| Methods |
RCT. Computer generated randomization scheme in blocks of four, six, and eight. Sequentially numbered, opaque, sealed envelopes. 12 mo follow‐up. |
| Participants |
1490 sexually active women, 14‐24 yrs, who did not desire pregnancy and were attending clinics in Nevada and North Carolina. Excluded if using or planning on using sterilization, IUD, hormonal contraception, or if pregnant or breastfeeding in past 6 wks. |
| Interventions |
Intervention group received two courses (two tabs of 0.75 mg levonorgestrel) to be taken together in one dose. More courses provided, attempt to ensure two packages on hand at all times. Control group received EC on request at a clinic. |
| Outcomes |
Pregnancy rates, STI rates (gonorrhea, Chlamydia, trichomoniasis), use of EC, interval between unprotected intercourse and EC use, frequency of unprotected intercourse, change in contraceptive methods, condom use. |
| Notes |
Small loss to follow‐up (6%). Pregnancy and STIs outcomes based primarily on medical chart review plus testing at follow‐up, some women self‐tested at home, sent vaginal samples for confirmation. Powered to detect a difference in pregnancy rates. More intervention participants had STIs at baseline; differences controlled for, adjustment did not substantially change results. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
|
