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Prophylactic antibiotics to reduce pelvic infection in women having miscarriage surgery – The AIMS (Antibiotics in Miscarriage Surgery) trial: study protocol for a randomized controlled trial

Overview of attention for article published in Trials, April 2018
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Title
Prophylactic antibiotics to reduce pelvic infection in women having miscarriage surgery – The AIMS (Antibiotics in Miscarriage Surgery) trial: study protocol for a randomized controlled trial
Published in
Trials, April 2018
DOI 10.1186/s13063-018-2598-3
Pubmed ID
Authors

David Lissauer, Amie Wilson, Jane Daniels, Lee Middleton, Jon Bishop, Catherine Hewitt, 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 Ahmed, Humera Ismail, Metin Gulmezoglu, Olufemi T. Oladapo, Godfrey Mbaruku, Jerome Chibwana, Grace Watts, Beatus Simon, James Ditai, Charles Otim Tom, Jane-Frances Acam, John Ekunait, Helen Uniza, Margaret Iyaku, Margaret Anyango, Javier Zamora, Tracy Roberts, Ilias Goranitis, Nicola Desmond, Arri Coomarasamy

Abstract

The estimated annual global burden of miscarriage is 33 million out of 210 million pregnancies. Many women undergoing miscarriage have surgery to remove pregnancy tissues, resulting in miscarriage surgery being one of the most common operations performed in hospitals in low-income countries. Infection is a serious consequence and can result in serious illness and death. In low-income settings, the infection rate following miscarriage surgery has been reported to be high. Good quality evidence on the use of prophylactic antibiotics for surgical miscarriage management is not available. Given that miscarriage surgery is common, and infective complications are frequent and serious, prophylactic antibiotics may offer a simple and affordable intervention to improve outcomes. Eligible patients will be approached once the diagnosis of miscarriage has been made according to local practice. Once informed consent has been given, participants will be randomly allocated using a secure internet facility (1:1 ratio) to a single dose of oral doxycycline (400 mg) and metronidazole (400 mg) or placebo. Allocation will be concealed to both the patient and the healthcare providers. A total of 3400 women will be randomised, 1700 in each arm. The medication will be given approximately 2 hours before surgery, which will be provided according to local practice. The primary outcome is pelvic infection 2 weeks after surgery. Women will be invited to the hospital for a clinical assessment at 2 weeks. Secondary outcomes include overall antibiotic use, individual components of the primary outcome, death, hospital admission, unplanned consultations, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms, and days before return to usual activities. An economic evaluation will be performed to determine if prophylactic antibiotics are cost-effective. This trial will assess whether a single dose of doxycycline (400 mg) and metronidazole (400 mg) taken orally 2 hours before miscarriage surgery can reduce the incidence of pelvic infection in women up to 2 weeks after miscarriage surgery. Registered with the ISRCTN (international standard randomised controlled trial number) registry: ISRCTN 97143849 . (Registered on April 17, 2013).

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 143 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 143 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 21 15%
Student > Postgraduate 12 8%
Student > Bachelor 12 8%
Researcher 11 8%
Student > Ph. D. Student 8 6%
Other 17 12%
Unknown 62 43%
Readers by discipline Count As %
Medicine and Dentistry 38 27%
Nursing and Health Professions 13 9%
Social Sciences 9 6%
Business, Management and Accounting 2 1%
Computer Science 2 1%
Other 11 8%
Unknown 68 48%