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The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone+misoprostol | Experimental | 200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| misoprostol | Experimental | 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone+misoprostol | Drug | single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fetal expulsion: defined as fetal expulsion with study drug alone. | 24 hours | |
| Induction-to-abortion interval | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Ob-Gyn Hospital | Hanoi | Vietnam | ||||
| Hung Vuong Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21860289 | Derived | Ngoc NTN, Shochet T, Raghavan S, Blum J, Nga NTB, Minh NTH, Phan VQ, Winikoff B. Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):601-608. doi: 10.1097/AOG.0b013e318227214e. |
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| misoprostol | Drug | placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| placebo | Drug | placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| Total dose of misoprostol. | Assessed at time of complete abortion with study drug alone or when total maximum dose given. |
| Pain experienced by the woman as self-reported. | Assessed during exit interview. |
| Ho Chi Minh City |
| Vietnam |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| 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 |
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