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Lissauer, David, Wilson, Amie, Hewitt, Catherine A, Middleton, Lee, Bishop, Jonathan R B, Daniels, Jane, Merriel, Abi, Weeks, Andrew, Mhango, Chisale, 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, Otim Tom, Charles, Acam, JaneFrances, Ekunait, John, Unzia, Hellen, Iyaku, Margaret, Makiika, Joshua J, Zamora, Javier, Roberts, Tracy, Goranitis, Ilias, Bar-Zeev, Sarah, Desmond, Nicola 
ORCID: https://orcid.org/0000-0002-2874-8569, Arulkumaran, Sabaratnam, Bhutta, Zulfiqar A, Gulmezoglu, Ahmet M and Coomarasamy, Arri
(2019)
'A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.'. New England Journal of Medicine, Vol 380, Issue 11, pp. 1012-1021.
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Abstract
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. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).
| Item Type: | Article |
|---|---|
| Subjects: | QV Pharmacology > Anti-Bacterial Agents. Tissue Extracts > QV 350 Anti-bacterial agents (General or not elsewhere classified) WQ Obstetrics > Pregnancy Complications > WQ 225 Spontaneous abortion. Fetal death WQ Obstetrics > Labor > WQ 330 Complications of labor WQ Obstetrics > Obstetric Surgical Procedures > WQ 400 General works |
| Digital Object Identifer (DOI): | https://doi.org/10.1056/NEJMoa1808817 |
| Depositing User: | Stacy Murtagh |
| Date Deposited: | 18 Mar 2019 11:30 |
| Last Modified: | 14 Sep 2019 01:02 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/10400 |
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