Status:
UNKNOWN
Medication Abortion for Pregnancy of Unknown Location
Lead Sponsor:
Planned Parenthood League of Massachusetts
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asympt...
Eligibility Criteria
Inclusion
- Patients with an undesired pregnancy of less than or equal to 42 days gestation based on last menstrual period (LMP) who present to Planned Parenthood League of Massachusetts (PPLM)'s Greater Boston Health Center seeking medication abortion will be considered for study participation.
- Inclusion criteria:
- Positive urine or serum hCG test
- No evidence of gestational sac on transvaginal ultrasound
- Desire for medication abortion as method of pregnancy termination
- Exclusion criteria:
- Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
- Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
- High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
- Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
- LMP \> 42 days or unknown LMP
- Age less than 18 years
- Prior participation in this study
- Anticipated inability to present for scheduled follow-up visits
Exclusion
Key Trial Info
Start Date :
July 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04026789
Start Date
July 22 2019
End Date
July 31 2021
Last Update
October 5 2020
Active Locations (1)
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1
PPLM
Boston, Massachusetts, United States, 02215