Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation
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|ClinicalTrials.gov Identifier: NCT01856985|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : October 11, 2013
These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.
Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.
|Condition or disease||Intervention/treatment||Phase|
|Medical Abortion||Drug: Misoprostol Drug: Mifepristone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Misoprostol at clinic
Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home.
Participants will be asked to return to the hospital 14 days later for a follow-up visit.
- Percentage of women who have undergone a successful abortion [ Time Frame: 2 weeks ]
- Women's acceptability of the assigned method. [ Time Frame: 2 weeks ]
- Side effects [ Time Frame: 48 hours ]Side effects include nausea, vomiting, pain, diarrhea, fever. Asked women to rank as none, mild, moderate, severe. Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women
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): NCT01856985
|Hung Vuong Hospital|
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Principal Investigator:||Jennifer Blum, MPH||Gynuity Health Projects|
|Principal Investigator:||Nguyen Thu Nhu Ngoc, MD||Center for Research and Consultancy in Reproductive Health|
|Principal Investigator:||Dina F Abbas||Gynuity Health Projects|