Name (Synonyms) | Correlation |
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There is one clinical trial.
This study aims to assess efficacy and safety outcomes of a model of abortion care implemented in response to the COVID-19 pandemic. The study involves telehealth for counseling and information, to maintain social distancing, but requires participants to pick up their medications in the clinic in keeping with the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategy (REMS) requirements. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.
Description: The proportion of participants who have a successful abortion defined as complete abortion without continuing pregnancy, need for manual vacuum aspiration or an additional round of treatment to complete the abortion.
Measure: The proportion of participants with a successful abortion Time: Documented resolution of pregnancy, for most patients assessed at 7 daysDescription: The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.
Measure: The proportion of participants reporting satisfaction with telehealth for abortion Time: Documented satisfaction measured at approximately 4 weeks follow upDescription: The proportion of participants reporting they would use the telehealth option again if needed
Measure: The proportion of participants reporting they would use the telehealth option again if needed Time: Documented at approximately 4 weeks follow upDescription: The total percentage of participants who carried out the study tasks as directed.
Measure: The total percentage of participants who carried out the study tasks as directed. Time: Documented at the 7 day follow up surveyDescription: Major adverse events, either reported by the patient or documented through clinical records. Major adverse events will be defined as any abortion requiring blood transfusion, surgery, or hospitalization
Measure: The total percentage of participants who experienced a major adverse event Time: Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants