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. 2012 Mar 14;2012(3):CD005217. doi: 10.1002/14651858.CD005217.pub2
Methods ‐ Single centre, Denmark (Copenhagen)
‐ Study period not reported
‐ Follow‐up visit after 2 weeks
Participants ‐ 90 women randomised, 55 analysed
‐ Women presenting for surgical abortion in first trimester
‐ Exclusion criteria: allergy to treatment; antibiotic treatment at the time of abortion; active haematological or neurological disease; alcohol abuse; positive test for N. gonorrhoeae
‐ Preoperative infections:
1) History of PID: all women, 24/24 in arm 1, 31/31 in arm 2
2) Chlamydia: arm 1: 2/24, arm 2: 1/31
3) Gonorrhoea: not reported but all women tested and if positive excluded
4) Bacterial vaginosis: not reported
Interventions Antibiotic prophylaxis compared to placebo
‐ Intervention, arm 1: lymecycline 300 mg once daily, oral (pre‐ and postoperative, starting on the morning of the operation, total 14 days)
‐ Control, arm 2: placebo
Outcomes 1) Post‐abortal infection defined as:
a) Patient seen at follow‐up visit after 2 weeks, at least 3 of the following: temperature > 38 °C; continued pelvic pain; malaise with tender adnexal mass; pathologic discharge or bleeding
b) Patient admitted before scheduled follow‐up, at least 2 of the following: temperature > 38 °C; moderate tenderness of the uterus; tender adnexal mass; pathologic discharge or bleeding; OR
c) Patient not seen at the follow‐up visit, at least 4 of the following: temperature > 38 °C for > 24h; pelvic pain > 5 days; bleeding more than normal menstrual flow for > 5 days; foul discharge; infection diagnosed by physician
2) Readmission to hospital
Notes Not universal antibiotic prophylaxis according to protocol definition; study population included only women without gonorrhoea at baseline. All had a history of PID.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk
Incomplete outcome data (attrition bias) Low risk