To prevent an intrauterine pregnancy in women who have had unprotected intercourse and missed the emergency contraception window Pregnancy and Childbirth
Conditions
Interventions
1. Blood is drawn from women who meet the inclusion criteria to measure plasma ßhCG. If the value is >10 mIU/ml the women are included in the study. If lower than 10 mIU/ml, the women are requested to
Sponsors
Concept Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18 - 45 years 2. Regular menstrual cycles (duration of 25 – 35 days) 3. Intend to end the pregnancy if confirmed 4. Unprotected intercourse > 5 days but before expected menstruation 5. Positive plasma ßhCG (>10 mIU/ml) 6. Agree not to use any other contraception method during the study period 7. Literacy to read and understand the study procedures
Exclusion criteria
Exclusion criteria: 1. Irregular menstrual cycles 2. Breastfeeding 3. Unknown date of last menstrual period 4. Use of emergency contraception during the current menstrual cycle 5. Known allergy or any contraindication to levonorgestrel or mifepristone 6. Any systemic illness that requires the use of regular medications or any other serious medical disease 7. Any cases where the woman indicates pregnancy caused by rape, as the woman may need additional support and care. These women will be referred for appropriate services, including for termination of pregnancy where desired.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of the intervention measured by plasma ßhCG on Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of uterine bleeding after treatment measured using a self-recording questionnaire for day 1-2, and day 3-14 2. Length of post-treatment menstrual cycle measured using a self-recording questionnaire for day 1-2, and day 3-14 3. Satisfaction using the intervention measured using a self-recording questionnaire for day 3-14 4. Side-effects of drugs measured using a self-recording questionnaire for day 1-2, and day 3-14 | — |
Countries
Thailand
Outcome results
None listed