Methods | ‐ Single centre, Denmark (Copenhagen) ‐ Study period not reported ‐ Follow‐up visit after 2 weeks |
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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 |
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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 |
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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 |
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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 |