IMPLEMENTATION PERIOD: 01 February 2015 – 01 March 2016
DONOR: Gynuity Healths Projects
PROJECT GOAL: The primary aim of this pilot study is to obtain data on the safety and acceptability of outpatient medical abortion without a pretreatment pelvic ultrasound or exam.
The primary study objectives will be evaluated as follows:
- Incidence of serious adverse events. Serious adverse events will be ascertained during follow-up. The proportion of women in the No PE/US Population who have such events will be estimated, along with exact 95% confidence interval.
- Incidence of other significant abortion complications.These events will include any abortion-related medical problem that results in treatment at an emergency roomer urgent care center without subsequent hospitalization or any abortion complication or other event that the site investigator reports as significant. The proportion of women in the No PE/US Population who have such complications will be estimated, along with exact 95% confidence interval.
- Use of a surgical uterine evacuation or other surgical procedureor other surgery to complete the abortion. The proportion of women in the No PE/US Population who have a surgical uterine evacuation procedure or other surgerysurgical procedure to complete the abortion will be estimated, along with exact 95% confidence interval.
- Satisfaction with the procedure. This analysis will summarize data obtained about satisfaction with the abortion procedure and with forgoing a pretreatment ultrasound and pelvic examination. It will use the Enrolled Population.
To date, only one study has evaluated medical abortion without either an initial ultrasound or a pelvic exam. This study included 22 women in Canada who had medical abortion provided remotely at 35-42 days gestation. All study subjects were screened and counseled over internet video from their homes, and they submitted a serum specimen to a local laboratory for quantitative HCG level determination. The protocol specified that ultrasound was not needed if the level was <5,000 mIU/ml. Of the 15 women received the abortifacient drugs without ultrasound, none had any medical complications, and the one patient who was felt to need surgical completion was identified within a week.
Our pilot study aims to collect additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in women who meet three criteria: (a) “certain” LMP no more than 56 days prior, (b) either regular menses or adequateconsistent use of a highly efficacious contraceptive protectionmethodin the three months prior to the LMP, and (c) absence of specified risk factors for ectopic pregnancy. Subjects will receive the standard medical abortion regimen used at the study site. They will be evaluated 1 week after taking the abortifacient drugs to ascertain abortion outcome, adverse events, and satisfaction.
Ethical review:Before the start of the study, this protocol and the study informed consent form were reviewed and approved by Institutional Review Board (IRB) of the Municipal Hospital Nr.1, serving the study site.
IMPACT of the PROJECT:
- RHTC team enrolled 70 patients in the first 7 months of the present study.
- Ultrasound or pelvic exam before medical abortion was not undertaken.
- In 2 cases manual vacuum aspiration was performed (VAM ) because of incomplete abortion.
- The level BHCG in the urine, was tested before and after abortion using two types of semi quantitative urine tests.
- Only one patient did not return for the monitoring visit (lost to follow -up).