Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)

NCT02409680 | Completed Results DMC

• 1 other identifier: CP ASPIRIN
• Study Type: interventional
• Target: 11,976
• Locations: 7 countries
• Sites: 14

Brief Summary

Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).

Conditions

Premature Birth

Keywords

Preterm birth; Low dose aspirin

Outcome Measures

Primary Outcomes (1)

• Incidence of Preterm Birth

  The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.

  At delivery

Secondary Outcomes (3)

• Incidence of Hypertensive Disorders of Pregnancy

  Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)

• Incidence of Small for Gestational Age (SGA)

  At delivery or at Day 42 after delivery

• Incidence of Perinatal Mortality

  At delivery or at Day 42 after delivery

Other Outcomes (14)

• Maternal Outcome 1 - Incidence of Vaginal Bleeding

  At delivery or at Day 42 after delivery

• Maternal Outcome 2 - Incidence of Antepartum Hemorrhage

  At delivery or at Day 42 after delivery

• Maternal Outcome 3 - Incidence of Postpartum Hemorrhage

  At delivery or at Day 42 after delivery

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Women will be randomized equally to receive daily low dose aspirin (LDA) \[also known as acetylsalicylic acid (ASA)\] of 81 mg beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.

Drug: Low dose aspirin

Placebo Arm

PLACEBO COMPARATOR

Women will be randomized equally to receive an identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.

Drug: Placebo

Interventions

Low dose aspirin DRUG

Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA\], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.

Also known as: Acetylsalicylic acid (ASA)

Intervention Arm

Placebo DRUG

Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous women between 18 - 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country's ethical guidelines.
• No more than two previous first trimester pregnancy losses
• No medical contraindications to aspirin;
• Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.

You may not qualify if:

• Women prescribed daily aspirin for more than 7 days;
• Multiple gestations;
• Hemoglobin \< 7.0 gm/dl at screening;
• Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, or any other known significant disease)
• Blood pressure ≥ 140/90 (Systolic blood pressure ≥ 140 and diastolic ≥ 90 at screening)

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Thomas Jefferson University: collaborator
• Jawaharlal Nehru Medical College: collaborator

Study Sites (14)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

Institute of Nutrition of Central America and Panama (INCAP)

Guatemala City, 01015, Guatemala

Location

KLE University's Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Location

Lata Medical Research Foundation

Nagpur, India

Location

Moi University School of Medicine

Eldoret, 30100, Kenya

Location

The Aga Khan University

Karachi, 74800, Pakistan

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (66)

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  PMID: 36890485 DERIVED

• Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, Lokangaka A, Tshefu A, Bose CL, Mwapule A, Mwenechanya M, Chomba E, Carlo WA, Chicuy J, Figueroa L, Garces A, Krebs NF, Jessani S, Zehra F, Saleem S, Goldenberg RL, Kurhe K, Das P, Patel A, Hibberd PL, Achieng E, Nyongesa P, Esamai F, Liechty EA, Goco N, Hemingway-Foday J, Moore J, Nolen TL, McClure EM, Koso-Thomas M, Miodovnik M, Silver R, Derman RJ; ASPIRIN Study Group. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jan 25;395(10220):285-293. doi: 10.1016/S0140-6736(19)32973-3.

  PMID: 31982074 DERIVED

• Hoffman MK, Goudar SS, Kodkany BS, Goco N, Koso-Thomas M, Miodovnik M, McClure EM, Wallace DD, Hemingway-Foday JJ, Tshefu A, Lokangaka A, Bose CL, Chomba E, Mwenechanya M, Carlo WA, Garces A, Krebs NF, Hambidge KM, Saleem S, Goldenberg RL, Patel A, Hibberd PL, Esamai F, Liechty EA, Silver R, Derman RJ. A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. BMC Pregnancy Childbirth. 2017 May 3;17(1):135. doi: 10.1186/s12884-017-1312-x.

  PMID: 28468653 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; 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

Results Point of Contact

• Title: Elizabeth McClure
• Organization: RTI International

mcclure@rti.org

919-316-3773

Study Officials

• Marion Koso-Thomas, MD

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 7, 2015
• Study Start: March 23, 2016
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: November 21, 2024
• Results First Posted: September 8, 2021

Record last verified: 2024-11

Locations

KE (1); US (7); PA (1); ZA (1); IN (2); DE (1); GU (1)