| Methods |
Computer random number generator with blocked randomization, randomly varied block lengths. Allocation concealment by pre‐labeled pill bottles with drug or identical‐appearing placebo. |
| Participants |
1813 women requesting IUDs in family planning clinic at Kenyatta National Hospital, Nairobi, Kenya. Inclusion criteria: 20 to 44 years old with regular menses. Exclusion criteria: history of ectopic pregnancy, pregnancy within 42 days, leiomyomata uteri, active salpingitis, uterine malignancy, hypersensitivity to tetracyclines, antibiotic administration within 14 days, impaired immune response, residence outside Nairobi or low likelihood of follow up. All patients were screened for gonorrhea and chlamydial infection. |
| Interventions |
Doxycycline 200 mg by mouth one hour before IUD insertion or identical‐appearing placebo. |
| Outcomes |
Pelvic inflammatory disease diagnosed by Hager 1983 criteria; unscheduled visits back to the clinic. |
| Notes |
High follow rates; rigorous methods. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment by pre‐labeled pill bottles with drug or identical‐appearing placebo |
