Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.
The goal of this study is to provide answers to the following four questions:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 200mg mifepristone followed by 400mcg misoprostol |
|
| 2 | Active Comparator | 200mg mifepristone followed by 800mcg misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone, misoprostol | Drug | 200mg mifepristone followed by 400mcg misoprostol 36-48 hours later |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). | Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Side-effects, acceptability for women | side effects and acceptability recorded at exit interview |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Erica Chong, MPH | Gynuity Health Projects | Study Director |
| Tamuna Tsereteli, MD, MSc, PhD | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity House #2 | Tbilisi | Georgia | ||||
| Maternity House #4 |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| mifepristone, misoprostol |
| Drug |
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later |
|
| Tbilisi |
| Georgia |
| Zhordania Institute of Human Reproduction | Tbilisi | Georgia |
| Hocmon Hospital | Ho Chi Minh City | Vietnam |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |