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A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery

Lissauer, David; Wilson, Amie; Hewitt, Catherine A.; Middleton, Lee; Bishop, Jonathan R.B.; Daniels, Jane; Merriel, Abi; Weeks, Andrew; Mhango, Chi Sale; Mataya, Ronald; Taulo, Frank; Ngalawesa, Theresa; Chirwa, Agatha; Mphasa, Colleta; Tambala, Tayamika; Chiudzu, Grace; Mwalwanda, Caroline; Mboma, Agnes; Qureshi, Rahat; Ahmed, Iffat; Ismail, Humera; Oladapo, Olufemi T.; Mbaruku, Godfrey; Chibwana, Jerome; Watts, Grace; Simon, Beatus; Ditai, James; Tom, Charles Otim; Acam, Jane Frances; Ekunait, John; Unzia, Hellen; Iyaku, Margaret; Makiika, Joshua J.; Zamora, Javier; Roberts, Tracy; Goranitis, Ilias; Bar-Zeev, Sarah; Desmond, Nicola; Arulkumaran, Sabaratnam; Bhutta, Zulfiqar A.; Gulmezoglu, Ahmet M.; Coomarasamy, Arri

Authors

David Lissauer

Amie Wilson

Catherine A. Hewitt

Lee Middleton

Jonathan R.B. Bishop

Abi Merriel

Andrew Weeks

Chi Sale Mhango

Ronald Mataya

Frank Taulo

Theresa Ngalawesa

Agatha Chirwa

Colleta Mphasa

Tayamika Tambala

Grace Chiudzu

Caroline Mwalwanda

Agnes Mboma

Rahat Qureshi

Iffat Ahmed

Humera Ismail

Olufemi T. Oladapo

Godfrey Mbaruku

Jerome Chibwana

Grace Watts

Beatus Simon

James Ditai

Charles Otim Tom

Jane Frances Acam

John Ekunait

Hellen Unzia

Margaret Iyaku

Joshua J. Makiika

Javier Zamora

Tracy Roberts

Ilias Goranitis

Sarah Bar-Zeev

Nicola Desmond

Sabaratnam Arulkumaran

Zulfiqar A. Bhutta

Ahmet M. Gulmezoglu

Arri Coomarasamy



Abstract

© 2019 Massachusetts Medical Society. BACKGROUND Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries. METHODS We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics. RESULTS We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P=0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events. CONCLUSIONS Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo.

Journal Article Type Article
Publication Date Mar 14, 2019
Journal New England Journal of Medicine
Print ISSN 0028-4793
Electronic ISSN 1533-4406
Publisher Massachusetts Medical Society
Peer Reviewed Peer Reviewed
Volume 380
Issue 11
Pages 1012-1021
APA6 Citation Lissauer, D., Wilson, A., Hewitt, C. A., Middleton, L., Bishop, J. R., Daniels, J., …Coomarasamy, A. (2019). A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery. New England Journal of Medicine, 380(11), 1012-1021. https://doi.org/10.1056/NEJMoa1808817
DOI https://doi.org/10.1056/NEJMoa1808817
Keywords General medicine
Publisher URL https://www.nejm.org/doi/10.1056/NEJMoa1808817
Additional Information From New England Journal of Medicine (03/14/19) Vol. 380, No. 11, P. 1012 Lissauer, David; Wilson, Amie; Hewitt, Catherine A.; et al.. Copyright © 2019 Massachusetts Medical Society. Reprinted with permission.

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