Extrait

Background and study aims Infection following miscarriage surgery is a problem affecting over 33 million pregnancies each year. A majority of women will have their miscarriage managed with surgery to empty the womb. Infection can occur following this surgery and this is a particular problem in low income countries. In some low income countries the rates of infection following miscarriage surgery are as high as 30%. These infections can result in death, serious illness or long-term health problems. Currently international and national medical guidelines do not recommend antibiotics to be given routinely in miscarriage surgery, because there is no evidence that tells us that this works. If antibiotics are given just before the procedure of miscarriage surgery this may reduce the chance of infection occurring. The aim of this study is to test this in four low income countries. Who can participate? Women who have suffered a miscarriage and are scheduled to have their miscarriage managed surgically, through an operation to empty their uterus. What does the study involve? Participants are offered either a single dose of prophylactic antibiotics (doxycycline and metronidazole) or an identical looking dummy pill (placebo), to be taken by mouth before the surgery. Participants are followed for 2 weeks after surgery to see if there is any difference in the rate of women developing pelvic infection. If any women show signs of infection they are given full treatment as soon as it is detected. The study also assess whether using antibiotics before surgery is cost effective. What are the possible benefits and risks of participating? Those women taking part in the study may benefit by having their health followed very carefully after the surgery. The study team also facilitate these women receiving prompt treatment if there are any problems. Even if participants do not benefit personally they study may help improve care for women in the future. Risks of taking part include the small risk of side effects from doxycycline or metronidazole, but these medications have been selected because they have a low risk of serious side effects such as allergy. Where is the study run from? The study is being managed and sponsored by the University of Birmingham (UK). The study sites are: 1. Malawi: Queen Elizabeth Central Hospital, Zomba Central Hospital and Kamuzu Central Hospital 2. Uganda: Mbale Regional Referral Hospital and Soroti Regional Referral Hospital 3. Tanzania: St Francis Hospital, Mwananyamala Hospital and Bagamoyo District Hospital 4. Pakistan: Aga Khan University Main Hospital, Hyderabad Hospital, Garden Hospital, Kharader Hospital and Karimabad Hospital When is the study starting and how long is it expected to run for? September 2013 to May 2017 Who is funding the study? The Medical Research Council, the Wellcome Trust and the Department for International Development (UK) Who is the main contact? Dr David Lissauer [email protected]

Critère d'inclusion

• Infection, miscarriage, sepsis, antibiotic prophylaxis

Liens

• isrctn
• ictrp