A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery

David Lissauer, Amie Wilson, Catherine A. Hewitt, Lee Middleton, Jonathan R.B. Bishop, Jane Daniels, Abi Merriel, Andrew Weeks, Chisale Mhango, Ronald Mataya, Frank Taulo, Theresa Ngalawesa, Agatha Chirwa, Colleta Mphasa, Tayamika Tambala, Grace Chiudzu, Caroline Mwalwanda, Agnes Mboma, Rahat Qureshi, Iffat AhmedHumera 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

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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.).

Original languageEnglish
Pages (from-to)401-402
Number of pages2
JournalNew England Journal of Medicine
Volume74
Issue number7
Early online date14 Mar 2019
DOIs
Publication statusPublished - 1 Jul 2019

Bibliographical note

Copyright © 2019 Massachusetts Medical Society.

Keywords

  • Abortion, Spontaneous/surgery
  • Administration, Oral
  • Adolescent
  • Adult
  • Africa South of the Sahara
  • Antibiotic Prophylaxis
  • Developing Countries
  • Double-Blind Method
  • Doxycycline/adverse effects
  • Female
  • Humans
  • Metronidazole/adverse effects
  • Pakistan
  • Pelvic Infection/epidemiology
  • Postoperative Complications/epidemiology
  • Pregnancy
  • Preoperative Care
  • Treatment Outcome

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    Lissauer, D., Wilson, A., Hewitt, C. A., Middleton, L., Bishop, J. R. B., Daniels, J., Merriel, A., Weeks, A., Mhango, C., Mataya, R., Taulo, F., Ngalawesa, T., Chirwa, A., Mphasa, C., Tambala, T., Chiudzu, G., Mwalwanda, C., Mboma, A., Qureshi, R., ... Coomarasamy, A. (2019). A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery. New England Journal of Medicine, 74(7), 401-402. https://doi.org/10.1056/NEJMoa1808817