TY - JOUR
T1 - A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.
AU - Lissauer, David
AU - Wilson, Amie
AU - Hewitt, Catherine A.
AU - Middleton, Lee
AU - Bishop, Jonathan R.B.
AU - Daniels, Jane
AU - Merriel, Abi
AU - Weeks, Andrew
AU - Mhango, Chi Sale
AU - Mataya, Ronald
AU - Taulo, Frank
AU - Ngalawesa, Theresa
AU - Chirwa, Agatha
AU - Mphasa, Colleta
AU - Tambala, Tayamika
AU - Chiudzu, Grace
AU - Mwalwanda, Caroline
AU - Mboma, Agnes
AU - Qureshi, Rahat
AU - Ahmed, Iffat
AU - Ismail, Humera
AU - Oladapo, Olufemi T.
AU - Mbaruku, Godfrey
AU - Chibwana, Jerome
AU - Watts, Grace
AU - Simon, Beatus
AU - Ditai, James
AU - Tom, Charles Otim
AU - Acam, Jane Frances
AU - Ekunait, John
AU - Unzia, Hellen
AU - Iyaku, Margaret
AU - Makiika, Joshua J.
AU - Zamora, Javier
AU - Roberts, Tracy
AU - Goranitis, Ilias
AU - Bar-Zeev, Sarah
AU - Desmond, Nicola
AU - Arulkumaran, Sabaratnam
AU - Bhutta, Zulfiqar A.
AU - Gulmezoglu, Ahmet M.
AU - Coomarasamy, Arri
PY - 2019/3/14
Y1 - 2019/3/14
N2 - BACKGROUNDSurgical 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.METHODSWe 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.RESULTSWe 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.CONCLUSIONSAntibiotic 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.).
AB - BACKGROUNDSurgical 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.METHODSWe 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.RESULTSWe 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.CONCLUSIONSAntibiotic 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.).
U2 - 10.1056/nejmoa1808817
DO - 10.1056/nejmoa1808817
M3 - Article
SN - 0028-4793
VL - 380
SP - 1012
EP - 1021
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 11
ER -