

Title

Number of participants with agranulocytosis

Description

deficiency of granulocytes

Time Frame

Through study completion, estimated 18 months

Title

Number of participants with anaphylaxis

Description

serious allergic reaction

Time Frame

Through study completion, estimated 18 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

UnityPoint Clinic Family Medicine

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Goldsmith, MD

Phone

816-838-8335

paul.goldsmith@unitypoint.org

First Name & Middle Initial & Last Name & Degree

Andras Eder, MD

Phone

619-995-2529

andras.eder@unitypoint.org

First Name & Middle Initial & Last Name & Degree

Paul Goldsmith, MD

First Name & Middle Initial & Last Name & Degree

Andras Eder, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All collected IPD for statistical analysis and study report.

IPD Sharing Time Frame

After study completion for analysis and completion of final publication.

IPD Sharing Access Criteria

Statistician access.

Citations:

PubMed Identifier

29939940

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.

Results Reference

result

PubMed Identifier

28741785

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. Erratum In: Ultrasound Obstet Gynecol. 2017 Dec;50(6):807.

Results Reference

result

PubMed Identifier

29039130

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.

Results Reference

result

PubMed Identifier

31684684

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.

Results Reference

result

PubMed Identifier

32030002

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.

Results Reference

result

PubMed Identifier

724339

Citation

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

Results Reference

result

PubMed Identifier

3888490

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.

Results Reference

result

PubMed Identifier

27640943

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.

Results Reference

result

PubMed Identifier

32835720

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.

Results Reference

result

PubMed Identifier

28657417

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.

Results Reference

result

PubMed Identifier

29588190

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.

Results Reference

result

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162 mg of Aspirin for Prevention of Preeclampsia

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