A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study

Matthew K. Hoffman, Shivaprasad S. Goudar, Bhalachandra S. Kodkany, Norman Goco, Marion Koso-Thomas, Menachem Miodovnik, Elizabeth M. McClure, Dennis D. Wallace, Jennifer J. Hemingway-Foday, Antoinette Tshefu, Adrien Lokangaka, Carl L. Bose, Elwyn Chomba, Musaku Mwenechanya, Waldemar A. Carlo, Ana Garces, Nancy F. Krebs, K. Michael Hambidge, Sarah Saleem, Robert L. GoldenbergArchana Patel, Patricia L. Hibberd, Fabian Esamai, Edward A. Liechty, Robert Silver, Richard J. Derman

Research output: Contribution to journalArticle

6 Citations (Scopus)

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. Trial registration: ClinicalTrials.gov identifier: NCT02409680Date: March 30, 2015

Original languageEnglish (US)
Article number135
JournalBMC Pregnancy and Childbirth
Volume17
Issue number1
DOIs
StatePublished - May 3 2017

Fingerprint

Premature Birth
Risk Reduction Behavior
Aspirin
Gestational Age
First Pregnancy Trimester
Pregnancy
Placebos
Eclampsia
Cost of Illness
Perinatal Mortality
Incidence
Infant Mortality
Pre-Eclampsia
Compliance
Clinical Trials
Parturition
Costs and Cost Analysis
Population

Keywords

  • Low dose Aspirin
  • Prematurity
  • Preterm birth

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Hoffman, M. K., Goudar, S. S., Kodkany, B. S., Goco, N., Koso-Thomas, M., Miodovnik, M., ... Derman, R. J. (2017). A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. BMC Pregnancy and Childbirth, 17(1), [135]. https://doi.org/10.1186/s12884-017-1312-x

A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. / Hoffman, Matthew K.; Goudar, Shivaprasad S.; Kodkany, Bhalachandra S.; Goco, Norman; Koso-Thomas, Marion; Miodovnik, Menachem; McClure, Elizabeth M.; Wallace, Dennis D.; Hemingway-Foday, Jennifer J.; Tshefu, Antoinette; Lokangaka, Adrien; Bose, Carl L.; Chomba, Elwyn; Mwenechanya, Musaku; Carlo, Waldemar A.; Garces, Ana; Krebs, Nancy F.; Hambidge, K. Michael; Saleem, Sarah; Goldenberg, Robert L.; Patel, Archana; Hibberd, Patricia L.; Esamai, Fabian; Liechty, Edward A.; Silver, Robert; Derman, Richard J.

In: BMC Pregnancy and Childbirth, Vol. 17, No. 1, 135, 03.05.2017.

Research output: Contribution to journalArticle

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 2017, 'A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study', BMC Pregnancy and Childbirth, vol. 17, no. 1, 135. https://doi.org/10.1186/s12884-017-1312-x
Hoffman, Matthew K. ; Goudar, Shivaprasad S. ; Kodkany, Bhalachandra S. ; Goco, Norman ; Koso-Thomas, Marion ; Miodovnik, Menachem ; McClure, Elizabeth M. ; Wallace, Dennis D. ; Hemingway-Foday, Jennifer J. ; Tshefu, Antoinette ; Lokangaka, Adrien ; Bose, Carl L. ; Chomba, Elwyn ; Mwenechanya, Musaku ; Carlo, Waldemar A. ; Garces, Ana ; Krebs, Nancy F. ; Hambidge, K. Michael ; Saleem, Sarah ; Goldenberg, Robert L. ; Patel, Archana ; Hibberd, Patricia L. ; Esamai, Fabian ; Liechty, Edward A. ; Silver, Robert ; Derman, Richard J. / A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. In: BMC Pregnancy and Childbirth. 2017 ; Vol. 17, No. 1.
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AU - Hoffman, Matthew K.

AU - Goudar, Shivaprasad S.

AU - Kodkany, Bhalachandra S.

AU - Goco, Norman

AU - Koso-Thomas, Marion

AU - Miodovnik, Menachem

AU - McClure, Elizabeth M.

AU - Wallace, Dennis D.

AU - Hemingway-Foday, Jennifer J.

AU - Tshefu, Antoinette

AU - Lokangaka, Adrien

AU - Bose, Carl L.

AU - Chomba, Elwyn

AU - Mwenechanya, Musaku

AU - Carlo, Waldemar A.

AU - Garces, Ana

AU - Krebs, Nancy F.

AU - Hambidge, K. Michael

AU - Saleem, Sarah

AU - Goldenberg, Robert L.

AU - Patel, Archana

AU - Hibberd, Patricia L.

AU - Esamai, Fabian

AU - Liechty, Edward A.

AU - Silver, Robert

AU - Derman, Richard J.

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