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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mf+Ms | Experimental | The women in mifepristone combined misoprostol group (Mf+Ms) 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 |
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| Ms-alone | Experimental | The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone combined misoprostol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| complete abortion rate | study day 17 (14 days after misoprostol) |
| Measure | Description | Time Frame |
|---|---|---|
| side effects, timing of expulsion and duration of bleeding | timing of expulsion at day 17, others at 45day after abortion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YiYang Zhu, MD | Centra for Reproductive Medicine of Taizhou hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Hospital of zhejiang Province | Taizhou | Zhejiang | 317000 | China |
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| misoprostol alone protocol | Drug | patients were only administered 0.8 mg of misoprostol orally on day 3. |
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