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

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.

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

• Journal Article Type: Article
• Acceptance Date: Dec 7, 2018
• Online Publication Date: Mar 14, 2019
• Publication Date: Mar 14, 2019
• Deposit Date: Apr 5, 2019
• Publicly Available Date: Sep 15, 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
• DOI: https://doi.org/10.1056/NEJMoa1808817
• Keywords: General medicine
• Public URL: https://nottingham-repository.worktribe.com/output/1751457
• 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.
• Contract Date: Apr 5, 2019