Abortion, Induced, Emergency Contraception
Conditions
Keywords
Medical abortion, emergency contraception, mifepristone
Brief summary
The purpose of this study is to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.
Detailed description
Women usually request an abortion when they have experienced an emergency contraception (EC) failure; this population represents 13% of all early pregnancy terminations in China. Many women would prefer to choose a medical abortion in order to avoid anesthesia, over a surgical operation. However, medical termination of a pregnancy after mifepristone EC failure has not been studied although it has already been extensively practiced by empirical means in China. There is no clarification in literature as to whether mifepristone is still effective in medical abortion with its previous failure experience in EC. This randomized study was aimed to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.
Interventions
DRUGmifepristone combined misoprostol
women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally
DRUGmisoprostol alone protocol
patients were only administered 0.8 mg of misoprostol orally on day 3.
Sponsors
Taizhou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Participants included in the study were women aged 16 years or older * with good general health, * experiencing a mifepristone emergency contraception failure, * presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and * seeking a medical abortion for unwanted pregnancy. * Women who had a threatened abortion or a failure pregnancy were also included. * Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete abortion rate | study day 17 (14 days after misoprostol) |
Secondary
| Measure | Time frame |
|---|---|
| side effects, timing of expulsion and duration of bleeding | timing of expulsion at day 17, others at 45day after abortion |
Countries
China
Outcome results
None listed