A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.
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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, Arulkumaran Sabaratnam, Bhutta Zulfiqar A, Gulmezoglu Ahmet M, Coomarasamy Arri
Аннотация
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.).