Authors

Matthew K. Hoffman, Christiana Care, Newark, DE USA
Shivaprasad S. Goudar, KLE’s JN Medical College, Belgaum, India
Bhalachandra S. Kodkany, KLE’s JN Medical College, Belgaum, India
Norman Goco, RTI International, Research Triangle Park, NC USA.
Marion Koso-Thomas, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD USA.
Menachem Miodovnik, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD USA.
Elizabeth M. McClure, RTI International, Research Triangle Park, NC USA.
Dennis D. Wallace, RTI International, Research Triangle Park, NC USA.
Jennifer J. emingway-Foday, RTI International, Research Triangle Park, NC USA.
Antoinette Tshefu, Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
Adrien Lokangaka, Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
Carl L. Bose, University of North Carolina, Chapel Hill, NC USA.
Elwyn Chomba, University Teaching Hospital, Lusaka, Zambia
Musaku Mwenechanya, University Teaching Hospital, Lusaka, Zambia
Waldemar A. Carlo, University of Alabama at Birmingham, Birmingham, AL USA.
Ana Garces, Instituto de Nutrición de Centroamérica y Panamá (INCAP), Guatemala City, Guatemala
Nancy F. Krebs, University of Colorado School of Medicine, Denver, CO USA.
K. Michael Hambidge, University of Colorado School of Medicine, Denver, CO USA.
Sarah Saleem, Aga Khan UniversityFollow
Robert L. Goldenberg, Columbia University, New York, NY USA.
Archana Patel, Lata Medical Research Foundation, Nagpur, India
Patricia L. Hibberd, Boston University School of Public Health, Boston, MA USA.
Fabian Esamai, Moi University School of Medicine, Eldoret, Kenya
Edward A. Liechty, School of Medicine, Indiana University, Indianapolis, IN, USA.
Robert Silver, University of Utah, Salt Lake City, UT USA.
Richard J. Derman, Thomas Jefferson University, Philadelphia, PA USA.

Document Type

Article

Department

Community Health Sciences

Abstract

BACKGROUND:

Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB.

METHODS:

Hypothesis: LDA initiated in the first trimester reduces the risk of preterm birth. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control) Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.

INTERVENTION:

Daily administration of low dose (81 mg) aspirin, 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.

OUTCOMES:

Primary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA). Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality.

DISCUSSION:

This study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness.

Publication

BMC Pregnancy and Childbirth

Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.

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