Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation
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|ClinicalTrials.gov Identifier: NCT00482209|
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : October 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Induced Abortion||Drug: Mifepristone, misoprostol Drug: mifepristone, misoprostol||Not Applicable|
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with buccal use tolerable for women?
- Is buccal administration of misoprostol acceptable to women?
- When given a choice, do women prefer to take misoprostol at home or in the clinic?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: 1
200mg mifepristone followed by 400mcg misoprostol
Drug: Mifepristone, misoprostol
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
Active Comparator: 2
200mg mifepristone followed by 800mcg misoprostol
Drug: mifepristone, misoprostol
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
- 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). [ Time Frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit ]
- Side-effects, acceptability for women [ Time Frame: side effects and acceptability recorded at exit interview ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482209
|Maternity House #2|
|Maternity House #4|
|Zhordania Institute of Human Reproduction|
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Study Director:||Erica Chong, MPH||Gynuity Health Projects|
|Study Director:||Tamuna Tsereteli, MD, MSc, PhD||Gynuity Health Projects|